Crossover Randomized Clinical Trial Research Articles

Assessing the Impact of the Prostate Cancer Patient Empowerment Program (PC-PEP) on Relationship Satisfaction, Quality of Life, and Support Group Participation: A Randomized Clinical Trial.

Background/Objectives: The Prostate Cancer Patient Empowerment Program (PC-PEP) is a 6-month, home-based intervention aimed at enhancing mental health in men undergoing curative prostate cancer treatment. This exploratory secondary analysis evaluates PC-PEP's impact on relationship satisfaction, quality of life, and support group attendance among partnered participants. Methods: In a crossover randomized clinical trial ClinicalTrials.gov identifier: NCT03660085) of 128 men aged 50-82 scheduled for curative prostate cancer surgery or radiotherapy, 119 participants in relationships were included. Of these, 59 received the 6-month PC-PEP intervention, while 60 were randomized to a waitlist-control arm, receiving standard care for 6 months before starting PC-PEP. The intervention included daily emails with video instructions on mental and physical health, diet, social support, fitness, stress reduction, and intimacy. Outcomes were assessed using the Dyadic Adjustment Scale (DAS) and the Functional Assessment of Cancer Therapy-Prostate (FACT-P). Results: While relationship satisfaction remained stable, a significant improvement in emotional well-being was observed at 12 months in participants undergoing radiation therapy (p = 0.045). The PC-PEP intervention also led to significantly higher support group attendance at both 6 months (p = 0.001) and 12 months (p = 0.003), emphasizing its role in fostering social support and community engagement. Conclusions: The PC-PEP program effectively maintains relationship satisfaction and enhances emotional well-being, particularly in patients with fewer physical side effects. Its design promotes comprehensive care by integrating physical, psychological, and social support, making it a valuable resource for improving the quality of life in prostate cancer patients and potentially applicable to other cancer types.

Arm Position and Blood Pressure Readings

Guidelines for blood pressure (BP) measurement recommend arm support on a desk with the midcuff positioned at heart level. Still, nonstandard positions are used in clinical practice (eg, with arm resting on the lap or unsupported on the side). To determine the effect of different arm positions on BP readings. This crossover randomized clinical trial recruited adults between the ages of 18 and 80 years in Baltimore, Maryland, from August 9, 2022, to June 1, 2023. Participants were randomly assigned to sets of triplicate BP measurements with the arm positioned in 3 ways: (1) supported on a desk (desk 1; reference), (2) hand supported on lap (lap), and (3) arm unsupported at the side (side). To account for intrinsic BP variability, all participants underwent a fourth set of BP measurements with the arm supported on a desk (desk 2). The primary outcomes were the difference in differences in mean systolic BP (SBP) and diastolic BP (DBP) between the reference BP (desk 1) and the 2 arm support positions (lap and side): (lap or side - desk 1) - (desk 2 - desk 1). Results were also stratified by hypertensive status, age, obesity status, and access to health care within the past year. The trial enrolled 133 participants (mean [SD] age, 57 [17] years; 70 [53%] female); 48 participants (36%) had SBP of 130 mm Hg or higher, and 55 participants (41%) had a body mass index (calculated as weight in kilograms divided by height in meters squared) of 30 or higher. Lap and side positions resulted in statistically significant higher BP readings than desk positions, with the difference in differences as follows: lap, SBP Δ 3.9 (95% CI, 2.5-5.2) mm Hg and DBP Δ 4.0 (95% CI, 3.1-5.0) mm Hg; and side, SBP Δ 6.5 (95% CI, 5.1-7.9) mm Hg and DBP Δ 4.4 (95% CI, 3.4-5.4) mm Hg. The patterns were generally consistent across subgroups. This crossover randomized clinical trial showed that commonly used arm positions (lap or side) resulted in substantial overestimation of BP readings and may lead to misdiagnosis and overestimation of hypertension. ClinicalTrials.gov Identifier: NCT05372328.

The Cancer Patient Empowerment Program: A Comprehensive Approach to Reducing Psychological Distress in Cancer Survivors, with Insights from a Mixed-Model Analysis, Including Implications for Breast Cancer Patients.

Psychological distress is a significant concern among cancer patients, negatively affecting their quality of life and adherence to treatment. The Cancer Patient Empowerment Program (CancerPEP) was developed as a comprehensive, home-based intervention aimed at reducing psychological distress by incorporating physical activity, dietary guidance, and social support. This study aimed to evaluate the feasibility, accrual and attrition rates, safety, and effectiveness of the CancerPEP intervention, with and without the biofeedback device, on psychological distress from baseline to 6 months, specifically focusing on the effects of group randomization and the difference between pre- and post-intervention results. This single-site, crossover randomized clinical trial included 104 cancer patients who were randomized to receive the CancerPEP intervention, with or without a Heart Rate Variability (HRV) biofeedback monitor. At 6 months, participants who did not receive the device were allowed to use one until the end of the year, while those who did receive the device were followed up to 12 months. Randomization was stratified by the presence or absence of clinically significant psychological distress and metastatic status. Psychological distress was assessed using the Kessler Psychological Distress Scale (K10) at baseline, 6 months, and 12 months. The primary endpoint was the presence of nonspecific psychological distress, as measured by the K10 scale at 6 months from the trial start, based on group randomization. A secondary exploratory analysis assessed psychological distress at baseline, 6 months, and 12 months for both groups, while controlling for group randomization and prognostic covariates. Prognostic covariates included age; comorbidities; time between diagnosis and randomization; treatment modality; relationship status; and use of prescribed medications for anxiety, depression, or both. An exploratory sub-analysis was conducted for the breast cancer subgroup, based on the sample size available after recruitment. The trial is registered at ClinicalTrials.gov (NCT05508412). The provision of the HRV biofeedback monitor in conjunction with the CancerPEP intervention did not significantly affect the primary outcome in either the full sample or the breast cancer subgroup, indicating that the HRV biofeedback provision was not beneficial in this trial. No self-reported or otherwise discovered adverse events at the 6-month mark were observed. About 10% of participants were lost to follow-up in both the early and late HRV monitor provision groups. Participation in the CancerPEP program led to a significant reduction in psychological distress over time. The odds of psychological distress were significantly higher at the start of the trial than at the end of the intervention (aOR = 2.64, 95% CI: 1.53-4.56) or 6 months after the intervention (aOR = 2.94, 95% CI: 1.62-5.30). Similarly, in the breast cancer subgroup, distress was higher at the trial's start than at 6 months, i.e., after the intervention (aOR = 2.25, 95% CI: 1.24-4.08), or at the end of the trial at 12 months (aOR = 2.73, 95% CI: 1.35-5.52). CancerPEP significantly reduces psychological distress in cancer patients, with consistent improvements noted across various cancer types and stages, including benefits specifically for breast cancer patients. These findings build upon the success of the Prostate Cancer Patient Empowerment Program (PC-PEP), indicating that a similar comprehensive intervention can be advantageous for all cancer patients and may be further tailored to address specific needs. With its holistic approach-encompassing physical, dietary, and psychosocial support-CancerPEP shows promise as a vital component of survivorship care. Ongoing 24-month evaluations will yield critical data on its long-term benefits. Additionally, a randomized trial with a control group (usual care without intervention) for breast cancer patients is currently under way and could potentially guide the integration of CancerPEP into standard oncology care to enhance patient outcomes and quality of life.

Acute Affective Responses to Virtual Reality Exercise: A Crossover Randomized Clinical Trial.

Virtual reality (VR) exercise aims to offer positive affective and sensory experiences through an immersive experience rich in audiovisual stimuli. Notwithstanding, there is a paucity of large sample size studies comparing the acute effects of VR exercise compared with a matched exercise performed in a non-VR environment. The study compared the acute effects of a VR exercise session versus a matched non-VR exercise session in effect, pleasure, enjoyment, perceived exertion, and heart rate. This is a crossover randomized clinical trial. The time, difficulty, and exercise type of the non-VR exercise were matched to VR exercise. Before and immediately after each session, participants responded to the Borg's Perceived Exertion Scale, the Feeling Scale and the Felt Arousal Scale, and the Physical Activity Enjoyment Scale. The analyses were conducted with Generalized Linear Models, Wilcoxon's, and T-test for paired samples. A total of 83 adults (40 females) aged 35.46 years were included in the study. Participants in the VR condition had a greater increase in affect (mean change difference = 0.95, 95% confidence interval [CI] = 0.83-1.06, P < 0.001), arousal (mean change difference = 0.37, 95% CI = 0.23-9.50, P < 0.001). The pleasure and enjoyment median after the VR session were higher. In conclusion, the immersive VR exercise was more strenuous, but resulted in a better affective response, greater pleasure, and enjoyment.

E-Cigarette Nicotine Delivery Among Young Adults by Nicotine Form, Concentration, and Flavor

Concerns have been raised about the abuse liability of modern e-cigarettes that use acidic additives to form nicotine salts, making the inhalation of nicotine smoother than freebase nicotine. To examine the effects of nicotine form and concentration and e-liquid flavor on subjective effects ratings, vaping behavior, and nicotine uptake among young adults who use e-cigarettes. In this single-blind, within-participant, crossover randomized clinical trial, a convenience sample of young adults aged 21 to 25 years who currently used e-cigarettes was recruited from December 2021 to August 2023, for in-person research laboratory visits in Columbus, Ohio. Participants completed up to 9 vaping sessions, starting with their usual e-cigarette brand in the first session followed by 1 of 8 laboratory-prepared e-liquids in a randomly assigned order in each subsequent session. Prepared e-liquids varied by nicotine form (salt-based vs freebase), nicotine concentration (5% vs 1% weight per weight), and flavor (menthol vs tobacco). Each session included a 5-minute, 10-puff standardized vaping period followed by 30 minutes of ad libitum vaping. At 4 time points (0, 5, 10, and 35 minutes) during each vaping session, plasma samples were collected for assessing nicotine uptake, and self-reports of urges, craving, and withdrawal were collected via questionnaires. Positive subjective effects were self-reported after 35 minutes of vaping using a visual analog scale; urges and cravings were reported using the Questionnaire of Smoking Urges (QSU). Puff topography data were collected throughout each vaping session. Seventy-two participants (mean [SD] age, 22.4 [1.4] years; 42 [58.3%] female) who sampled at least 1 laboratory-prepared e-liquid composed the analytic sample. Salt-based (vs freebase) nicotine e-liquids increased nicotine intake, with 5% salt-based e-liquids delivering the highest mean plasma levels of nicotine (11.2 ng/mL [95% CI, 9.3-13.2 ng/mL] at 5 minutes; 17.2 ng/mL [95% CI, 14.3-20.1 ng/mL] at 35 minutes) irrespective of flavors. Higher positive subjective effect ratings (eg, for liking) were received by salt-based (42.8; 95% CI, 39.4-46.1) vs freebase (32.0; 95% CI, 28.6-35.3) nicotine, 1% (43.4; 95% CI, 40.2-46.6) vs 5% (31.2; 95% CI, 27.7-34.6) nicotine, and menthol-flavored (43.2; 95% CI, 39.7-46.7) vs tobacco-flavored (31.5; 95% CI, 28.4-34.7) e-liquids. Salt-based and 1% but not menthol-flavored nicotine elicited more intense puffing (eg, 25% [95% CI, 12%-40%] more total puffs for nicotine salts vs freebase). All study e-liquids reduced urges and cravings, with 5% vs 1% nicotine being more effective (mean [SE] QSU-Desire score at 35 minutes, 15.4 [0.5] vs 16.7 [0.5]). In this crossover randomized clinical trial among young adult e-cigarette users, salt-based (vs freebase) nicotine e-liquids increased nicotine intake and yielded more positive subjective effects ratings and intense puffing behaviors, suggesting higher abuse potential. Restricting the level of acidic additives and menthol flavoring may reduce the addictiveness of e-cigarettes. ClinicalTrials.gov Identifier: NCT05458895.

Evaluation of the Effects of Punica granatum Flower Tablets on Pain and Healing of Minor Recurrent Aphthous Stomatitis: A Randomized Clinical Trial.

The purpose of this study was to determine the therapeutic effect of the Punica granatum (PG) flower on recurrent aphthous stomatitis in comparison with corticosteroid therapy. This cross-over randomized clinical trial was conductedon the patients who had been referred to Shiraz Dental School for their RAS in 2021. All the participants used both P. granatum flower tablets and Triadent a month apart for wash-out time and all compared themselves. In the experimental group, 30 patients received pomegranate flower tablets, three tablets daily, for 6 days. In the control group, oral paste Triadent has been prescribed three times a day for 6 days. The visual analog scale (VAS) and the size of RAS were evaluated on Days 0-6. Data were analyzed by SPSS version 21. The Wilcoxon test was used. The mean age of participants was 27.8 ± 14.77 years old. In this study, 15 patients (50%) were men and 15 patients (50%) were women. The mean value of VAS after using prescribed treatment in both evaluated groups on all days was significantly different such that the VAS values were lower for PG flower tablets than Triadent (p value < 0.05). The size of oral lesions in participants who used PG flower tablets was significantly less than those who used Triadent on all evaluation days (p value < 0.05) except on Day 1 (p value = 0.29). The descending slope of VAS from Days 1 to 6 for both Triadent and PG flower tablet users was significant and noticeable. (p value < 0.05). According to the result of this study, both P. granatum flower tablet and Triadent are useful in reducing the size, period of healing, and VAS of patients with RAS, but the PG flower tablet is more effective.

Social functioning predicts individual changes in EEG microstates following intranasal oxytocin administration: Adouble-blind, cross-over randomized clinical trial.

Oxytocin (OXT) modulates social behaviors. However, the administration of exogenous OXT in humans produces inconsistent behavioral changes, affecting future consideration of OXT as a treatment for autism and other disorders with social symptoms. Inter-individual variability in social functioning traits might play a key role in how OXT changes brain activity and, therefore, behavior. Here, we investigated if inter-individual variability might dictate how single-dose intranasal OXT administration (IN-OXT) changes spontaneous neural activity during the eyes-open resting state. We used a double-blinded, randomized, placebo-controlled, cross-over design on 30 typically developing young adult men to investigate the dynamics of EEG microstates corresponding to activity in defined neural networks. We confirmed previous reports that, at the group level, IN-OXT increases the representation of the attention and salience microstates. Furthermore, we identified a decreased representation of microstates associated with the default mode network. Using multivariate partial least square statistical analysis, we found that social functioning traits associated with IN-OXT-induced changes in microstate dynamics in specific spectral bands. Correlation analysis further revealed that the higher the social functioning, the more IN-OXT increased the appearance of the visual network-associated microstate, and suppressed the appearance of a default mode network-related microstate. The lower the social functioning, the more IN-OXT increases the appearance of the salience microstate. The effects we report on the salience microstate support the hypothesis that OXT regulates behavior by enhancing social salience. Moreover, our findings indicate that social functioning traits modulate responses to IN-OXT and could partially explain the inconsistent reports on IN-OXT effects.

Optimistic vs Pessimistic Message Framing in Communicating Prognosis to Parents of Very Preterm Infants

In the neonatal intensive care unit, there is a lack of understanding about how best to communicate the prognosis of a serious complication to parents. To examine parental preferences and the effects of optimistic vs pessimistic message framing when providing prognostic information about a serious complication. This crossover randomized clinical trial was conducted at a single German university medical center between June and October 2021. Eligible participants were parents of surviving preterm infants with a birth weight under 1500 g. Data were analyzed between October 2021 and August 2022. Alternating exposure to 2 scripted video vignettes showing a standardized conversation between a neonatologist and parents, portrayed by professional actors, about the prognosis of a hypothetical very preterm infant with severe intraventricular hemorrhage. The video vignettes differed in the framing of identical numerical outcome estimates as either probability of survival and probability of nonimpairment (optimistic framing) or a risk of death and impaired survival (pessimistic framing). The primary outcome was preference odds (ratio of preference for optimistic vs pessimistic framing). Secondary outcomes included state anxiety, perceptions of communication, and recall of numerical estimates. Of 220 enrolled parents (142 [64.5%] mothers; mean [SD] age: mothers, 39.1 [5.6] years; fathers, 42.7 [6.9] years), 196 (89.1%) preferred optimistic and 24 (10.1%) preferred pessimistic framing (preference odds, 11.0; 95% CI, 6.28-19.10; P < .001). Preference for optimistic framing was more pronounced when presented second than when presented first (preference odds, 5.41; 95% CI, 1.77-16.48; P = .003). State anxiety scores were similar in both groups at baseline (mean difference, -0.34; -1.18 to 0.49; P = .42) and increased equally after the first video (mean difference, -0.55; 95% CI, -1.79 to 0.69; P = .39). After the second video, state anxiety scores decreased when optimistic framing followed pessimistic framing but remained unchanged when pessimistic framing followed optimistic framing (mean difference, 2.15; 95% CI, 0.91 to 3.39; P < .001). With optimistic framing, participants recalled numerical estimates more accurately for survival (odds ratio, 4.00; 95% CI, 1.64-9.79; P = .002) but not for impairment (odds ratio, 1.50; 95% CI, 0.85-2.63; P = .16). When given prognostic information about a serious complication, parents of very preterm infants may prefer optimistic framing. Optimistic framing may lead to more realistic expectations for survival, but not for impairment. German Clinical Trials Register (DRKS): DRKS00024466.

Immediate effects of myofascial release to the pectoral fascia on posture, range of motion, and muscle excitation: a crossover randomized clinical trial

ABSTRACT Context Forward shoulder posture (FSP) is a risk factor for shoulder pathology. Manual therapists often use myofascial release (MFR) to elongate restricted pectoral fascia to reduce FSP and improve shoulder function; however, the effects of this treatment approach remain anecdotal. Objective Determine the acute effects of 4-min of MFR, compared to a soft-touch control (CON), to the pectoral fascia on: 1) FSP, 2) shoulder horizontal abduction ROM (HA-ROM), and 3) muscle excitation of the trapezius (upper, middle, lower [UT, MT, LT]) and pectoralis major (PEC). Methods Fifty-nine right-handed participants (27 ± 9 years, 30 female) with FSP, but otherwise asymptomatic shoulders participated in a randomized crossover clinical trial by attending two experimental sessions: one MFR and one CON treatment, each administered by a Registered Massage Therapist. FSP, HA-ROM, and muscle excitation during a reaching task, were measured before and after each treatment. Results There was a significant interaction between treatment and time for FSP (p = .018, ηp = .093) with FSP decreasing from PRE MFR (128 ± 19 mm) to POST MFR (123 ± 19 mm; p < .001, ηp = .420) and PRE CON (126 ± 19 mm) to POST CON (124 ± 18 mm; p < .001, ηp = .191) interventions. There were no significant differences in HA-ROM or muscle excitation. Conclusion Four minutes of MFR or CON to the pectoral fascia acutely reduces FSP.

Comparison of speech changes caused by four different orthodontic retainers: a crossover randomized clinical trial.

This study aimed to compare the influence of four different maxillary removable orthodontic retainers on speech. Eligibility criteria for sample selection were: 20-40-year subjects with acceptable occlusion, native speakers of Portuguese. The volunteers (n=21) were divided in four groups randomized with a 1:1:1:1 allocation ratio. The four groups used, in random order, the four types of retainers full-time for 21 days each, with a washout period of 7-days. The removable maxillary retainers were: conventional wraparound, wraparound with an anterior hole, U-shaped wraparound, and thermoplastic retainer. Three volunteers were excluded. The final sample comprised 18 subjects (11 male; 7 female) with mean age of 27.08 years (SD=4.65). The speech evaluation was performed in vocal excerpts recordings made before, immediately after, and 21 days after the installation of each retainer, with auditory-perceptual and acoustic analysis of formant frequencies F1 and F2 of the vowels. Repeated measures ANOVA and Friedman with Tukey tests were used for statistical comparison. Speech changes increased immediately after conventional wraparound and thermoplastic retainer installation, and reduced after 21 days, but not to normal levels. However, this increase was statistically significant only for the wraparound with anterior hole and the thermoplastic retainer. Formant frequencies of vowels were altered at initial time, and the changes remained in conventional, U-shaped and thermoplastic appliances after three weeks. The thermoplastic retainer was more harmful to the speech than wraparound appliances. The conventional and U-shaped retainers interfered less in speech. The three-week period was not sufficient for speech adaptation.

We choose: Adolescent girls and young women's choice for an HIV prevention product in a cross-over randomized clinical trial conducted in South Africa, Uganda, and Zimbabwe.

With new pre-exposure prophylaxis (PrEP) modalities for HIV prevention becoming available, understanding how adolescent girls and young women (AGYW) navigate through PrEP options is essential, including factors underlying their choice. Through 16 focus group discussions (FGDs) and 52 in-depth interviews (IDIs) from REACH, an open-label crossover study in which AGYW were allocated 1:1 (between 06 February 2019 and 18 March 2020) to receive oral PrEP for six months and the dapivirine ring for six months, in a randomized sequence, followed by a 6-month period where either product (or neither) could be chosen, we explored decision-making process and product choice, using a mixed inductive-deductive analytical approach. Key themes included the desire to remain HIV-negative and weighing product attributes through experiential learning. Product triability appeared important in informing product choice as individual circumstances changed or assuaging side effects with a given product. Approved biomedical prevention innovations may also benefit from hands-on experience to help with adoption and use during real-world implementation. Furthermore, support from trusted providers will remain critical as AGYW contemplate navigating through PrEP options and choice.

Religiosity, Anxiety, Depression, and Suicidal Ideation in Brazilian Patients with Sickle Cell Disease

Introduction: Sickle cell disease (SCD) is an inherited hemoglobinopathy that can evolve with time, in some individuals, as a debilitating chronic pain syndrome with emotional dysfunctions. Objective: To evaluate different types of religiosities: organizational (ORA), non-organizational (NORA), and intrinsic religiosity (IR), and their correlation with mental health in individuals with SCD. The variables analyzed were depression, anxiety, and catastrophic and suicidal thoughts. Method: This is a descriptive cross-sectional study, which is part of a crossover randomized clinical trial. We recruited adults among individuals with SCD from Bahia-Brazil. We used: Duke's religiosity index, Hospital Anxiety and Depression Scale (HADS), and Brazilian Portuguese Pain Catastrophizing Scale (BP-PCS) data. The Spearman correlation and Fisher exact test were used for statistics considering alpha 95%. Results: Of the 131 individuals approached for participation, 75 completed all questionnaires with genotype HbSS and HbSC. Of them, 49 (65,3%) were women, with an average age of 34.13 +10.02, 66 (88.0%) self-declared black, 63 (84.0%) declared to belong to a religious group, 67 (89.3%) with a high form of religious involvement. The mean of intense pain was 3.86 + 2.74; 40 (53.33%) had anxiety, 25 (33.33%) had depression, and 15 (20.0%) declared having suicidal thoughts. There was a negative correlation between depression and IR (r = -0.240, p = 0.038) and a correlation between average pain and NORA (r = 0.301, p = 0.009). An association between NORA and chronic pain was verified (p = 0.023), OR (p &lt; 0.001), NORA (p = 0.042), and IR (p = 0.004) with evangelical SCD subjects. Conclusion: This study highlights the need for mental health care in patients with SCD due to the high rates of anxiety and depression, with the need to include religiosity since it is a frequent and important element in the lives of people with SCD.&#x0D;

Effects of estrogen and progesterone on neuroactive steroids and cytokines in patients with suicidality

BackgroundIn ovulating psychiatric patients experiencing suicidality, suicidal ideation (SI) often peaks perimenstrually. Our recent double-blind, placebo-controlled, crossover randomized clinical trial (RCT; NCT03720847) showed that perimenstrual administration of estradiol and progesterone (EP) can prevent this peak in SI and depressed mood. In this pre-registered follow-up analysis, we studied how the menstrual cycle and experimental manipulation affected two neurobiological systems associated with the menstrual cycle and suicide risk: GABAergic neuroactive steroids (NAS) and peripheral cytokines. MethodsIn 26 psychiatric outpatients with natural menstrual cycles and past-month SI, we analyzed serum samples from three blood draws (midluteal, perimenstrual, midfollicular) per experimental condition (EP vs placebo) timed to a luteinizing hormone-surge ovulation test. Using gas chromatography/mass spectrometry (GC/MS), we measured the progesterone (P4)-derived pregnane NAS (3α,5α)− 3-hydroxypregnan20-one (3α,5α-THP), (3α,5β)− 3-hydroxypregnan-20-one (3α,5β-THP), (3α,5α)− 3,21-dihydroxypregnan-20-one (3α,5α-THDOC), (3α,5α)− 3-hydroxyandrostan-17-one (3α,5α-A), the androstane NAS (3α,5β)− 3-hydroxyandrostan-17-one (3α,5β-A), (3α,5α,17β)-androstane-3,17-diol (3α,5α-A-diol), (3α,5β,17β)-androstane-3,17-diol (3α,5β-A-diol), and their precursor pregnenolone. High sensitivity multiplex assay kits quantified peripheral cytokines IL-1β, IL-6, and TNF-α. ResultsP4-derived NAS fluctuated in parallel with P4 and increased with exogenous perimenstrual administration of EP. Conversely, androstane NAS either did not fluctuate or fluctuated inversely from P4, and these NAS decreased with exogenous EP. Peripheral cytokines did not show cyclical patterns, but each significantly predicted SI, depressed mood, or anxiousness. Concomitant SSRI medication use predicted lower androstane NAS. ConclusionsWhile preliminary and exploratory, our findings provide critical descriptive context for future studies. Further, our work presents menstrual cycle-related patterns for ten frequently-studied biomarkers, allowing for improved quality of comparisons involving naturally-cycling populations in research.

Diagnostic accuracy of hand-held colposcope (Gynocular) in comparison with standard colposcope in patients with abnormal cervical cytology or visual inspection with acetic acid positivity: a cross over randomized controlled study.

To compare the diagnostic accuracy of a handheld colposcope (Gynocular) versus a standard colposcope in women with abnormal cervical cytology or visual Inspection with acetic acid positivity. This crossover randomized clinical trial was conducted in Pondicherry, India, and included 230 women who were referred for colposcopy. Swede scores were calculated using both colposcopes, and a cervical biopsy was performed from the most visually abnormal areas. Swede scores were compared with the histopathological diagnosis, which was used as the reference standard. The level of agreement between the two colposcopes was calculated using Kappa (κ) statistics. The level of agreement of Swede scores between the standard and Gynocular colposcopes was 62.56%, and the κ statistic was 0.43 (P<0.001). Cervical intraepithelial neoplasia (CIN) 2+ (CIN 2, CIN 3, CIN 3+) was diagnosed in 40 (17.4%) women. There were no significant differences between the two colposcopes in terms of sensitivity, specificity, or predictive value for detecting CIN 2+ lesions. The diagnostic accuracy of Gynocular colposcopy was similar to that of standard colposcopy for detecting CIN 2+ lesions. Gynocular colposcopes showed a good level of agreement with standard colposcopes when the Swede score was used.

Clinical Efficacy of Two Denture Adhesives Among Complete Denture Patients: A Cross-over Randomized Clinical Trial

Aims and objectives: The clinical efficacy of different forms of denture adhesives have been inconsistent among studies with unclear differences among them. The aim of this study is to evaluate the masticatory efficiency and satisfaction of complete denture wearers without and with the use of two different forms of commercially available denture adhesives.&#x0D; Material and Methods: 30 edentulous participants with new complete dentures placed one month before the commencement of the study were included in this cross-over randomized clinical trial (CTRI/2021/07/035238) which compared a powder adhesive and a cream adhesive along with no adhesive use. The objective assessment used the Edlund and Lamm index for masticatory efficiency and the subjective assessment followed a specially designed questionnaire. Both assessments were carried out on days 0,7 and 21. One-way ANOVA was used to compare the objective data and the questionnaire responses were obtained as percentages.&#x0D; Results: The one-way ANOVA test for difference between the groups was statistically insignificant for all layers (P&gt;.05). The questionnaire responses revealed that 53.3% of the participants preferred the use of cream adhesive over powder adhesive.&#x0D; Conclusions: No significant difference in the masticatory efficiency was noted between the two denture adhesives and without adhesive use. Patient satisfaction was greater with adhesive use showing a predilection towards cream adhesive due to its longer duration of action and improved chewing ability.

Training spatial hearing in unilateral cochlear implant users through reaching to sounds in virtual reality

Background and PurposeUse of unilateral cochlear implant (UCI) is associated with limited spatial hearing skills. Evidence that training these abilities in UCI user is possible remains limited. In this study, we assessed whether a Spatial training based on hand-reaching to sounds performed in virtual reality improves spatial hearing abilities in UCI usersMethodsUsing a crossover randomized clinical trial, we compared the effects of a Spatial training protocol with those of a Non-Spatial control training. We tested 17 UCI users in a head-pointing to sound task and in an audio-visual attention orienting task, before and after each training. <br>Study is recorded in clinicaltrials.gov (NCT04183348).ResultsDuring the Spatial VR training, sound localization errors in azimuth decreased. Moreover, when comparing head-pointing to sounds before vs. after training, localization errors decreased after the Spatial more than the control training. No training effects emerged in the audio-visual attention orienting task.ConclusionsOur results showed that sound localization in UCI users improves during a Spatial training, with benefits that extend also to a non-trained sound localization task (generalization). These findings have potentials for novel rehabilitation procedures in clinical contexts.

Cooling spray or lidocaine spray and needle insertion pain in hemodialysis patients: an open-label cross-over randomized clinical trial

BackgroundThe needle insertion pain to perform hemodialysis is the main challenge and a common problem that requires pain management techniques for patients’ comfort.AimThis study aimed to compare the effects of cooling and lidocaine sprays on needle insertion pain in hemodialysis patients.MethodsIn this randomized cross-over clinical trial study, the hemodialysis patients were selected through convenience sampling according to inclusion criteria and randomly assigned to three intervention groups using the block randomization method. Each patient received three interventions in a cross-over design: Cooling spray or 10% lidocaine spray or placebo spray. There was a 2-week wash-out time between each intervention. The pain score was measured four times for each patient by the Numerical Rating Scale.ResultsForty-one hemodialysis patients were included. The results showed a significant interaction between time and group (p < 0.05), so only observations of time 1 with adjustment for baseline values were used to evaluate the effect of the intervention. Patients receiving cooling spray reported 2.29 less pain score on average compared to placebo (B=-2.29, 95% CI: -4.17 to -0.43; p < 0.05); Also, patients receiving cooling spray reported a 1.61 lower pain score than those receiving lidocaine spray, but this difference was not statistically significant (95% CI: -0.26 to 3.48; p > 0.05).ConclusionThe cooling spray was effective in reducing the needle insertion pain. Although it was impossible to compare the pain scores at different times and following different interventions, the present study results can help supplement the existing knowledge regarding cooling and lidocaine sprays.

Effect of miswak chewing sticks on Oral Helicobacter Pylori under both fasting and non-fasting conditions – A preliminary cross-over randomized clinical trial

ObjectivesThe chewing stick or “miswak” has demonstrated growth-inhibitory effects on several oral micro-organisms including Helicobacter pylori (H. pylori). This study explores the effect of miswak on oral H. pylori among fasting and non-fasting subjects. MethodsThis cross-over randomized clinical study included 40 subjects. Twenty subjects were on 12-hour fasting and 20 subjects were not fasting. At baseline (T0), clinical periodontal parameters were recorded, and the participants were instructed on the use of toothbrush alone or toothbrush with miswak in a cross-over manner, for a period of two weeks each. Plaque and salivary samples were collected at T0, after two weeks (T1) and after 4 weeks (T2). Quantification of H. pylori from the plaque and salivary samples were performed by real-time polymerase chain reaction (qPCR). ResultsThere were 28 males and 12 females, and the mean age of the participants was 29.5 ± 7.1 years. At baseline, the median count of H. pylori was 27.61 × 103 cells/mL. The non-fasting group had significantly (p < 0.05) higher quantities of H. pylori, in both the plaque and the salivary samples, as compared with the fasting group. At T0, a statistically significant correlation was observed between the quantities of H. pylori in the dental plaque and selected clinical periodontal parameters (p < 0.05). For non-fasting subjects, a statistically significant reduction in the H. pylori counts was observed in the dental plaque samples on using miswak and toothbrush (p < 0.05). ConclusionNon-fasting subjects showed significant reduction in the H. pylori counts in dental plaque by complementing miswak chewing sticks with toothbrushing.

A Comprehensive 6-mo Prostate Cancer Patient Empowerment Program Decreases Psychological Distress Among Men Undergoing Curative Prostate Cancer Treatment: A Randomized Clinical Trial

BackgroundAlthough survival rates for newly diagnosed prostate cancer patients are very high, most of them will likely suffer significant treatment-related side effects, depression, or anxiety, affecting their quality of life. ObjectiveThe aim of this study was to examine the effects of a 6-mo online home-based physical, mental, and social support intervention, the Prostate Cancer Patient Empowerment Program (PC-PEP), on preventing psychological distress among men undergoing curative prostate cancer treatment. Design, setting, and participantsIn a crossover randomized clinical trial of 128 men aged 50–82 yr scheduled for curative prostate cancer surgery or radiotherapy (± hormone treatment), 66 received the 6-mo PC-PEP intervention and 62 were randomized to a waitlist-control arm and received the standard of care for 6 mo, and then PC-PEP to the end of the year. The PC-PEP intervention consisted of daily e-mails with video instructions providing education, patient activation, and empowerment on healthy living including physical and mental health, dietary recommendations, social support, physical and pelvic floor fitness, stress reduction using a biofeedback device, social connection and intimacy, and social support. Outcome measurements and statistical analysisThe primary outcome was nonspecific psychological distress (clinical cutoff ≥20) measured at baseline, and at 6 and 12 mo using the Kessler Psychological Distress Scale (K10). Results and limitationsAt 6 mo, patients in the waitlist-control group had 3.59 (95% confidence interval: 1.12–11.51) times higher odds for nonspecific psychological distress and need for psychological treatment than men who received the PC-PEP intervention. At 12 mo, the wait-list control group that received the intervention at 6 mo had higher psychological distress than the early group. ConclusionsPC-PEP delivered early following diagnosis significantly prevented the burden of psychological distress in men undergoing curative prostate cancer treatment compared with standard of care, or late (6 mo later) intervention. Patient summaryIn this report, we looked at the effectiveness of a program (Prostate Cancer Patient Empowerment Program: PC-PEP) developed with patients' engagement on the mental distress of patients awaiting curative treatment for their prostate cancer. The PC-PEP program lasted for 6 mo, and it prescribed, described, and demonstrated daily aerobic and strength training, kegels (pelvic floor training to help with urinary and sexual function), dietary changes that have been shown to be helpful in the prevention of prostate cancer and prostate cancer progression, stress reduction using a biofeedback device, as well as social and emotional support. All patients in the PC-PEP program were invited to a monthly video conference with the leads of the program who appeared in the 6 mo of daily videos prescribing the activities the patients were asked to watch and follow. The leads were a prostate cancer oncologist and a scientist in prostate cancer quality of life research. Half of the patients in this study received PC-PEP daily for the first 6 mo and were re-assessed at the end of the year. The other half received standard of care for 6 month and then received the intervention to the end of the year. The results of the study show that, at 6 mo, this intervention was effective at reducing the mental distress that accompanies a prostate cancer diagnosis and treatment compared with the standard of care. Mental distress was significantly reduced when the intervention was received early, compared with that received late (6 mo after scheduled curative treatment). We conclude that multi-faceted patient education and empowerment programming of this kind that is developed with patient engagement from the start is crucial to the care of patients diagnosed with prostate cancer and should be implemented in the standard of care. While treatment for prostate cancer is highly successful, side effects that accompany most treatments significantly affect the quality of life of patients. Here, we describe PC-PEP, a patient education and activation program that is cost effective, highly enforced by patients, and successful at reducing the impact of prostate cancer active treatment–related side effects on their psychological state. To learn more about this project, please visit www.pcpep.org. The program is now being tested in a phase 4 implementation trial throughout Canada and internationally (New Zealand), and is being expanded and tested for other types of cancer.

Gentle Touch and Sucrose for Pain Relief during Suctioning in Preterm Newborns-A Randomized Clinical Trial.

Pain management is challenging in neonatal care. We aimed to compare the effects of gentle touch and sucrose on pain relief during suctioning in premature newborns (PTNB). This crossover randomized clinical trial enrolled PTNBs with low birth weight, hemodynamically stable, and requiring suctioning during hospitalization in the neonatal intensive care unit. PTNBs underwent three different suctioning procedures. The first was performed without intervention (baseline). Right after, PTNBs were randomly allocated (sucrose and gentle touch or vice versa) to the next two suctioning procedures. Two validated scales assessed pain: the Neonatal Infant Pain Scale (NIPS) and the Premature Infant Pain Profile-Revised (PIPP-R). We evaluated 50 PTNBs (mean of 28 weeks) with a mean low birth weight of 1050 g; most were under continuous positive airway pressure 37 (74%) and mechanical ventilation 41 (82%). Gentle touch was efficacious for pain relief since NIPS (p = 0.010) compared to baseline. Sucrose was also effective in reducing pain NIPS and PIPP-R (p < 0.001). Although the two interventions reduced pain, no difference was observed between gentle touch and sucrose.