Randomized Control Pilot Study Research Articles

A 16-week progressive exercise training intervention in treatment-naïve chronic lymphocytic leukaemia: a randomised-controlled pilot study

BackgroundChronic lymphocytic leukaemia (CLL) typically presents with asymptomatic, early-stage disease that is monitored until disease progression (‘treatment-naïve’ CLL). The objective of this pilot study was to assess the feasibility and preliminary safety of an exercise program in treatment-naïve CLL. We also sought to preliminarily assess the impact of the exercise program on disease activity, as it has been proposed that exercise training may reduce disease outgrowth in treatment-naïve CLL.MethodsA total of 40 treatment-naïve CLL patients were recruited into this randomised-controlled pilot study, and after screening, n = 28 were randomised into a 16-week, home-based, partially supervised, personalised, progressive exercise intervention (n = 14: mean ± SD: age = 62 ± 12 years) or 16 weeks of usual care, control group (n = 14: mean ± SD: age = 61 ± 10 years). The primary outcome measures were safety (number and severity of adverse events) and feasibility (uptake, retention, and adherence to the trial). Disease activity (CD5+/CD19+ CLL cells clonally restricted to kappa or lambda) and other immune cell phenotypes, with a principal focus on T cells, were measured by flow cytometry. Other secondary outcomes included DEXA-derived body composition, cardiorespiratory and functional fitness, resting cardiovascular measures.ResultsTrial uptake was 40%, and the overall retention rate was 86%, with 79% of the exercise group and 93% of the control group completing the trial. Adherence to the exercise intervention was 92 ± 8%. One serious adverse event was reported unrelated to the trial, and one adverse event related to the trial was reported. The exercise intervention elicited a 2% increase in DEXA-derived lean mass in the exercise group compared with a 0.4% decrease in the control group (p = 0.01). No between-group differences were observed over time for whole-body mass, BMI, bone mineral density, body fat, blood pressure resting heart rate, or measures of cardiorespiratory or functional fitness (all p > 0.05). No between-group differences were observed over time for clonal CLL cells and CD4+ or CD8+ T-cell subsets (all p > 0.05).ConclusionThe exercise training program used in this study was feasible in people with treatment-naïve CLL who passed pre-trial screening, and we preliminarily conclude that the exercise training program was safe and also resulted in an increase in lean mass.Clinical trial registrationhttps://doi.org/10.1186/ISRCTN55166064, identifier ISRCTN 55166064.

The effect of core stabilization exercises on balance and functional performance in individuals with functional ankle instability: An open-label randomized controlled trial

Objectives: The objective of the study was to evaluate the effect of core stabilization exercises on balance and functional performance in functional ankle instability (FAI). Methods: An open-label randomized control pilot study was conducted with 30 FAI participants allocated to two groups. Inclusion criteria were the presence of frequent ankle sprains, sense of give-away of the ankle, and identification of FAI score >11. The experimental group (n = 15) received core stabilization exercises along with conventional exercises, whereas the control group (n = 15) received only conventional exercises. The intervention period was six weeks. The outcome measures for static balance, dynamic balance, and functional performance were the single-leg stance test, modified star excursion balance test (mSEBT), and side hop test, respectively. The assessment was done at baseline and six weeks post-intervention. Results: Within-group analysis showed improvement in the single-leg stance test and all direction reach distances of mSEBT in both groups using the Wilcoxon signed-rank test. Meanwhile, the side hop test revealed no difference between the two groups. A significant improvement was seen in mSEBT and single-leg stance scores (P ≤ 0.05) between the groups using the Mann–Whitney U-test. However, the side hop test showed no significant difference (P > 0.05). Conclusion: The present study concludes that core stabilization exercises improved balance compared to mobility and strengthening exercises. Hence, it is highly recommended that core stability training be implemented as a holistic approach to managing FAI.

Exploring the Functionality of Technology-driven CPR Training Methodologies Among Healthcare Practitioners: A Randomized Control Pilot Study.

Cardiopulmonary resuscitation training in Malaysia has evolved from traditional to modern approaches, embracing technology for better outcomes. Smartphone-based training apps offer interactive learning with simulations and real-time feedback, improving cardiopulmonary resuscitation skills anytime, anywhere. This study evaluates the effectiveness of the smart-cardiopulmonary resuscitation application for healthcare practitioners. This randomized controlled pilot study was conducted with 30 healthcare practitioners at the University of Malaysia Sabah. Participants underwent a Cardiopulmonary Resuscitation Practical formal educational training program, and data were collected using a Basic Life Support questionnaire and skills assessment checklist sourced from the American Heart Association (2020). Data analysis was conducted utilizing repeated analysis of variance and the Cochran 'Q' test supported by Statistical Package for the Social Sciences statistical software. The control and intervention groups showed improved knowledge and skills from pre-to post-cardiopulmonary resuscitation courses; a significant increase was observed in the intervention group compared to the control group. The F-test indicated a significant time-group effect (F-stat (df) = 16.14 (2), p = 0.01). Cochran's 'Q' test also revealed significant changes in the proportion of healthcare practitioners passing their skills assessments over time (2 = 14.90, control 01). The smart-cardiopulmonary resuscitation application is convenient for refreshing cardiopulmonary resuscitation skills and maintaining proficiency. While it doesn't replace formal cardiopulmonary resuscitation courses, it saves healthcare practitioners and the community time and money. Both groups showed improved cardiopulmonary resuscitation knowledge and skills, with the intervention group using the smart-cardiopulmonary resuscitation application showing higher success rates after two months. Adopting smartphone-based cardiopulmonary resuscitation training with comprehensive content is recommended.

Evaluation of chapattis fortified-diet with raw and fermented carrot powder in persons with type 2 diabetes: A randomized control pilot study

BackgroundDiabetes is a metabolic disease that is common and growing rapidly. It is characterised by high blood sugar levels and related complications to vital organs such as the kidneys, heart, blood vessels, and eyes. The most common kind of diabetes affecting people globally is type 2 diabetes (T2D). An increasing number of people are looking at natural foods and dietary supplements to manage their T2D.ObjectiveThe aim of this pilot study was to assess the glycemic index, glycemic response, sensory qualities, nutritional composition, and possible antidiabetic benefits of chapattis fortified with raw and fermented carrot powder.MethodsSeven preparations of chapattis were prepared into three variants from whole wheat flour chapattis (WWFC) as control group, raw carrot-supplemented chapattis (RCSC) with subtypes T1, T2, and T3, and fermented carrot-supplemented chapattis (FCSC) with subtypes T4, T5, and T6. The variants were provided to 11 professionally trained sensory panelists for organoleptic evaluation. The chapattis subtype with the best organoleptic properties together with the WWFC were then given randomly to a group of 30 persons with T2D respectively to see how their blood sugar levels were affected over a period of 4 weeks.Results The panelist adjudged RCSC (T2) and FCSC (T5) as the best organoleptically. The randomised control investigation demonstrated that the fasting blood glucose levels for WWFC, RCSC, and FCSC decreased (P<0.05) significantly by 6.42%, 7.24%, and 12.75%, respectively. However, there was no significant different in the fasting blood sugar between the WWFC and RCSC. As for the glycemic load values of WWC, RCSC, and FCSC, which were 21, 14, and 13, respectively, there was no statistically significant difference between RCSC and FCSC, suggesting that both types of chapattis could help T2D patients regulate their blood sugar levels. The most significant changes were consistently shown by the FCSC: 17.50% reduction in random blood sugar (p = 0.03), 21.85% reduction in serum low-density lipoprotein (p = 0.051), 16.67% increase in serum HDL (p = 0.01), 11.09% decrease in serum cholesterol (p = 0.02), and 12.575% reduction in serum triglycerides (p = 0.048).ConclusionsA beneficial dietary intervention for people with T2D may involve mixing fermented carrot powder into regular chapattis. These findings contribute to the growing body of evidence in favour of using natural food-based treatments for the management of diabetes.

A double-blinded randomised controlled study of fluid restriction versus liberal fluid during induction of labour: A pilot study.

Excess intravenous fluid for women requiring an induction of labour may adversely affect the duration of labour and maternal/neonatal outcomes. This study aimed to determine the difference in duration of labour and outcomes with a low background infusion rate, compared to liberal background intravenous fluid management. A double blind randomised controlled pilot study was performed on 200 women who underwent induction of labour at a single institution. Women were randomised to an intravenous rate of 40 mL/h versus 250 mL/h of Hartmann's solution. Fluid boluses were strictly controlled to limit bias. This trial was registered with the Australian clinical trial registry: ACTRN12621001298808. Analysis of the total amount of fluid received showed good separation with Group 1 (40 mL/h) receiving 1,736 mL less than Group 2 (250 mL/h), median (interquartile range) 841 mL (458, 1691) versus 2,577 mL (1620, 4326) (P < 0.001). Median duration of labour was shorter in Group 1 by 24 min (P = ns). Subset analysis of nulliparous women showed that duration of labour was shorter in Group 1 by 83.5 min (P = ns). As this was a pilot study, a significant difference in duration of labour or secondary outcomes was not seen. Given the increasing numbers of nulliparous women having an induction of labour, potential for adverse maternal and neonatal outcomes and the associated higher rate of operative birth, this study guides power calculations and supports proof of concept for future research into optimum fluid management during induction of labour for these women.

P14. Are Prophylactic Post-operative Antibiotics Indicated For Implant-based Breast Reconstruction?: A Randomized-controlled Pilot Study

P14. Are Prophylactic Post-operative Antibiotics Indicated For Implant-based Breast Reconstruction?: A Randomized-controlled Pilot Study

Testing of symmetric biphasic stimulation in Vim-DBS ET patients: a randomized-controlled pilot study.

Symmetric biphasic pulses have been shown to increase the therapeutic window compared to standard cathodic pulses in ET Vim-DBS patients. Furthermore, three hours of stimulation with biphasic pulses caused less stimulation-induced ataxia compared to cathodic pulses. Therefore, an investigation of the longer-term safety of biphasic pulses is warranted. Seven ET patients were included in a randomized double-blind, cross-over design of one week home-use of symmetric biphasic stimulation (anodic phase first) versus cathodic stimulation. Amplitude was set in a double-blinded way, at the tremor arrest threshold. The primary outcome was safety assessed by documenting the adverse events. Secondary outcome parameters were stimulation amplitude, tremor (Fahn-Tolosa-Marin Tremor Rating Scale) and ataxia (International Cooperative Ataxia Rating Scale) severity, quality of life (Quality of Life in Essential Tremor Questionnaire) and cognition (Montreal Cognitive Assessment). Three patients continued in the open-label extension phase for 3 months, during which biphasic stimulation-only was further assessed by the same outcome parameters. During the 1 week testing, no adverse effects were reported. To obtain equivalent tremor control, the amplitude of the biphasic pulse was significantly higher compared to that of the cathodic pulse (p = 0.003). The other outcome parameters were not significantly different. During the open-label study, one patient used the remote control to increase the amplitude, leading to two falls caused by stimulation-induced ataxia. No other adverse effects occurred. In a small cohort, when tested for one week, symmetric biphasic pulses suggest to be safe, but require higher stimulation amplitudes. Further follow-up studies are needed to investigate long-term effects and safety.

Posttonsillectomy Pain Relief and Wound Healing by Applying Bismuth Iodoform Paraffin Paste (BIPP) to Dissected Tonsillar Beds.

Introduction Tonsillectomy is one of the most common operations performed by otorhinolaryngology surgeons worldwide; however, the insufficient quality of the postoperative pain management and effective posttonsillectomy pain relief remain a clinical dilemma. Objective To evaluate the efficacy of applying bismuth iodine paraffin paste (BIPP) to the dissected fossa as an adjuvant therapy for a better outcome in terms of posttonsillectomy pain management and due to its wound healing properties. Methods The present is a prospective randomized control pilot study with 44 patients aged > 7 years who underwent tonsillectomy. The patients were divided into two groups: the control group and the group that had BIPP applied to the dissected tonsillar fossa. The visual analogue scale score and the post-onsillectomy percentage of tonsillar fossa epithelization were recorded and evaluated. Results Both subjectively and objectively, there a was statistically significant pain-relieving effect in the BIPP group within the first 5 postoperative days ( p < 0.05). From postoperative day 3 onward, the dissected area of the tonsillar fossa healed significantly faster in the BIPP group compared with the control group, and it became stable on day 14. Conclusion The topical application of BIPP showed a better pain-relieving effect, it was safe, and hastened wound healing after tonsillectomy.

Feasibility, Clinical Efficacy, and Maternal Outcomes of a Remote Exercise Program in Pregnant Women with Obesity: The GROB Randomized Control Pilot Study

Background: Obesity is common in women of reproductive age and increases the risk during pregnancy. Exercising during this period reduces health complications. Home e-health programs are effective in overcoming exercise barriers as pregnant women use technology and the internet for health information. Methods: A single-blind randomized controlled feasibility study with pregnant women with obesity (body mass index [BMI] ≥30 kg/m2) was conducted in the University Hospital Center of São João between January and April 2023. Pregnant women were randomized to a control group with standard care and to an experimental group with 8-week remote exercise program using a Phoenix® biofeedback device. Feasibility outcome measures were recruitment rate (≥35%), loss to follow-up (≤15%), and program fidelity (≥1 session/week). Secondary outcomes were evaluated through Pregnancy Physical Activity Questionnaire, Oswestry Index on Disability, and weight assessments at baseline and at the end of the program. Results: Of the 63 eligible participants, 24 (38.1%) were successfully randomized and completed the baseline assessment. Of these, 3 (4.8%) from experimental group did not perform the initial onboarding. The control group had 8.3% of follow-up losses and for the experimental group there were no follow-up losses. Program fidelity (mean ≥1 session/week) was fulfilled by 66.7% of successfully randomized participants. Regarding secondary outcomes assessed between baseline and the 8th week, experimental group compared to control group had higher levels of physical activity for sports activities, a lower level of inactivity, and lower disability rates caused by low back pain. Conclusions: Based on the recruitment rate, losses to follow-up, and fidelity rate, the GROB (obesity in pregnancy) study was deemed feasible and worthy of consideration for a larger study. Moreover, the GROB study has the potential to improve maternal outcomes by reducing sedentarism and disability caused by low back pain. Clinical Trial Registration: The study has been registered on https://classic.clinicaltrials.gov/ (registration number: NCT05331586).

RESP-FIT: A Technology-Enhanced Combined Inspiratory and Expiratory Muscle Strength Training Intervention for Adults With COPD.

Chronic obstructive pulmonary disease (COPD) is a progressive respiratory disease associated with respiratory muscle weakness and activity-limiting symptoms such as dyspnea. Respiratory muscle strength training (RMST) is an empirically validated therapy to increase respiratory muscle strength. The theoretically-informed, technology-enhanced RESP-FIT intervention for COPD is a 6-week combined inspiratory and expiratory muscle strength training program with symptom measurement in real time via ecological momentary assessment (EMA). In addition to hypothesis generating purposes, the purpose of this randomized control pilot study was to explore whether observed effects (on symptoms, patient-reported outcomes, and respiratory muscle strength) support carrying out a future large-scale trial of RESP-FIT. Thirty adults with COPD were randomized to intervention (n=15) or control, with intervention group undergoing 6 weeks of mHealth-enhanced RMST. Daily symptom data were collected in real time over the 6-week intervention period using EMA. Compared to the control group, participants in the intervention group reported decreased dyspnea and anxiety, increased happiness, and improved respiratory muscle strength (PIMax). However, reports of fatigue and sleep disturbance increased in the intervention group compared to the control group. Results support the hypothesis that the 6-week RESP-FIT program will improve respiratory muscle strength, emotional state (anxiety and happiness), and breathlessness in COPD but may contribute to fatigue, at least in the short-term. Future work is needed to determine efficacy of RESP-FIT, determine mechanisms of action on dyspnea and fatigue, and conduct within-subject comparisons of EMA data to explore individual or environmental fluctuations in COPD symptoms.

TARGETING HEALTH-PROMOTING ACTIVITY IN OLDER ADULTS WITH MULTIPLE CHRONIC CONDITIONS AND FUNCTIONAL LIMITATIONS

Abstract Nearly half of older adults in the U.S. have multiple chronic health conditions in addition to functional limitations (MCC + FL) that restrict health self-management activities. We tested an innovative combination of occupational therapy (OT) and behavioral activation (BA) to improve health self-management using the goal setting, scheduling/monitoring activities, and problem-solving components of the BA approach, as well as skill building, environmental modification, activity adaptation, and focus on daily routines from OT (BA+OT). BA+OT was delivered by occupational therapists over 10 sessions in the homes of participants. We present descriptive statistics from this single-blind randomized control pilot study of 11 older adults with MCC + FL who received BA+OT (n = 6) or enhanced usual care (UC; n = 5). Participants in both groups were given a Fitbit, and the UC group received a handout on managing chronic conditions. The BA+OT group was required to set at least one goal for improving physical activity. On average, participants were 73.1 years old (SD = 8.4), majority female (n = 8), and white (n = 1 Hispanic/Latino). They had an average of 3.9 chronic conditions (SD = 1.5), and 2.0 functional limitations (SD = 1.8). The most common chronic conditions were depression, high blood pressure, and arthritis. Aside from physical activity, the most common participant-identified goal areas were sleep hygiene and positioning, medication routines, and community access. This study is in progress (aiming for n = 40) but shows promise for improving health self-management by targeting meaningful, goal-directed, and health-promoting daily activity.

Clinical and Radiographic evaluation of bone remodeling around implants placed in horizontally augmented bone: A Pilot Study

Introduction: Marginal bone loss after implant placement is one of the most used criteria to assess the success of osseointegrated implants over time. The type of implant connection and implant surface type are reported to have an influence on bone remodeling around the placed implants. This study aimed to evaluate marginal bone loss around two implant systems with different connections and surfaces in horizontally augmented sites. Methods: This randomized control pilot study included 8 implants placed in 3 patients who needed implant placement in previously horizontally grafted sites. The placed implants were divided into two groups: group 1 consisting of implants with external connection and a hybrid design, and group 2 including implants with an internal connection and a fully etched surface. Clinical and radiographical measurements were taken at baseline, during the surgery, and up to one year after loading to evaluate marginal bone loss around the two different implants placed in grafted sites. Results: All implants were retained at all follow-up periods and healing was uneventful. There were similar Marginal Bone Loss (MBL) and soft tissue changes around both types of implants. Group 2 implants had higher MBL, however, the difference was not statistically significative. Conclusions: Preliminary analysis suggest that full surface etching does not seem to negatively influence marginal bone loss around implants placed in augmented bone.

Investigating the mood effects of nature sounds and soothing images in adolescents: A proof-of-concept randomised control pilot study

Background: High prevalence of mental health problems in adolescents indicates a need for more accessible evidence-based interventions. Connection with nature and soothing imagery based on compassion focused therapy (CFT) have both been shown to offer mood benefits, with a recent study showing that both nature related sounds and soothing images were effective in reducing negative affect and depressive mood in adults. This pilot study aimed to extend this line of research by examining whether nature related sounds and soothing images could, independently and/or collectively, improve adolescents’ mood. Methods: Our online study included 88 adolescents, aged 13-17, randomly allocated into one of three experimental conditions (viewing soothing images, listening to nature related to sounds, or combined). They also completed pre- and post-assessments of positive affect, negative affect, serenity affect, state anxiety and state depression. Symptoms of depression and anxiety were indexed at baseline using standardised self-reported measures. Results: Adolescents, regardless of group, reported an increase in serenity affect and a reduction in negative mood states across time. Additionally, these mood changes appeared to be more pronounced in those with higher levels of anxiety and depressive symptoms at baseline. Conclusions: Our findings provide preliminary evidence that, upon further research development and replication, nature related sounds and soothing images could be incorporated into therapies such as CFT to support mental health in young people. Registration: ISRCTN16916695.

Quality of life amongst patients with diverting umbilical stomas in rectal surgery: a single centre prospective randomized controlled pilot study.

The umbilical stoma (umbistoma) has been proposed as a viable alternative site for a temporary defunctioning stoma. Suggested advantages of the umbistoma include decreased number of surgical incisions required, improved cosmesis and ease of reversal surgery. This study aimed to assess the patient experience of umbilical loop ileostomies in rectal surgery, with the primary outcome being patient reported quality of life (QoL). A total of 20 patients undergoing laparoscopic rectal cancer surgery were randomly allocated to have a defunctioning ileostomy at a conventional site (right iliac fossa) or at the umbilicus. Patient-reported QoL was assessed at 6 weeks using the Stoma-QoL questionnaire. Secondary outcomes were number of stomas reversed, length of time awaiting stoma reversal surgery, duration of operative time for stoma reversal, length of hospital stay following stoma reversal and rate of parastomal or post reversal incisional hernias. Patients who had an umbilical stoma scored significantly lower on the Stoma-QoL questionnaire compared to the conventional group, particularly on questions regarding feelings of tiredness, body insecurity and anxiety. No significant differences were observed between the two groups in relation to secondary outcomes. There may be potential disadvantages to the umbilical stoma with negative impacts on body image and subsequent increased social anxiety. Patient selection and adequate counselling will be important when considering an umbilical stoma. Further larger scale prospective studies are required to further validate the feasibility and longer-term safety of umbilical stomas in both clinical outcomes as well as patient QoL.

Implementation of an Online Family-based Intensive Healthy Lifestyle Behaviour Intervention (LITE Programme): Randomised Controlled Pilot Study

Implementation of an Online Family-based Intensive Healthy Lifestyle Behaviour Intervention (LITE Programme): Randomised Controlled Pilot Study

Computer-assisted intraoperative 3D-navigation for liver surgery: a prospective randomized-controlled pilot study.

Liver surgery is the standard of care for primary and many secondary liver tumors. Due to variability and complexity in liver anatomy preoperative imaging is necessary to determine resectability and for planning the surgical strategy. In the last few years, computer-assisted resection planning has been introduced in liver surgery. Aim of this trial was the evaluation of computer-assisted three-dimensional (3D)-navigation for liver surgery. This study was a prospective randomized-controlled pilot trial and patients were randomized in navigated or non-navigated group. Primary end point was the quotient of intraoperative resected volume and planned resection volume. Secondary end points included operation time, resection margin and postoperative complications. 3D reconstructions were performed with MeVis Distant Services (MeVis AG, Bremen, Germany). The navigation system CAS-One Liver (CAScination AG, Bern, Switzerland) was used for intraoperative computer-assisted 3D-navigation. The data of 16 patients with 20 liver tumors were used in this analysis. Of these, 8 liver tumors were resected with the utilization of intraoperative navigation. Two postoperative complications were classified grade IIIa or higher. There was no difference in duration of operation (189 vs. 180 min, P=0.970), rate of postoperative complications (n=1 vs. n=1, P=0.696) and length of hospital stay (9 vs. 7 days, P=0.368) between the two groups. Minimal resection margin (0.15 vs. 0.40 cm, P=0.384) and quotient of planned to intraoperative resection volume (0.94 vs. 1.11, P=0.305) were also similar. Intraoperative navigation is a technology that can be safely used during liver resection. Surgical accuracy is not yet superior to the current standard of intraoperative orientation. Further technological advances with suitable deformation algorithms and augmented reality systems will enable a further improvement of the technical feasibility.

The Effects of Lakitelek Thermal Water and Tap Water on Skin Microbiome, a Randomized Control Pilot Study

The beneficial effects of balneotherapy have been proven by numerous clinical studies on locomotor disorders. To date, there is only scant data on changes in the microbiome system of the skin during balneotherapy. The aim of this study was to compare the effects of thermal water and tap water on the skin's microbiome in healthy volunteers. 30 healthy female volunteers participated in the study. The experimental group (of 15 women) spent 30-min 10 times, in Gabriella Spring's thermal baths (i.e., mineral water containing sodium hydrogen carbonate).The controlled group (15 women) had the same, but in tap water. The results of this study have proven that there is a difference in the influencing effects of tap water and medicinal water on the microbiome of the skin. After bathing in the thermal water of Lakitelek, Deinococcus increased significantly at the genus level, and the tendency for Rothia mucilaginosa bacteria also increased. At the species level, Rothia mucilaginosa increased significantly, while Paracoccus aminovorans and the tendency for Paracoccus marcusii decreased. When the values of the two trial groups after bathing at the genus level were compared, Rothia bacteria increased significantly, while Haemophilus tended to increase, Pseudomonas tended to decrease, Neisseria tended to increase significantly, and Flavobacterium tended to decrease. At the species level, Geobacillus vulcani decreased significantly, and the tendency for Burkholderia gladioli decreased. The growth of Rothia mucilaginosa and the decrease in the tendency of Paracoccus, Pseudomonas, Flavobacteroium, and Burkholderia gladioli confirm the beneficial effect of balneotherapy. In this study, trends are represented by the uncorrected p value. The main result was that the thermal water changed certain bacteria of the skin, both on the genus and species levels, but there were no significant changes in the tap water used, either at the genus or species level. We first compared the worlds of thermal water and tap water's microbiome systems. The thermal water decreased the number of certain inflammatory infectious agents and could enhance some of their positive effects, which have been proven at the molecular level. Our results can provide an important clue in the treatment of certain skin diseases. The research of the skin microbiome during balneotherapy can be one of the most intriguing and exciting topics of the future and can bring us closer to understanding the mechanism of action of balneotherapy.

Effects of a training intervention tailored to the menstrual cycle on endurance performance, recovery and well-being in female recreational runners – A randomized-controlled pilot study

Effects of a training intervention tailored to the menstrual cycle on endurance performance, recovery and well-being in female recreational runners – A randomized-controlled pilot study

Delivering the Thinking Healthy Programme as a universal group intervention integrated into routine antenatal care: a randomized-controlled pilot study

BackgroundWomen with perinatal depression and their children are at increased risk of poor health outcomes. There is a need to implement non-stigmatizing interventions into existing health systems which reduce psychosocial distress during pregnancy and prevent perinatal depression. We adapted the WHO-endorsed Thinking Healthy Programme (THP) to be delivered universally to all women attending routine online pregnancy schools in Istanbul, Turkey. This study aimed to evaluate the feasibility and acceptability of this intervention.MethodsThis mixed-methods study incorporated a two-arm pilot randomized controlled trial and qualitative evaluation of the feasibility and acceptability of the adapted THP – Brief Group version (THP-BGV) to a range of stakeholders. We recruited pregnant women at 12-30 weeks’ gestation through pregnancy schools within the University Hospital’s catchment area. Women in the intervention arm received five online sessions of the THP-BGV delivered by antenatal nurses. The intervention employed principles of cognitive behaviour therapy to provide psychoeducation, behaviour activation, problem-solving strategies and group support to participants. In the control arm, women received usual care consisting of routine online educational pregnancy classes aided by the antenatal nurses. The women were assessed for depressive symptoms with the Edinburgh Postnatal Depression Scale at baseline and 4-6 weeks post-intervention and also evaluated for anxiety, perceived social support, partner relationship, level of disability and sleep quality. In-depth interviews were conducted with women and other key stakeholders.ResultsOf the 99 consecutive women referred to the pregnancy schools, 91 (91.9%) were eligible and 88 (88.8%) consented to participate in the study and were randomized. Eighty-two (83%) completed the final assessments. Our main findings were that this preventive group intervention was feasible to be integrated into routine antenatal educational classes and it was valued by the women and delivery-agents. While the study was not powered to detect differences between intervention and control conditions, we found small trends towards reduction in anxiety and depressive symptoms favoring the intervention arm. No serious adverse events were reported.ConclusionsGiven the paucity of preventive interventions for perinatal depression in low and middle-income countries, a fully powered definitive randomized controlled trial of this feasible and acceptable intervention should be conducted.Trial registrationThe study was registered at Clinical Trails.gov (NCT04819711) (Registration Date: 29/03/2021).

The Impact of the FertiStrong Mobile Application on Anxiety and Depression in Men: A Randomised Control Pilot Study.

Male factor accounts for up to half of all cases of infertility. Previously, research has focused on the psychological effects of infertility on female partners, but recent studies show negative consequences on male patients as well. Despite evidence that men are affected by infertility, there is limited studies focusing on coping methods for them. Determine if a cognitive-behavioral and relaxation mobile application, targeted at men experiencing infertility, could lead to decreases in psychological distress. Randomized controlled. Thirty-nine men participated in a randomized pilot study of the FertiStrong application. Participants completed a demographic form, the Hospital Anxiety and Depression Scale (HADS) and Fertility Problem Inventory (FPI) at baseline and one month follow-up. The intervention group downloaded the FertiStrong application and used it when needed. Control participants received routine infertility care. Normally distributed data is presented as mean+/- SD; Differences in proportions were tested using Chi-square test and within group comparison were performed using paired t-test. One participant was excluded, resulting in 38 participants, 19 in each group. There were no baseline differences in demographic characteristics (P>0.31). For the HADS anxiety domain, the control group had a small increase between baseline and follow up, while the intervention group had a small decrease. For the HADS depression domain, there was a slight increase in the controls. For the FPI, the control group had a two-point increase, from moderately stressed to extremely high while the intervention group had a five-point decrease, from extremely high to moderately high, but was not significant. Each FPI domain-specific score in the intervention group decreased and one, Rejection of Childfree lifestyle, was significant (P=0.03). The increase in stress level was significantly greater in the control group (P<0.02). Recruitment was challenging due to the short recruitment phase and the sample size was smaller than planned. However, there were several significant improvements noted in the intervention group and on all testing, the intervention group trended to less distress. More research is needed on convenient interventions for men experiencing infertility.