Single-blind Randomized Clinical Trial Research Articles

Rationale and Design of a Multicenter Trial on Exploratory Analysis of the Effects of Advance Care Planning Guided by the Prediction Program of Heart Failure Prognosis on Quality of Life in Patients With Heart Failure - ACQUAINT-Trial.

Background: Preplanning of care is necessary for patients with endstage heart failure (HF), but advance care planning (ACP) before the loss of a patient's comprehensive capacity is not yet routine for the public or the medical community. The challenge in accurately predicting a patient's prognosis is a strong barrier to implementing ACP. To address this problem, several models for risk stratification have been proposed and are available in clinical settings. Methods and Results: We randomized the procedure to provide estimated patient survival information to attending physicians and then assessed whether there was a change in (1) the frequency of ACP initiation occurred (physician-side evaluation), and/or (2) the patients' quality of life, including mental state (patient-side evaluation). Conclusions: This multicenter, open-label, single-blinded randomized clinical trial aims to assess the hypothesis that providing information on the estimated survival of a patient to the attending physicians will improve the frequency of ACP initiation and quality of life in patients with HF.

Effectiveness of simultaneous bilateral visual diaphragm biofeedback under low back pain: influence of age and sex

Introduction: The aim of the present study was to determine the effectiveness of simultaneous bilateral visual diaphragm biofeedback (BFB) from ultrasonography in conjunction with inspiratory muscle training (IMT) on diaphragmatic thickness during normal breathing and respiratory and clinical outcomes in patients with non-specific low back pain (NSLBP) and determine the influence of age and sex.Methods: A single-blind randomized clinical trial was carried out (NCT04582812). A total sample of 96 patients with NSLBP was recruited and randomized by sex-based stratification into IMT (n = 48) and BFB + IMT (n = 48) interventions over 8 weeks. Bilateral diaphragmatic thickness at maximum inspiration (Tins) and expiration (Texp), respiratory pressures, lung function, pain intensity, bilateral pressure pain threshold (PPT), disability, and quality of life were measured at baseline and after 8 weeks.Results: The BFB + IMT group showed significant differences (p < 0.05) with increased left hemidiaphragm thickness at Tins and Tins-exp (d = 0.38–053), and right and left PPT (d = 0.71–0.74) versus the IMT group. The interaction with sex was statistically significant (p = 0.007; F(1,81) = 7.756; ηp2 = 0.087) and higher left hemidiaphragm thickness at Tins was predicted by the BFB + IMT group (R2 = 0.099; β = 0.050; F(1,82) = 8.997; p = 0.004) and male sex (R2 = 0.079; β = 0.045; F(1,81) = 7.756;p = 0.007). Furthermore, greater left hemidiaphragm thickness at Tins-exp was predicted by younger age (R2 = 0.052; β = −0.001; F(1,82) = 4.540; p = 0.036).Discussion: The simultaneous bilateral visual diaphragm biofeedback by ultrasonography in conjunction with IMT was effective in both increasing the left diaphragmatic thickness during inspiration, which was positively influenced and predicted by male sex and younger age, and increasing the bilateral PPT of the paraspinal muscles in patients with NSLBP.

Evaluation of the Effect of Benzydamine Hydrochloride on the Intensity of Gag Reflex: A Randomized Single-Blind Clinical Trial.

Gag reflex is among the most common problems during dental and endoscopic procedures. Benzydamine hydrochloride is a non-steroidal anti-inflammatory medication and a local anesthetic that might be useful in reducing the gag reflex. This study aimed to evaluate the effects of benzydamine hydrochloride mouthwash on the intensity of the gag reflex. In this randomized clinical trial study, 30 participants aged 21-26 with a gag trigger point index (GTPI) higher than 2 were divided into 2 groups. In the case group, 15 ml of 0.15% benzydamine hydrochloride mouthwash was gargled for 1 minute, and after 10 minutes GTPI test was conducted. In the control group, 4 puffs of 10% lidocaine spray were applied to the mucosa of the targeted area, and after 5 minutes, GTPI was measured. Participants were asked about the taste and smell of the medications. GTPI was significantly reduced in both groups. In the lidocaine group, the GTPI score changed from 4.47 to 2.00 (p< 0.001), and that for the benzydamine group was 4.20 to 1.47 (p< 0.001). The variance rate of the gag reflex was -2.73 and -2.47 in the benzydamine group and lidocaine group, respectively. However, this reduction was not statistically significant between the two groups. Moreover, benzydamine mouthwash has a significantly better taste and smell than lidocaine (p= 0.001). The results of this study showed that benzydamine mouthwash could be used quite effectively in reducing the gag reflex.

Effects of ketamine on the severity of depression and anxiety following postoperative mechanical ventilation: a single-blind randomized clinical trial in Iran.

In this study, we compare the effects of ketamine and the combination of midazolam and morphine on the severity of depression and anxiety in mechanically ventilated patients after discharge from the intensive care unit (ICU). This randomized single-blind clinical trial included 50 patients who were candidates for craniotomy and postoperative mechanical ventilation in the ICU of 5 Azar Teaching Hospital in Gorgan City, North Iran, from 2021 to 2022. Patients were allocated to two groups by quadruple block randomization. In group A, 0.5 mg/kg of ketamine was infused over 15 minutes after craniotomy and then continued at a dose of 5 µ/kg/min during mechanical ventilation. In group B, midazolam was infused at a dose of 2-3 mg/hr and morphine at a dose of 3-5 mg/hr. After patients were discharged from the ICU, if their Glasgow Coma Scale scores were ≥14, Beck's anxiety and depression inventories were completed by a psychologist within 2 weeks, 2 months, and 6 months after discharge. The mean scores of depression at 2 months (P=0.01) and 6 months (P=0.03) after discharge were significantly lower in the ketamine group than in the midazolam and morphine group. The mean anxiety scores were significantly lower in the ketamine group 2 weeks (P=0.006) and 6 months (P=0.002) after discharge. Ketamine is an effective drug for preventing and treating anxiety and depression over the long term in patients discharged from the ICU. However, further larger volume studies are required to validate these results.

Evaluation of anchorage loss after en masse retraction in orthodontic patients with maxillary protrusion using friction vs frictionless mechanics: randomized clinical trial

ABSTRACT Objectives To evaluate anchorage loss after en masse retraction in bimaxillary dentoalveolar protrusion patients using friction vs frictionless mechanics. Materials and Methods Thirty patients with bimaxillary dentoalveolar protrusion needing extraction of upper first premolars and en masse retraction with maximum anchorage were included in this two-arm, parallel, single-center, single-blinded randomized clinical trial with a 1:1 allocation ratio using fully sealed opaque envelopes. Friction group retraction utilized elastomeric power chain between miniscrews and hooks crimped mesial to upper canines on 17 × 25 stainless steel archwire. Frictionless group used customized T-loop springs loading upper first molars indirectly anchored to miniscrews. Activation was every 4 weeks until full retraction. The primary outcome assessed was anchorage loss evaluated at cusp tip and root apex of the first molar. First molar rotation, incisor tip and torque, and root resorption of anterior teeth were evaluated on digital models and cone beam computed tomography taken before and after space closure. Results Anchorage loss at crown of first molar was significantly more in frictionless group by 2.1 mm (95% CI = −0.4 to 3.5), (P = .014), while there was no significant difference in anchorage loss at root apex between groups. Significant mesial in molar rotation of 6.672° (95% CI = 12.2–21.2), (P = 0.02) was greater in the frictionless group. Both groups showed comparable tip, torque, and root resorption values. No severe harms were reported. There was mild gingival overgrowth and inflammation in the frictionless group due to T-loop irritation. Conclusions Extra anchorage considerations are needed during en masse retraction when frictionless mechanics is implemented as higher anchorage loss and molar rotation were detected. No difference in tip, torque, and root resorption was observed.

The impact of combined administration of surfactant and intratracheal budesonide compared to surfactant alone on bronchopulmonary dysplasia (BPD) and mortality rate in preterm infants with respiratory distress syndrome: a single-blind randomized clinical trial

BackgroundRespiratory distress syndrome (RDS) is one of the most important and common disorders among premature infants.ObjectiveThis study aimed to compare the effect of the combination of surfactant and budesonide with surfactant alone on Bronchopulmonary dysplasia (BPD) and mortality rate among premature infants with RDS.MethodAn outcome assessor-blind randomized clinical trial was conducted on 134 premature infants with RDS who were born in Ayatollah Mousavi Hospital, Zanjan, Iran in 2021. The covariate adaptive randomization method was utilized to allocate participants into two groups (surfactant alone and a combination of surfactant and budesonide). The primary outcomes were BPD and Mortality rate from admission to hospital discharge. The data in this study were analyzed using SPSS software version 18.ResultsOverall the comparison of mortality rate and BPD between the two groups did not show a significant difference(p > 0.05). The subgroup results showed that administering surfactant with budesonide to infants under 30 weeks of age significantly reduced the number of deaths compared to using surfactant alone (5 vs. 17). Similar positive effects were observed for the occurrence of Pulmonary Hemorrhage, the need for a second dose of surfactant, oxygen index, mean blood pressure and mean arterial pressure (MAP) in infants under 34 weeks of age compared to more than 34 weeks (p < 0.05).ConclusionThese findings suggest that the combination therapy of surfactant and budesonide may be beneficial, particularly in preterm infants with less than 34 weeks gestational age and 1500 birth weight. However, further studies with larger sample sizes and longer follow-up periods are needed to confirm these results and assess long-term outcomes.Trial registrationThe study was registered at the Iranian Registry of Clinical Trials website under the code IRCT20201222049802N1. https://en.irct.ir/user/trial/48117/view.Registration date28/02/2021.Public repository: Data setThis research data set link is displayed on the Zanjan-Iran Medical Sciences website: https://repository.zums.ac.ir/cgi/users/login? target=https%3 A%2 F/repository.zums.ac.ir/id/eprint.

Evaluation of mucin changes between daily and extended wear silicone hydrogel contact lenses

Background: Initially, contact lenses were recommended only for daily wear because of infection and discomfort concerns. With rising demand, particularly for overnight use, extended wear lenses have gained significance. Despite concerns, intensive development of materials like Lotrafilcon B aims to meet this demand, focusing on comfort and safety.Aim: This study aimed to evaluate the mucin quantity and quality changes between daily and extended wear (Lotrafilcon B), impacting eye health and comfort.Setting: The study was conducted at Kirana Eye Center, Cipto Mangunkusumo Hospital, Jakarta, Indonesia.Methods: This study was a single-blinded randomised clinical trial with two parallel groups. Forty (40) eligible subjects willingly participated. Mucin 5AC (MUC5AC) and Ferning-type tests were conducted. The 40 subjects with moderate myopia were then divided into a daily wear and an extended wear group. The MUC5AC test was performed at pre-fitting and at 4 weeks, whereas the Ferning-type tests were taken at pre-fitting and 1st and 4th weeks.Results: For both groups, there was a significant increase in MUC5AC levels from pre-fitting to week four, but with no significant difference between them in final MUC5AC levels. Additionally, the comparison of eyes with normal and abnormal Ferning-types between the two groups showed no significant differences at pre-fitting, 1st and 4th weeks.Conclusion: There is no significant difference in MUC5AC levels with the use of daily or extended wear (with Lotrafilcon B).Contribution: This study compares the impact of daily and extended wear Lotrafilcon B contact lenses on eye health and comfort in moderate myopia patients.

Comparative Evaluation of the Effect of Photobiomodulation on Pain Reduction in Individuals Undergoing Segmental Retraction Using a Closing Loop: A Randomized Controlled Clinical Trial.

Pain following orthodontic treatment is a common reason for apprehension and treatment discontinuation. Research on modalities to control pain in orthodontic patients has gained special attention. Low-level laser therapy (LLLT) is studied as an alternative pain management modality free of the adverse effects of analgesic medications. This study evaluated the effectiveness of photobiomodulation therapy (PBMT) for pain control following the activation of a closing loop for canine retraction. This is a split-mouth, placebo-controlled, single-blinded randomized clinical trial that evaluated 16 patients who need canine retraction using closing loops. Two maxillary quadrants were allotted into test and control groups using the coin toss method. In the test group, a low-intensity laser with 810 nm wavelength for 60 seconds in pulsated non-contact mode was used in the buccal, palatal, mesial, and distal regions of the canine immediately after activating the loop. The control site received placebo radiation. The pain level was recorded 2, 24, 48, and 72 hours afterintervention in thecontrol and test groups using the Visual Analogue Scale (VAS). The test and control groups were compared usingStudent's t-test. A p-value ≤0.05 was considered statistically significant. Analyses were conducted using IBM SPSS Statistics for Windows, Version 25.0 (Released 2017; IBM Corp., Armonk, New York, United States). Both groups had a significant statistical difference in the pain score. The laser group showed a statistically significant lower pain scorecompared to the control group at all time points. Photobiomodulation by810 nm 300 mW diode laser can effectively reduce pain following the retraction of maxillary canines.

Virtual reality-based cognitive–behavioural therapy for the treatment of anxiety in patients with acute myocardial infarction: a randomised clinical trial

BackgroundThe presence of mental health conditions is pervasive in patients who experienced acute myocardial infarction (AMI), significantly disrupting their recovery. Providing timely and easily accessible psychological interventions using virtual reality-based...

Platelet-rich plasma as a new and successful treatment for lichen planopilaris: A controlled blinded randomized clinical trial.

Lichen planopilaris (LPP) is one of the most common causes of scarring hair loss caused by immune-mediated inflammation resulting in atrophy and scaling. The key to preventing this irreversible hair loss is diagnosing and starting treatment at the earliest possible stage. As there is no definite cure for LPP, the therapy could be challenging. In the study, we conducted a single-blinded randomized clinical trial to evaluate the therapeutic effects, safety, and tolerability of platelet-rich plasma versus topical clobetasol in the treatment of LPP. A randomized single-blinded controlled clinical trial was conducted in 24 LPP patients referring to our dermatology clinic between August 2022 and March 2023. Patients in the control group were treated with topical clobetasol 0.05% applied at night, and patients in the case group, in addition to topical clobetasol, received three sessions of PRP injection monthly. Both groups were assessed 1, 2, and 6 months after the start of the study by the Lichen Planopilaris Activity Index (LPPAI), physician and patient satisfaction, tolerability, and recording adverse effects. The average age in the clobetasol and PRP groups was 43.75 ± 13.51 and 42.75 ± 9.67, respectively (p = 0.83). In terms of gender, all 12 cases (100%) in the clobetasol group and 9 cases (75%) in the PRP group were female (p = 0.21). Both PRP and topical clobetasol effectively reduced LPPAI in the first 2 months; however, after 6 months, the LPPAI significantly increased in the clobetasol group (p = 0.001). There were no significant differences in LPPAI between the two groups at the beginning of the study and after 1 month. However, the mean LPPAI score in the clobetasol group was significantly higher than in the PRP group at 2 and 6 months after the start of the study (p = 0.01). Patient satisfaction with treatment increased in both groups during follow-up sessions, but at the end of the follow-up period, it was significantly higher in the PRP group (p = 0.03). Finally, the study did not have any serious adverse effects, and the pain experienced during PRP injection was tolerable for the patients. Overall, treatment tolerability was excellent in both groups. Given the different efficacy profiles, PRP could be considered a new and effective choice for the treatment of LPP.

Telephone-Based Rehabilitation Intervention to Optimize Activity Participation After Breast Cancer

Following treatment, breast cancer survivors face challenges participating in valued activities. To determine whether a telephone-based coaching rehabilitation intervention enhances activity participation in the year following breast cancer treatment. In this multisite, single-blind randomized clinical trial (Optimizing Functional Recovery of Breast Cancer Survivors), recruitment occurred between August 28, 2019, and April 30, 2022. Data collection was completed by April 1, 2023. Participants were recruited from 2 cancer centers (Dartmouth College and the University of Alabama at Birmingham) and via social media advertisements. Women aged 18 years or older who had completed primary treatment for stage I to III breast cancer within 1 year and reported participation restrictions were eligible to participate. Randomization was stratified by site, treatment, and time since treatment. The intervention, delivered via telephone over 9 sessions, used behavioral activation and problem-solving principles to promote activity participation. The education-based attention control condition was delivered via telephone at matched intervals. The primary outcome was participation, assessed using 5 measures, including Patient-Reported Outcomes Measurement Information System (PROMIS) social participation-satisfaction measure. One individualized outcome allowed participants to specify activities for which they wanted to foster recovery. Outcomes were collected by telephone by blinded coordinators at baseline and at 8, 20, and 44 weeks. The individualized outcome was assessed at the first and last intervention and control session. Among 1996 patients identified, 303 were eligible and enrolled. Of these, 284 women (94%; mean [SD] age, 56.1 [10.2] years) completed baseline assessments and were randomized, and 81% or more of each group completed the final assessment with no adverse events. Of those who completed the final assessment, 118 of 114 (82%) were in the intervention group, and 113 of 140 (81%) were attention control participants. Between-group differences were not statistically significant for the main measures of PROMIS satisfaction (week 20: Cohen d, 0.1 [95% CI, -0.09 to 0.29] and week 44: Cohen d, -0.08 [95% CI, -0.27 to 0.11]) and ability (week 20: Cohen d, 0.15 [95% CI, -0.06 to 0.37] and week 44: Cohen d, -0.08 [95% CI, -0.27 to 0.11]). On the individualized outcome, intervention participants reported significantly greater improvements in activity satisfaction (Cohen d, 0.76 [95% CI, 0.48-1.02]) and performance (Cohen d, 0.60 [95% CI, 0.32-0.87]). In this randomized clinical trial, the intervention catalyzed greater improvements in self-selected activity participation and goal disengagement but did not otherwise accelerate recovery compared with the control condition. Future research should determine what intervention features may lead to the greatest reductions in participation restrictions and other measures that may detect functional recovery. ClinicalTrials.gov Identifier: NCT03915548.

Lidocaine Needling in Myofascial Pain Syndrome for Palliative Oncologic Care: A Randomized Clinical Study.

Background: Physical pain is highly prevalent and impacts the well-being of patients with advanced oncologic disease. Although myofascial pain syndrome (MPS) can be one of the components of pain in cancer patients on palliative care (PC), so far there is no evidence about the benefit of treatment with 1% lidocaine needling. Objectives: To evaluate the efficacy of MPS treatment with injection of 1% lidocaine on the reduction of pain in cancer patients on PC. Design: Single-blind randomized clinical trial. Subjects: Patients aged 50 years or older with end-stage cancer, admitted to a cancer ward or monitored during radiotherapy in three Brazilian hospitals, with a diagnosis of MPS with a pain intensity of five or more according to the Visual Analog Scale (VAS). The patients were divided into two groups: trigger point (TP) injection with 1% lidocaine and control. Measurements: Pain intensity was assessed with the VAS, pain threshold with an algometer, and the medications being used were determined before and 72 hours after the intervention. Results: Thirty patients (15 per group) were assessed. After 72 hours, there was a reduction in referred pain intensity (p < 0.001) and an increase in pressure threshold (p = 0.007) in the intervention group (IG), with no difference in the control. The frequency of individuals who reduced the doses and/or classes of pain medications was higher in the IG (p = 0.011). Conclusion: One percent lidocaine needling in TPs was an effective therapy for pain reduction in MPS.

Comparing semi-recumbent lateral position vs semi-recumbent position in preventing VAP and ARDS in traumatic brain injury patients requiring mechanical ventilation

Background and aimsVentilator-associated pneumonia is a common nosocomial infection in the intensive care unit among traumatic brain injury patients, resulting in increased morbidity and mortality. We have assessed the effectiveness of semi-recumbent lateral positioning in comparison with semi‐recumbent positioning to prevent ventilator-associated pneumonia and acute respiratory distress syndrome in traumatic brain injury patients requiring mechanical ventilation. MethodsIn a single-blind prospective randomised clinical trial, 100 patients were recruited in the intensive care unit and randomly assigned to the control group (n = 50) and intervention group (n = 50). Patients in control group maintained semi-recumbent position with 30–45° head of bed elevation and intervention group maintained semi-recumbent lateral position with lateral turning ≥45° and head of bed elevation 30–45° every 4 h. Bronchoalveolar lavage for diagnosis of ventilator-associated pneumonia, Glasgow Coma Score, clinical pulmonary infection score, duration of mechanical ventilation, PaO2/FiO2 ratio and incidence of acute respiratory distress syndrome were investigated for 10 days. ResultsComparing semi-recumbent position with semi-recumbent lateral position, the latter showed significant decrease in ventilator-associated pneumonia with lower clinical pulmonary infection score at day 3 (6.5 ± 2.9; 1.8 ± 2.1; p < 0.001), day 7 (6.6 ± 2.6; 2.6 ± 2.3; p < 0.001) and day 10 (7.7 ± 2.9; 2.3 ± 2.3; p = 0.001) and decreased incidence of positive bronchoalveolar lavage cultures at day 3 (p = 0.02), day 7 (p < 0.001) and day 10 (p = 0.001). Duration of mechanical ventilation was significantly reduced at day 7 (p = 0.04) and day 10 (p < 0.001). The incidence of acute respiratory distress syndrome was not different. ConclusionSemi-recumbent lateral position results in significant less incidence of ventilator-associated pneumonia and reduced duration of mechanical ventilation. Trial registration numberICMR-NIMS CTRI/2019/01/016829.

Effect of Intravenous Vitamin C on Serum Level and Urinary Excretion of Methadone in Patients with Methadone Poisoning: A Randomized Single-Blind Clinical Trial

Background: Methadone poisoning intentionally or accidentally leads to a high rate of treatment burden and cost and deaths. The evaluation of the factors affecting the severity of poisoning can reduce recovery time, costs, and potential risks. Objectives: This study aimed to investigate the effect of intravenous vitamin C (ascorbic acid) administration on serum level and urinary excretion of methadone. Patients and Methods: In this single-blind study, 54 patients who were diagnosed with methadone poisoning were divided into three groups. The two intervention groups received different doses of vitamin C, including 12 and 24 g, and the control group received normal saline. The serum methadone level and urine pH were measured at the time of arrival and 24 hours after admission. The data were analyzed using repeated measure analysis of variance (ANOVA) in STATA version 12. Results: In this study, 18 patients were placed in each group. The three groups were not significantly different in basic variables, such as age, gender, and methadone dosage. Between and within-group comparison showed a significant decrease in the serum methadone levels over time after adjusting age, gender and methadone dosage (P &lt; 0.05). Post-hoc analyses revealed a significant difference in methadone reduction between 12 g of vitamin C and control groups (P = 0.04), and there was no significant difference between the control and 24 g of vitamin C groups (P &gt; 0.05). However, between and within-group comparisons showed no significant difference between the three groups in terms of urine pH (P &gt; 0.05). In addition, interaction was observed between intervention and time on serum methadone levels (P &lt; 0.001) and urine pH (P = 0.04) variables. Conclusions: Consuming 12 g of vitamin C further reduced the serum methadone level in patients with methadone poisoning. There was no effect on methadone urinary excretion in patients.

Demographic and clinical characteristics associated with failure of physical therapy in chronic low back pain: a secondary analysis from a randomized controlled trial.

The effect of physical therapy on pain and disability alleviation in patients with chronic low back pain (cLBP) has been demonstrated, but the risk factors for treatment failure remain unknown. To explore the associations of baseline demographic and clinical characteristics with treatment failure after physical therapy intervention for cLBP. A secondary analysis of a single-blind randomized clinical trial. A rehabilitation hospital. A total of 98 patients with cLBP completed the 12-month measurement. Patients were randomly grouped into 3-month therapeutic aquatic exercise or physical therapy modalities. The primary outcome was treatment failure, which was defined as a decrease in the numeric rating scale to less than 2.0 points at 12-month follow-up. Associations between baseline demographic and clinical characteristics with risk of treatment failure were assessed by logistic regressions. The pain intensity in the failure cases was alleviated after 3-month intervention but continuously increased at 6- and 12-month follow-up (P<0.05). Old age was significantly associated with an increased risk of treatment failure (adjusted OR 3.26, 95% CI 1.11-9.60). Compared with those receiving physical therapy modalities, the patients receiving therapeutic aquatic exercise had less risk of treatment failure (adjusted OR 0.19, 95% CI 0.08-0.47), and age (P=0.022) was a modifier for this association. Compared with younger ones, older patients with cLBP had a higher risk of treatment failure after physical therapy and gained a stronger benefit of long-term pain alleviation from therapeutic aquatic exercise. Therapeutic aquatic exercise is an effective therapy for cLBP and more helpful for preventing treatment failure than physical therapy modalities, especially for older patients.

Effects of Auriculo-Acupuncture on Sleep and Emotional Stress in Hispanic Immigrants: A Small Randomized Clinical Trial.

Objectives: To investigate whether Hispanic immigrants with sleep disturbance showed improvements with auriculo-acupuncture mediated by emotional stress. Design: Single-blind randomized clinical trial. Settings/Location: Community. Subjects: Sixteen Hispanic male (N = 4) and female (N = 12) volunteers. Interventions: Bi-weekly intervention for eight total treatments of National Acupuncture Detoxification Association (NADA) auriculo-acupuncture or sham. Outcome Measures: Emotional distress and sleep measures were completed Baseline, Mid- (four treatments), and Follow-up (eight treatments). Comparisons between Groups and within sessions using Mixed-Model ANOVA; linear regression assessed emotional stress and sleep association. Results: Significant within-subjects effect of Session (p's <.05) with significant differences Baseline/Mid-Way and Baseline/Final (p's <.05). Linear Regression showed significant positive associations at Baseline. Conclusions: Community auriculo-acupuncture may improve sleep and emotional stress in Hispanic immigrants.

Comparison of the Effects of Stretching and Splinting in Improving the Range of Motion and Functional Status for Prevention of Post-Burn Axillary Contracture

Background: Burn injuries often lead to severe complications, including axillary contractures, which can significantly restrict shoulder movement and impact quality of life. The rehabilitation strategies for managing post-burn axillary contractures, particularly stretching and splinting, have been the subject of much research, given their potential to improve shoulder range of motion and functional status. Objective: This study aims to compare the effects of stretching combined with splinting versus splinting alone on the range of motion and functional status in patients with post-burn axillary contracture, to determine the most effective treatment modality for preventing the development of contractures. Methods: A single-blinded randomized clinical trial was conducted at the Burn and Plastic Surgery Department of Mayo Hospital, Lahore, over six months. Forty patients aged 20-50 years with Type 1 to Type 3 axillary contractures and shoulder abduction ranging from 20 to 100 degrees were enrolled. Participants were randomly assigned to either Group A (stretching plus splinting) or Group B (splinting alone). Outcomes were measured using the Disabilities of Arm, Shoulder, and Hand (DASH) questionnaire and goniometry for shoulder motion range, before and after the interventions. Statistical analysis was performed using SPSS version 25, with paired and independent T-tests applied for within and between-group comparisons, respectively. Results: The stretching group demonstrated significant improvements in shoulder motion ranges: flexion (91.00 ± 19.97 to 98.75 ± 19.75, p&lt;0.000), extension (34.50 ± 12.13 to 41.85 ± 12.70, p&lt;0.000), abduction (94.50 ± 26.84 to 103.50 ± 25.97, p&lt;0.000), external rotation (34.15 ± 18.79 to 42.85 ± 18.87, p&lt;0.000), and internal rotation (33.95 ± 11.05 to 42.90 ± 11.03, p&lt;0.000). The DASH scores improved from 21.35 ± 3.58 to 31.30 ± 3.48 (p&lt;0.000). Similar improvements were noted in the splinting group but were more pronounced in the stretching group. Between-group analysis revealed significant differences in favor of the stretching group for all measures of shoulder motion and DASH scores. Conclusion: The study concluded that stretching, when combined with splinting, is more effective than splinting alone in improving shoulder range of motion and functional status in patients with post-burn axillary contracture. These findings suggest that incorporating stretching into the rehabilitation protocols for burn survivors could significantly enhance recovery outcomes.

Effect of Tai Chi vs Aerobic Exercise on Blood Pressure in Patients With Prehypertension

Prehypertension increases the risk of developing hypertension and other cardiovascular diseases. Early and effective intervention for patients with prehypertension is highly important. To assess the efficacy of Tai Chi vs aerobic exercise in patients with prehypertension. This prospective, single-blinded randomized clinical trial was conducted between July 25, 2019, and January 24, 2022, at 2 tertiary public hospitals in China. Participants included 342 adults aged 18 to 65 years with prehypertension, defined as systolic blood pressure (SBP) of 120 to 139 mm Hg and/or diastolic BP (DBP) of 80 to 89 mm Hg. Participants were randomized in a 1:1 ratio to a Tai Chi group (n = 173) or an aerobic exercise group (n = 169). Both groups performed four 60-minute supervised sessions per week for 12 months. The primary outcome was SBP at 12 months obtained in the office setting. Secondary outcomes included SBP at 6 months and DBP at 6 and 12 months obtained in the office setting and 24-hour ambulatory BP at 12 months. Of the 1189 patients screened, 342 (mean [SD] age, 49.3 [11.9] years; 166 men [48.5%] and 176 women [51.5%]) were randomized to 1 of 2 intervention groups: 173 to Tai Chi and 169 to aerobic exercise. At 12 months, the change in office SBP was significantly different between groups by -2.40 (95% CI, -4.39 to -0.41) mm Hg (P = .02), with a mean (SD) change of -7.01 (10.12) mm Hg in the Tai Chi group vs -4.61 (8.47) mm Hg in the aerobic exercise group. The analysis of office SBP at 6 months yielded similar results (-2.31 [95% CI, -3.94 to -0.67] mm Hg; P = .006). Additionally, 24-hour ambulatory SBP (-2.16 [95% CI, -3.84 to -0.47] mm Hg; P = .01) and nighttime ambulatory SBP (-4.08 [95% CI, -6.59 to -1.57] mm Hg; P = .002) were significantly reduced in the Tai Chi group compared with the aerobic exercise group. In this study including patients with prehypertension, a 12-month Tai Chi intervention was more effective than aerobic exercise in reducing SBP. These findings suggest that Tai Chi may help promote the prevention of cardiovascular disease in populations with prehypertension. Chinese Clinical Trial Registry Identifier: ChiCTR1900024368.

The Efficacy of Transverse Abdominal Plane Block with Bupivacaine Combined with Dexamethasone for the Management of Post-Caesarean Pain

Introduction: Caesarean section (CS) is a commonly performed major surgical procedure that causes significant postoperative pain. The objective of this study was to evaluate the efficacy of the transverse abdominal plane block (TAPB) in the management of post-caesarean pain at the Souro Sanou Teaching Hospital (CHUSS) of Bobo Dioulasso. Methodology: This was a single blind randomised clinical trial. One hundred patients admitted for CS under spinal anaesthesia were randomised into two groups using the sealed envelope method. The intrathecal morphine (ITM) group received 100 µg morphine intrathecally at induction and the TAPB group a bilateral TAPB at the end of the caesarean section with 20 ml of 0.25% bupivacaine and 4 mg dexamethasone in the same syringe on each side. The proportion of mild pain, numeric rating scale (NRS) &lt; 3 on mobilisation at 24 hours post-caesarean was the primary outcome. Results: The 2 groups were comparable for socio-demographic and clinical characteristics. The mean age of the patients was 28.14 ± 6.34 years and 29.08 ± 5.58 years (p=0.43). At rest at 24 hours post-op, the proportion of NRS &lt; 3 was 100% for the TAPB group and 88% for the ITM group (p=0.49). On mobilisation at 24 hours post-op, 96% of patients in the TAPB group and 74% in the ITM group (p=0.002) had a NRS &lt; 3. At rest at 48 hours post-op, it was 100% for the TAPB group and 88% for the ITM group (p=0.027). On mobilisation at 48 hours post-op, it was 94% for the TAPB group and 70% for the ITM group (p=0.002). Postoperative nausea and vomiting (PONV) were present in 50% of patients in the ITM group and 6% in the TAPB group (p&lt;0.001). Conclusion: TAPB significantly reduced pain scores on mobilisation in the post-caesarean period with a significant reduction in PONV.

Effects of 6-month customized home-based exercise on motor development, bone strength, and parental stress in children with simple congenital heart disease: a single-blinded randomized clinical trial

BackgroundNew “noncardiac” problems in children with congenital heart disease (CHD), such as developmental delay or long-term neurodevelopmental impairments, have attracted considerable attention in recent years. It is hypothesized that exercise might attenuate CHD-associated neurodevelopmental impairments; however, this has not been thoroughly investigated. The objective of this prospective, single-blinded, randomized controlled experiment was to evaluate the impact of customized home-based exercise for children with CHD.MethodsChildren aged 0–5 years with echocardiography-confirmed simple CHD subtypes who were scheduled to undergo cardiac catheterization were screened for enrolment. Among 420 screened CHD children, 192 were enrolled and randomly assigned at a 1:1 ratio to receive a 6-month intervention (30 min daily customized home-based exercise program with supervision for no less than 5 days per week, combined with home-based exercise education) or control treatment (home-based education). The primary outcome was motor development (gross motor quotient (GMQ), fine motor quotient (FMQ), and total motor quotient (TMQ)). The secondary outcomes were cardiac function and structure, bone quality, physical development, parental anxiety, caregiver burden, and quality of life. Children and their families were assessed before and 1, 3, and 6 months after catheterization; 183 (95.3%) children were included in the primary analysis.ResultsAfter 6-month treatment, the intervention group significantly increased their motor quotient, which was consistently higher than that of the control group (GMQ p < 0.0001, FMQ p = 0.02, TMQ p < 0.001). The physical developments in height, weight, and circumferences of the upper-arm, chest, and head were also significantly improved by exercise (all p < 0.017). No significant improvements in the bone strength or the cardiac structure and function were found among patients in the intervention group (all p > 0.017). For parents, higher quality of life level (total score p = 0.016) was observed in the intervention group; while effects of exercise on the anxiety (rude score p = 0.159, standard score p = 0.159) or the Zarit caregiver burden scale score (p = 0.404) were non-significant. No adverse events occurred during the study period.ConclusionsCustomized home-based exercise improved motor development in children with CHD. While the long-term effects of parent training in home-based exercise are unknown, the study results suggest positive outcomes.Trial registrationA home-based exercise program in congenital heart disease children with cardiac catheterization: a randomized controlled trial. (http://www.chictr.org.cn/, ChiCTR-IOR-16007762, January 14, 2016).