METHOD: The study followed a single-blind parallel group in a randomized controlled trial using an experimental longitudinal design, comprising 72 heterosexual couples living in Shiraz, Iran, with a 1-7-year marital age and no severe marital problems. The experimental group received eight consecutive O-GPIs via the Zoom platform, while the control group received information related to parenting skills via email. The outcome measures were the three patterns of communication: (i) constructive communication; (ii) demand-withdraw communication; and (iii) mutual avoidance communication-the screening measure was the dyadic adjustment scale.
RESULTS: The findings indicated that O-GPI could improve couples' constructive communication significantly (45% for husbands and 40% wives) and decrease their total demand-withdrawal (51% for husbands and 65% wives) and mutual avoidance communication (60% for husbands and 62% wives).
LIMITATIONS: Due to the homogenous nature of the sample, generalizations should be made with caution.
CONCLUSIONS: This study demonstrates the feasibility and effectiveness of the online Gottman's psychoeducational intervention to improve couples' communication patterns.
Methods: We used a single-blind, randomized controlled crossover equivalence design to compare the efficacy on N.A. regulation of W.A.R.A. versus Distraction in 101 patients with different neuropsychiatric disorders.
Results: The results showed a significant difference (p < 0.001) in response to W.A.R.A. vs. Distraction, with W.A.R.A. being significantly more effective in regulating N.A., with a large effect size (dRMpooled = 2.38) and a high probability (95%) of success.
Limitations: The heterogeneity of the study population makes generalization and clear recommendations for specific patient groups difficult. The Numeric Rating Scale might have prevented detection of increased N.A. when the baseline scores were high. More in-depth research is needed to explore the W.A.R.A. technique and the extent of confounding variables such as the placebo effect.
Conclusions: The findings suggest that W.A.R.A. may be an effective, accessible, and brief intervention reducing negative affect. Although premature, these first results are encouraging.
RESULTS: The GI of the calamansi drink tested was calculated as 37, a value within the range of low GI foods. Trial registration Clinical Trials identifier NCT04462016; Retrospectively registered on July 1, 2020.
METHOD: A single-blind cluster randomized controlled trial will conduct at six districts in Selangor. Randomly selected respondents who fulfilled the inclusion criteria will be invited to participate in the study. Health education module based on Health Believed Theory will be delivered via health talks and videos coordinated by liaison officers. Data at three-time points at baseline, immediate, and 3 months post-intervention will be collected. A validated questionnaire will assess participants' background characteristics, knowledge, skill, and preparedness on disaster preparedness and perception towards disaster. Descriptive and inferential statistics will be applied for data analysis using IBM Statistical Package for Social Sciences version 25. Longitudinal correlated data on knowledge, skills, preparedness, and perception score at baseline, immediate post-intervention, and 6 months post-intervention will be analyzed using Generalized Estimating Equations (GEE).
DISCUSSION: It is expected that knowledge, skills, preparedness, and flood disaster perception score are more significant in the intervention group than the control group, indicating the Health Education Based Intervention (HEBI).
TRIAL REGISTRATION: Thai Clinical Trial TCTR20200202002 .
OBJECTIVE: This study aims to develop, implement, and evaluate the effectiveness of Stop and Play, a digital parental health education intervention to reduce excessive screen time among preschoolers from low socioeconomic families in Malaysia.
METHODS: A single-blind, 2-arm cluster randomized controlled trial was conducted among 360 mother-child dyads attending government preschools in the Petaling district, who were randomly allocated into the intervention and waitlist control groups between March 2021 and December 2021. This 4-week intervention, developed using whiteboard animation videos, infographics, and a problem-solving session, was delivered via WhatsApp (WhatsApp Inc). Primary outcome was the child's screen time, whereas secondary outcomes included mother's screen time knowledge, perception about the influence of screen time on the child's well-being, self-efficacy to reduce the child's screen time and increase physical activity, mother's screen time, and presence of screen device in the child's bedroom. Validated self-administered questionnaires were administered at baseline, immediately after the intervention, and 3 months after the intervention. The intervention's effectiveness was evaluated using generalized linear mixed models.
RESULTS: A total of 352 dyads completed the study, giving an attrition rate of 2.2% (8/360). At 3 months after the intervention, the intervention group showed significantly reduced child's screen time compared with the control group (β=-202.29, 95% CI -224.48 to -180.10; P
METHODS: This study is a single blind, randomized controlled trial with two parallel arms in which participants will be allocated to VRET or IP with a ratio of 1:1. Thirty participants (18-50 years) meeting the Phobia Checklist criteria of dental phobia will undergo block randomization with allocation concealment. The primary outcome measures include participants' dental trait anxiety (Modified Dental Anxiety Scale and Dental Fear Survey) and state anxiety (Visual Analogue Scale) measured at baseline (T0), at intervention (T1), 1-week (T2), 3 months (T3) and 6 months (T4) follow-up. A behavior test will be conducted before and after the intervention. The secondary outcome measures are real-time evaluation of HR and VR (Virtual Reality) experience (presence, realism, nausea) during and following the VRET intervention respectively. The data will be analyzed using intention-to-treat and per-protocol analysis.
DISCUSSION: This study uses novel non-invasive VRET, which may provide a possible alternative treatment for dental anxiety and phobia.
TRIAL REGISTRATION NUMBER: ISRCTN25824611 , Date of registration: 26 October 2015.
OBJECTIVE: This study developed, implemented and evaluated the outcome of a chemotherapy counseling module among oncology patients by pharmacists based on their psychological effects (depression, anxiety) and selfesteem.
METHODS: A randomized, single blind, placebo controlled study was conducted among 162 patients undergoing chemotherapy in a government hospital in Malaysia.
INTERVENTION: Counseling sessions were conducted using the 'Managing Patients on Chemotherapy' module for oncology patients undergoing chemotherapy at each treatment cycle.
OUTCOME: The outcome of repetitive chemotherapy counseling using the module was determined at baseline, first follow-up, second follow-up and third follow-up.
RESULTS: The findings revealed that there was significant improvement in the intervention group as compared to the control group with large effect size on depression (p = 0.001, partial η(2) = 0.394), anxiety (p = 0.001, partial η(2) = 0.232) and self-esteem (p = 0.001, partial η(2) = 0.541).
CONCLUSION: Repetitive counseling using the 'Managing Patients on Chemotherapy' module was found to be effective in improving psychological effects and self-esteem among patients undergoing chemotherapy.
Methods: A single blind randomized controlled trial on 34 patients with COPD was conducted. The participants were divided into two groups, including honey (n = 22) and standard care (n = 12). St. George's Respiratory Questionnaire (SGRQ) was used to assess the QoL. The QoL total score was analysed using repeated measure ANOVA.
Result: There were no significant differences between the honey and standard care groups for socio-demographic and QoL variables. The within-time analysis showed statistically significant differences between baseline and post 2, 4 and 6-months in the total QoL score in the honey group. Otherwise, only marginally significant difference was detected between baseline and post 2-months in the standard care group. A comparison of total QoL score between the two groups, based on time (between and within), favoured the honey group. The honey group demonstrated a significantly lower mean total QoL score compared with the standard group at 4-months (28.89; 95% CI: 21.19, 36.59 vs 42.38; 95% CI: 31.95, 52.81) and 6 months (22.91; 95% CI: 14.94, 30.87 vs 41.95; 95% CI: 31.17, 52.73).
Conclusion: Supplementation of honey in patients with COPD results in better intermediate and long-term changes in the overall QoL.
METHODS: In this prospective, randomised, proof-of-concept study, patients with diabetes, and with peripheral neuropathy and a recent history of plantar foot ulceration were recruited from two multidisciplinary outpatient diabetic foot clinics in the UK, and were randomly assigned to either intervention or control. All patients received an insole system, which measured plantar pressure continuously during daily life. The intervention group received audiovisual alerts via a smartwatch linked to the insole system and offloading instructions when aberrant pressures were detected; the control group did not receive any alerts. The primary outcome was plantar foot ulcer occurrence within 18 months. This trial is registered with ISRCTN, ISRCTN05585501, and is closed to accrual and complete.
FINDINGS: Between March 18, 2014, and Dec 20, 2016, 90 patients were recruited and consented to the study, and 58 completed the study. At follow-up, ten ulcers from 8638 person-days were recorded in the control group and four ulcers from 11 835 person-days in the intervention group: a 71% reduction in ulcer incidence in the intervention group compared with the control group (incidence rate ratio 0·29, 95% CI, 0·09-0·93; p=0·037). The number of patients who ulcerated was similar between groups (six of 26 [control group] vs four of 32 [intervention group]; p=0·29); however, individual plantar sites ulcerated more often in the control group (ten of 416) than in the intervention group (four of 512; p=0·047). In an exploratory analysis of good compliers (n=40), ulcer incidence was reduced by 86% in the intervention group versus control group (incidence rate ratio 0·14, 95% CI 0·03-0·63; p=0·011). In the exploratory analysis, plantar callus severity (change from baseline to 6 months) was greater in re-ulcerating patients (6·5, IQR 4·0-8·3) than non-re-ulcerating patients (2·0, 0·0-4·8; p=0·040).
INTERPRETATION: To our knowledge, this study is the first to show that continuous plantar pressure monitoring and dynamic offloading guidance, provided by an innovative intelligent insole system, can lead to a reduction in diabetic foot ulcer site recurrence.
FUNDING: Diabetes UK and Orpyx Medical Technologies.
METHODS: We performed a single-blind, cross-over design study. Twenty-five healthy young men performed three exercise protocols as follows: 1) no blood flow restriction exercise (control group), 2) resistance exercise at 40% of arterial occlusion pressure (AOP) (low group), and 3) resistance exercise at 70% of AOP (high group). Blood lactate, GH, testosterone, and IGF-1 levels were measured at four time points.
RESULTS: There were no differences in the indices before exercise. The blood flow restriction exercise under different pressures had different effects on each index and there was an interactive effect. GH levels were significantly higher in the high group than in the other groups after exercise. Immediately after exercise, IGF-1 and testosterone levels were significantly higher in the high group than in the other groups. At 15 minutes after exercise, testosterone levels were significantly higher in the high group than in the other groups.
CONCLUSIONS: Low-intensity resistance exercise combined with blood flow restriction effectively increases GH, IGF-1, and testosterone levels in young men. Increasing the cuff pressure results in greater levels of hormone secretion.
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