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 report 12-month post-treatment data from a single-blind, active-controlled trial (October 2017-August 2019) where 327 Myanmar refugees in Malaysia were assigned to either six sessions of IAT (n = 164) or cognitive behavioral treatment (CBT) (n = 163). Primary outcomes were posttraumatic stress disorder (PTSD), depression, anxiety, and persistent complex bereavement disorder (PCBD) symptom scores at treatment end and 12-month post-treatment. Secondary outcome was functional impairment.
RESULTS: 282 (86.2%) participants were retained at 12-month follow-up. For both groups, large treatment effects for common mental disorders (CMD) symptoms were maintained at 12-month post-treatment compared to baseline (d = 0.75-1.13). Although participants in IAT had greater symptom reductions and larger effect sizes than CBT participants for all CMDs at treatment end, there were no significant differences between treatment arms at 12-month post-treatment for PTSD [mean difference: -0.9, 95% CI (-2.5 to 0.6), p = 0.25], depression [mean difference: 0.1, 95% CI (-0.6 to 0.7), p = 0.89), anxiety [mean difference: -0.4, 95% CI (-1.4 to 0.6), p = 0.46], and PCBD [mean difference: -0.6, 95% CI (-3.1 to 1.9), p = 0.65]. CBT participants showed greater improvement in functioning than IAT participants at 12-month post-treatment [mean difference: -2.5, 95% CI (-4.7 to -0.3], p = 0.03]. No adverse effects were recorded for either therapy.
CONCLUSIONS: Both IAT and CBT showed sustained treatment gains for CMD symptoms amongst refugees over the 12-month period.
MATERIALS AND METHODS: A randomised control study with a two-group, single-blind design and baseline evaluation was selected. Social media sites were used to advertise for participants, who were then admitted after meeting the requirements. Participants who met the eligibility requirements were randomly split into two groups. Each group received a total of three sessions of online therapy (MT or CT), once every two weeks, as well as one phone call per week as reinforcement. At the beginning and end of the intervention, participants completed questionnaires (1st week and 5th week). Generalized Estimating Equation (GEE) statistical analysis was used to analyse all the variables.
RESULTS: The MT group experienced a statistically significant decrease in cigarette consumption (β: -3.50, 95% Wald CI: - 4.62, -2.39) compared to the CT group over time. Furthermore, the MT group demonstrated significant improvements in their scores for the AAQ-2, anxiety, stress, depression and mindfulness compared to the CT group.
CONCLUSION: Online MT is more successful at assisting smokers in lowering their daily cigarette intake and supporting their mental health during the smoking cessation process. Further longitudinal comparisons of the effectiveness of online MT should be undertaken using online platforms in future studies.
MATERIALS AND METHODS–STUDY PROTOCOL: A total of 60 pairs of persons with PD of stage II and III, and their primary family caregiver will be recruited and allocated into either an experimental or a control group for 12 weeks of intervention. The experimental group will undergo initial training from multi-disciplinary healthcare providers and will be given a physical module containing weekly tasks that must be practised at home. While the control group will receive a usual care. Both groups will be assessed in terms of physical functions, functional mobility, quality of life (QoL), caregiver burden and knowledge using standardised assessment tools namely Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS), Timed Up and Go (TUG) test, Parkinson's Disease Questionnaire (PDQ-39), European Quality of Life five-dimensions (EQ-5D), Malay version of Zarit Burden Interview (MZBI) and Knowledge of Parkinson Disease Questionnaire (KPDQ). In addition, the feasibility and sustainability of the interventions will be evaluated, alongside its cost-effectiveness based on the average and incremental cost effectiveness ratio. All data will be analysed using descriptive and inferential statistics, particularly mixed model ANOVA.
DISCUSSION: There is a significant gap in the literature pertaining family caregiver training programs for people with PD. Documented programs are lacking in term of comprehensiveness of content, application approach and the measurement of training outcomes including the program cost-effectiveness. The feasibility and effectiveness of such training program in a Malaysian setting also requires investigation due to differences in living environment, support system and population's perception. This study will assist to fulfil the existing literature gap and demonstrate the potential benefit of caregiver involvement in mediating the care and therapy for PD in the home setting. Optimum knowledge and skills gained through the training are expected to enhance the confidence and ability of the family caregivers and may possibly reduce their perceived caregiving burden.
PROTOCOL REGISTRATION: The protocol of this study is registered in the Australian-New Zealand Clinical Trial Registry (ANZCTR) with a registration number ACTRN12623000336684.
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
BACKGROUND: An overwhelming number of studies in the West have been conducted on the use of background music in reducing patients' anxiety and their perception of hospitals. Despite the optimism for Western classical music in such settings, evidence documenting the successful use of this genre of music in waiting rooms across other people groups has, thus far, been inconclusive.
METHOD: A single-blind randomized study in which a total of 303 participants were recruited from both surgery and radiology clinics using a between-groups experimental design. Patients were seated in the waiting room for at least 20 min while music (Western classical, lo-fi) or no music was playing in the background. Participants were then required to complete a questionnaire that consisted of a shortened 6-item State Trait Anxiety Inventory (STAI-6), and eight questions relating to overall perceptions of the hospital.
RESULTS: The results from both clinics revealed that patients in the no music condition rated themselves as feeling significantly less anxious than those in either of the two music conditions. Patients' perceptions of the hospital's overall service and expectations were higher in the no music condition.
CONCLUSIONS: Firstly, the choice of background music should match the differing pace of the day; for example, a more upbeat song would better fit the mood of a busy clinic, leading to a more "congruent" atmosphere. Secondly, playing background music in a "task-oriented" and highly charged/anxious environment may increase arousal levels, which in turn could result in negative perceptions of the hospital and an increase in anxiety among patients. Finally, music is a cultural product and music that primes certain beliefs in one culture may not have similar effects among other people groups. Hence, specific curated playlists are necessary to convey "intentions" to different people groups.
METHODS: A single-masked randomized trial was conducted in a single tertiary care center from July 2021 to January 2022. Two hundred fourteen participants aged 18 years or older who were scheduled for outpatient Pipelle endometrial sampling were randomized: 107 each to having a full bladder (by oral water intake) or standard process (without delayed sampling and bladder status not taken into account). Women with known cervical stenosis, gynecologic malignancy, uterine anomalies, leiomyoma distorting the uterine cavity, acute cervicitis, urge bladder dysfunction, intense anxiety, need for anesthesia or analgesic before the procedure, positive pregnancy test, or previous failed office endometrial sampling were excluded. The primary outcome was the insertion failure rate of endometrial sampling at first attempt. Secondary outcomes were pain during procedure, satisfaction score, analgesia use, procedure duration, and need for cervical manipulation. Factoring in a baseline insertion failure rate of 30.0%, relative risk of 0.45, α of 0.05, 80.0% power, and a dropout rate of 10.0%, we needed 107 participants in each arm.
RESULTS: The insertion failure rate was significantly lower in the full bladder group compared with standard process: 25 of 107 (23.4%) compared with 45 of 107 (42.1%) (relative risk 0.56, 95% CI, 0.37-0.84; number needed to treat to benefit 6.0, 95% CI, 3.20-15.70). Pain score (median) during the procedure (interquartile range) was 4 (3-6) compared with 5 (3-8) ( P =.004); patient satisfaction score was 8 (7-9) compared with 7 (4-8) ( P
METHODS: A total of 29 patients aged 10 to 18 received a daily oral dose of 50 mg TRF for six months (January 2020 to February 2022), and all had fatty liver disease were detected by ultrasonography and abnormally high alanine transaminase levels (at least two-fold higher than the upper limits for their respective genders). Various parameters, including biochemical markers, FibroScan, LiverFASt, DNA damage, and cytokine expression, were monitored.
RESULTS: APO-A1 and AST levels decreased significantly from 1.39 ± 0.3 to 1.22 ± 0.2 g/L (P = 0.002) and from 30 ± 12 to 22 ± 10 g/L (P = 0.038), respectively, in the TRF group post-intervention. Hepatic steatosis was significantly reduced in the placebo group from 309.38 ± 53.60 db/m to 277.62 ± 39.55 db/m (p = 0.048), but not in the TRF group. Comet assay analysis showed a significant reduction in the DNA damage parameters in the TRF group in the post-intervention period compared to the baseline, with tail length decreasing from 28.34 ± 10.9 to 21.69 ± 9.84; (p = 0.049) and with tail DNA (%) decreasing from 54.13 ± 22.1to 46.23 ± 17.9; (p = 0.043). Pro-inflammatory cytokine expression levels were significantly lower in the TRF group compared to baseline levels for IL-6 (2.10 6.3 to 0.7 1.0 pg/mL; p = 0.047 pg/mL) and TNF-1 (1.73 5.5 pg/mL to 0.7 0.5 pg/mL; p = 0.045).
CONCLUSION: The study provides evidence that TRF supplementation may offer a risk-free treatment option for children with obesity and NAFLD. The antioxidant and anti-inflammatory properties of TRF offer a promising adjuvant therapy for NAFLD treatment. In combination with lifestyle modifications such as exercise and calorie restriction, TRF could play an essential role in the prevention of NAFLD in the future. However, further studies are needed to explore the long-term effects of TRF supplementation on NAFLD in children.
TRIAL REGISTRATION: The study has been registered with the International Clinical Trial Registry under reference number (NCT05905185) retrospective registration on (15/06/2023).
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.