Displaying publications 1 - 20 of 132 in total

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  1. Tang MY, Tang IP, Wang CY
    Med J Malaysia, 2014 Aug;69(4):151-5.
    PMID: 25500841 MyJurnal
    AIM: This was a randomized single blinded study to determine optimal size for Ambu®LMA (ALMA) among Malaysian adult population.

    METHODS: One hundred and twenty six non-paralyzed anaesthetized adult patients were block randomized into size 3, 4 and 5 Ambu®LMA. Optimal size is defined primarily by oropharyngeal pressure (OLP). Pharyngeal injury and ease of insertion are also taken into consideration.

    RESULTS: Mean OLP was significantly higher for Size 4 and 5 compared to size 3 (p<0.001) but similar between size 4 and 5. Number of insertion attempts and insertion time were similar between sizes. Size 5 required more manipulations during insertion (p<0.005) and had higher pharyngeal injury (p=0.001) compared to size 3 and 4.

    DISCUSSION: We recommend size 4 ALMA as the optimal size for Malaysian adults in view of the higher OLP compared to size 3, yet less pharyngeal injury than size 5 in spontaneously breathing patients.
    Matched MeSH terms: Single-Blind Method
  2. Deylami N, Hassan SA, Alareqe NA, Zainudin ZN
    PMID: 34501535 DOI: 10.3390/ijerph18178945
    Amounting evidence indicates that insufficient knowledge of marital communication skills leads to destructive interactions and poor marital adjustments in couples, especially during stressful situations. Despite the high effectiveness of Gottman's psychoeducational intervention, there is a lack of study on the online Gottman's psychoeducation intervention (O-GPI) to improve marital communication and dyadic adjustments. The aim of this study was to evaluate the effectiveness of O-GPI on the improvement of marital communication patterns among Iranian couples.

    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.

    Matched MeSH terms: Single-Blind Method
  3. Tay AK, Mohsin M, Foo CYS, Rees S, Silove D
    Psychol Med, 2023 Oct;53(13):6055-6067.
    PMID: 36330832 DOI: 10.1017/S0033291722003245
    BACKGROUND: Long-term efficacy of brief psychotherapies for refugees in low-resource settings is insufficiently understood. Integrative adapt therapy (IAT) is a scalable treatment addressing refugee-specific psychosocial challenges.

    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.

    Matched MeSH terms: Single-Blind Method
  4. Hemanath S, Robinson F, Pang NTP, Lim EK, Ong SJ, Alyssa S, et al.
    Med J Malaysia, 2023 May;78(3):336-343.
    PMID: 37271843
    INTRODUCTION: Effective smoking cessation programmes are essential for assisting smokers in quitting, indirectly lowering mortality and morbidity associated with smoking. Numerous studies have indicated positive outcomes when using mindfulness treatment (MT) to treat psychological or behavioural health issues. Although to date, no study has looked at the effectiveness of online MT for quitting smoking while addressing mental health, particularly among the Asian population. Therefore, this study compares the efficiency of online MT to traditional counselling therapy (CT) in aiding smoking cessation programmes while also addressing mental health.

    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.

    Matched MeSH terms: Single-Blind Method
  5. Weerkamp-Bartholomeus P, Marazziti D, Chan E, Srivastava A, van Amelsvoort T
    Heliyon, 2020 Aug;6(8):e04660.
    PMID: 32802985 DOI: 10.1016/j.heliyon.2020.e04660
    Background: Generally, neuropsychiatric patients share different symptoms across nosological categories, such as, amongst other, psychological distress, mood alterations, anxiety, and self-regulation disturbances.ReAttach is a novel psychological intervention with its key elements being external affect and arousal regulation, stimulation of multiple sensory processing, conceptualization, affective mentalization, and associative memory processing. ReAttach has been hypothesized to be effective in reducing symptom severity in different psychiatric conditions. Given the limited information currently available, the present study aimed to investigate the effect of main ReAttach elements called "Wiring Affect with ReAttach" (W.A.R.A.) on negative affect (N.A.), and to compare it with "Distraction," another well-established affect-regulating strategy.

    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.

    Matched MeSH terms: Single-Blind Method
  6. Aribi Al-Zoobaee FW, Yee Shen L, Veettil SK, Gopinath D, Maharajan MK, Menon RK
    PMID: 33265920 DOI: 10.3390/ijerph17238891
    Cancer therapy may be complicated and compromised by viral infections, including oral herpes simplex virus (HSV) infection. This network meta-analysis aimed to identify the best antiviral agent to prevent or treat oral HSV infection in patients being treated for cancer. A search was conducted for trials published since inception until the 10th of May 2020 in MEDLINE, EMBASE and the Cochrane Central Register of Controlled Trials. A network meta-analysis was performed on the data from randomized controlled trials that assessed antiviral agents for preventive or therapeutic activity vs. placebo, no treatment or any other active intervention in patients being treated for cancer. The agents were ranked according to their effectiveness in the prevention of oral HSV using surface under the cumulative ranking (SUCRA). Grading of Recommendations, Assessment, Development and Evaluations (GRADE) was used to assess the certainty of the evidence. In total, 16 articles were included. The pooled relative risk (RR) to develop oral HSV infection in the acyclovir group was 0.17 (95% CI: 0.10, 0.30), compared to 0.22 (95% CI: 0.06, 0.77) in the valacyclovir group. Acyclovir ranked highest for the prevention of oral HSV followed by valacyclovir. Subgroup analysis with different acyclovir regimens revealed that the best regimens in terms of HSV-1 prevention were 750 mg/m2 acyclovir administered intravenously followed by 1600 mg per day orally. Acyclovir (250 mg/m2 per day) administered intravenously was the least effective against the prevention of oral HSV.
    Matched MeSH terms: Single-Blind Method
  7. Farzin A, Ibrahim R, Madon Z, Basri H, Farzin S, Motalebizadeh A
    Front Public Health, 2021;9:594953.
    PMID: 33968872 DOI: 10.3389/fpubh.2021.594953
    Prospective Memory (PM) is a cognitive function affected by aging. PM is the memory of future intentions and is significantly involved in everyday life, especially among older adults. Nevertheless, there are a few studies focused on PM training among healthy older adults and these studies did not report the optimal duration of training regarding improving PM performance among older adults. The present study aimed to determine the effective duration for training PM performance among healthy older adults. The current study was a randomized, controlled, single-blind, within-participants crossover trial including a training program with a duration of 12 h. The sample of 25 older adults aged 55 to 74 years recruited from the active members of the University of the Third Age (U3A), Kuala Lumpur/Selangor, their family members, and friends. The study design ensured some participants would receive the training after baseline while others would wait for 6 weeks after the baseline before receiving the training. All participants were evaluated five times: at baseline, 6, 12, 16, and at 24 weeks post-baseline. Moreover, the training program ensured all participants were assessed after each training session. The minimum number of hours to achieve training effects for this multi-component training program was eight. Results supported the efficacy of the training program in improving PM performance among healthy older adults. Also, the optimal duration for the multicomponent training program on PM performance among healthy older adults was obtained. This trial is registered at isrctn.com (#ISRCTN57600070).
    Matched MeSH terms: Single-Blind Method
  8. Siner A, Sevanesan MS, Ambomai T, Abd Wahab Z, Lasem L
    BMC Res Notes, 2020 Aug 28;13(1):404.
    PMID: 32859257 DOI: 10.1186/s13104-020-05250-8
    OBJECTIVE: Glycaemic Index (GI) ranks the body's response to carbohydrate content in food such that high GI food increases postprandial blood glucose levels. One of the popular drinks at food and beverage outlets is a drink made from calamansi, a citrus that is believed not to induce an increase in blood glucose levels. In this non-randomised single-blind (participants) study, capillary blood from 10 healthy males were sampled following consumption of either glucose or the calamansi drink. The blood glucose measurements were then used to calculate the GI for the drink.

    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.

    Matched MeSH terms: Single-Blind Method
  9. Mohd Tariq MN, Shahar HK, Baharudin MR, Ismail SNS, Manaf RA, Salmiah MS, et al.
    BMC Public Health, 2021 09 24;21(1):1735.
    PMID: 34560858 DOI: 10.1186/s12889-021-11719-3
    BACKGROUND: Flood disaster preparedness among the community seldom received attention. Necessary intervention must be taken to prevent the problem. Health Education Based Intervention (HEBI) was developed following the Health Belief Model, particularly in improving flood disaster preparedness among the community. The main objective of this study is to assess the effect of HEBI on improving flood disaster preparedness among the community in Selangor. This study aims to develop, implement, and evaluate the impact of health education-based intervention (HEBI) based on knowledge, skills, and preparedness to improve flood disaster preparedness among the community in Selangor.

    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 .

    Matched MeSH terms: Single-Blind Method
  10. Raj D, Ahmad N, Mohd Zulkefli NA, Lim PY
    J Med Internet Res, 2023 May 04;25:e40955.
    PMID: 37140970 DOI: 10.2196/40955
    BACKGROUND: High prevalence of excessive screen time among preschool children is attributable to certain parental factors such as lack of knowledge, false perception about screen time, and inadequate skills. Lack of strategies to implement screen time guidelines, in addition to multiple commitments that may hinder parents from face-to-face interventions, demands the need to develop a technology-based parent-friendly screen time reduction intervention.

    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

    Matched MeSH terms: Single-Blind Method
  11. Yeoh JPS, Spence C
    HERD, 2023 Jul;16(3):278-290.
    PMID: 37016842 DOI: 10.1177/19375867231161094
    OBJECTIVES: To assess the impact of different types of background music on patients' anxiety and perceptions in a healthcare setting.

    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.

    Matched MeSH terms: Single-Blind Method
  12. Izny Hafiz Z, Rosdan S, Mohd Khairi MD
    Med J Malaysia, 2014 Apr;69(2):74-8.
    PMID: 25241816 MyJurnal
    The objective of this study was to compare the intraoperative time, intraoperative blood loss and post operative pain between coblation tonsillectomy and cold tonsillectomy in the same patient. A prospective single blind control trial was carried out on 34 patients whom underwent tonsillectomy. The patients with known bleeding disorder, history of unilateral peritonsillar abscess and unilateral tonsillar hypertrophy were excluded. Operations were done by a single surgeon using cold dissection tonsillectomy in one side while coblation tonsillectomy in the other. Intraoperative time, intraoperative blood loss and post operative pain during the first 3 days were compared between the two methods. Results showed that the intraoperative time was significantly shorter (p<0.001) and intraoperative blood loss was significantly lesser (p<0.001) in coblation tonsillectomy as compared to cold tonsillectomy. Post operative pain score was significantly less at 6 hours post operation (p<0.001) in coblation tonsillectomy as compared to cold tonsillectomy. However, there were no differences in the post operative pain scores on day 1, 2 and 3. In conclusion, coblation tonsillectomy does have superiority in improving intraoperative efficiency in term of intraoperative time and bleeding compared to cold dissection tonsillectomy. The patient will benefit with minimal post operative pain in the immediate post surgery duration.
    Matched MeSH terms: Single-Blind Method
  13. Leong WS, Liong ML, Liong YV, Wu DB, Lee SW
    Urology, 2014 Jan;83(1):40-4.
    PMID: 24044912 DOI: 10.1016/j.urology.2013.08.004
    To determine the efficacy of a combination of simultaneous shock wave lithotripsy (SWL), hydration with controlled inversion therapy compared with SWL with hydration alone in patients with lower pole calyx stones.
    Matched MeSH terms: Single-Blind Method
  14. Raghav K, Van Wijk AJ, Abdullah F, Islam MN, Bernatchez M, De Jongh A
    BMC Oral Health, 2016 Feb 27;16:25.
    PMID: 26920573 DOI: 10.1186/s12903-016-0186-z
    BACKGROUND: Virtual Reality Exposure Therapy (VRET) is found to be a promising and a viable alternative for in vivo exposure in the treatment of specific phobias. However, its usefulness for treating dental phobia is unexplored. The aims of the present study are to determine: (a) the efficacy of VRET versus informational pamphlet (IP) control group in terms of dental trait and state anxiety reductions at 1 week, 3 months and 6 months follow-up (b) the real-time physiological arousal [heart rate (HR)] of VRET group participants during and following therapy (c) the relation between subjective (presence) and objective (HR) measures during VRET.

    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.

    Matched MeSH terms: Single-Blind Method
  15. Malek F, Rani KA, Rahim HA, Omar MH
    Sci Rep, 2015;5:13206.
    PMID: 26286015 DOI: 10.1038/srep13206
    Individuals who report their sensitivity to electromagnetic fields often undergo cognitive impairments that they believe are due to the exposure of mobile phone technology. The aim of this study is to clarify whether short-term exposure at 1 V/m to the typical Global System for Mobile Communication and Universal Mobile Telecommunications System (UMTS) affects cognitive performance and physiological parameters (body temperature, blood pressure and heart rate). This study applies counterbalanced randomizing single blind tests to determine if sensitive individuals experience more negative health effects when they are exposed to base station signals compared with sham (control) individuals. The sample size is 200 subjects with 50.0% Idiopathic Environmental Intolerance attributed to electromagnetic fields (IEI-EMF) also known as sensitive and 50.0% (non-IEI-EMF). The computer-administered Cambridge Neuropsychological Test Automated Battery (CANTAB eclipse(TM)) is used to examine cognitive performance. Four tests are chosen to evaluate Cognitive performance in CANTAB: Reaction Time (RTI), Rapid Visual Processing (RVP), Paired Associates Learning (PAL) and Spatial Span (SSP). Paired sample t-test on the other hand, is used to examine the physiological parameters. Generally, in both groups, there is no statistical significant difference between the exposure and sham exposure towards cognitive performance and physiological effects (P's > 0.05).
    Matched MeSH terms: Single-Blind Method
  16. Ummavathy P, Sherina MS, Rampal L, Siti Irma Fadhilah I
    Med J Malaysia, 2015 Jun;70(3):131-41.
    PMID: 26248774 MyJurnal
    INTRODUCTION: Chemotherapy is the most common form of treatment among cancer patients. It is also known to cause many physical and psychological side-effects.

    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.

    Matched MeSH terms: Single-Blind Method
  17. Amir Faisal Mohd. Khairi, Hejar Abdul Rahman, Norsiah Ali
    MyJurnal
    Introduction: Methadone Maintenance Treatment (MMT) is the commonly used intervention for opioid dependents among Malays in FELDA settlements. However, relapse is common. Since majority of Malays are Muslims, Islamic Rehabilitation Intervention Module (ISRIM) using Health Belief Model (HBM) can be implemented as an intervention for reduction of relapse among opioid dependents in FELDA community. The objective of this study were to develop, implement and evaluate the effectiveness of ISRIM in the reduction of relapse among opioids dependent Malay males in FELDA communities in Jengka, Pahang. Methods: A single blind, cluster randomized controlled trial utilizing simple randomization was conducted, involving 10 MMT clinics. Intervention group received ISRIM for one session per week for four consecutive weeks, while control group were put on wait-list. Outcome was relapse, measured monthly for 6 months follow-up by the positive urine for drugs rapid test. Generalized Estimating Equations (GEE) was used as the main effectiveness analysis. Intention-to-treat (ITT), per protocol (PP) analysis, interaction terms, construct terms and key assumption terms were utilized. Results: Individual participation rate was 88.3%. All group comparisons at baseline were not significant (p>0.05). Cumulative relapse after 6-months follow-up for intervention and control group was 13.8% and 31.2%. There was significant difference in relapse between baseline, post-inter-vention and 6-months follow-up within intervention and control group (Q=29.06 vs 61.39,p
    Matched MeSH terms: Single-Blind Method
  18. Muhamad R, Draman N, Aziz AA, Abdullah S, Jaeb MZM
    J Taibah Univ Med Sci, 2018 Feb;13(1):42-50.
    PMID: 31435301 DOI: 10.1016/j.jtumed.2017.05.014
    Objectives: This study aimed to assess the efficacy of a 6-months regime of honey supplementation in improving the quality of life (QoL) of patients with chronic obstructive pulmonary disease (COPD).

    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.

    Matched MeSH terms: Single-Blind Method
  19. Abbott CA, Chatwin KE, Foden P, Hasan AN, Sange C, Rajbhandari SM, et al.
    Lancet Digit Health, 2019 10;1(6):e308-e318.
    PMID: 33323253 DOI: 10.1016/S2589-7500(19)30128-1
    BACKGROUND: Prevention of diabetic foot ulcer recurrence in high risk patients, using current standard of care methods, remains a challenge. We hypothesised that an innovative intelligent insole system would be effective in reducing diabetic foot ulcer recurrence in such patients.

    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.

    Matched MeSH terms: Single-Blind Method
  20. Yinghao L, Jing Y, Yongqi W, Jianming Z, Zeng G, Yiting T, et al.
    J Int Med Res, 2021 Sep;49(9):3000605211039564.
    PMID: 34486432 DOI: 10.1177/03000605211039564
    OBJECTIVE: To investigate the changes in serum growth hormone (GH), testosterone, and insulin-like growth factor 1 (IGF-1) during low-intensity resistance exercise under different cuff pressures.

    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.

    Matched MeSH terms: Single-Blind Method
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