The Effect of Restorative Yoga Self-Practice on Sleep Disturbance: A Pilot Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Sleep Diary - Change in total sleep time (TST)
研究概览
简要总结
The study will examine the effect of Restorative Yoga self-practice on sleep disturbance in the Chinese adult population. Restorative Yoga is a relaxation-focused yoga style which includes a series of static stretching poses and mindful breathing. Existing literature has demonstrated that face-to-face yoga sessions of different types are effective in improving sleep disturbance and reducing the severity of insomnia. There were pilot studies conducted on the effect of yoga on cancer patients' sleep quality, but research that focuses on insomnia population is rare (Wang et al., 2020). In addition, there is very limited research on the effectiveness of self-practice without the presence of a yoga instructor. Given the social distancing policy under COVID-19 and the need to stay home, this study can shed light on whether self-practice at home can be an effective alternative to face-to-face yoga sessions.
详细描述
This study will be a pilot randomized controlled trial on the effectiveness of restorative yoga self-practice for sleep disturbance. Prior to all study procedures, online informed consent (with phone support) will be obtained from potential participants. Around 30 eligible participants will be randomly assigned to either the yoga group (intervention group) or the waitlist control group in a ratio of 1:1. The randomization will be performed by an independent assessor using a computer-generated list of numbers. No deception is necessary.
Participants in the intervention group will receive links to two 60-min videos per week for 8 consecutive weeks. Each video will include a yoga practice guided by a certified yoga instructor. The intervention group is required to perform the yoga practice at least two times per week. If preferred, they can do additional sessions with the videos and record their total hours of self-practice. The waitlist control group will receive the video links subsequent to the 8-week study. The intervention group will complete a set of online questionnaires before the intervention commences, weekly during the intervention period, immediately after the intervention, and 4 weeks after the intervention. The waitlist control group will complete the same set of online questionnaires before the intervention commences and immediately after 8-week intervention period has ended.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Hong Kong residents aged 18-59 years;
- •Cantonese language fluency;
- •A global Insomnia Severity Index (ISI) score of 10 or higher;
- •No yoga experience within the 6 months before the study; and
- •A willingness to provide informed consent and comply with the trial protocol.
排除标准
- •Participants were excluded if they
- •are pregnant;
- •are having unsafe conditions and are not recommended for restorative yoga by physicians;
- •have major psychiatric, medical or neurocognitive disorders that make participation infeasible or interfere with the adherence to the yoga practice;
- •have insomnia due to specific medical conditions, side effects of medication intake or other sleep disorders; and
- •are shift workers.
结局指标
主要结局
Sleep Diary - Change in total sleep time (TST)
时间窗: Baseline, intervention period (8 weeks), immediately and 4-week post-intervention
The standardized sleep diary records wake time to measure sleep disturbance.
Change in Pittsburgh Sleep Quality Index (PSQI)
时间窗: Baseline, intervention period (8 weeks), immediate and 4-week post-intervention
The PSQI-19 is a 19-item questionnaire used for measuring and identifying quality of sleep. It provides a measure of global sleep quality, including sleep latency, sleep duration, habitual sleep efficiency and sleep disturbances.
Sleep Diary - Change in sleep-Onset latency (SOL)
时间窗: Baseline, intervention period (8 weeks), immediately and 4-week post-intervention
The standardized sleep diary records the length of time that it takes to accomplish the transition from full wakefulness to sleep on a daily basis.
Sleep Diary - Change in wake after sleep onset (WASO)
时间窗: Baseline, intervention period (8 weeks), immediately and 4-week post-intervention
The standardized sleep diary records the periods of wakefulness occurring after defined sleep onset on a daily basis, reflecting sleep fragmentation.
Sleep Diary - Change in sleep efficiency (SE)
时间窗: Baseline, intervention period (8 weeks), immediately and 4-week post-intervention
The Sleep efficiency is measured in percentage by dividing TST by total time in bed.
Change in Insomnia Severity Index (ISI)
时间窗: Baseline, intervention period (8 weeks), immediately and 4-week post-intervention
ISI is a 7-item scale designed to evaluate perceived insomnia severity. Ratings on the 5-point Likert scale are obtained on the perceived severity of sleep-onset, sleep-maintenance, early morning awakening problems, satisfaction with current sleep pattern, interference with daily functioning, noticeably of impairment attributed to the sleep problem, and level of distress caused by the sleep problem.
Sleep Diary - Change in total wake time (TWT)
时间窗: Baseline, intervention period (8 weeks), immediately and 4-week post-intervention
The standardized sleep diary records wake time to measure sleep disturbance.
次要结局
- Change in Hospital Anxiety and Depression Scale (HADS-14)(Baseline, immediately after the 8-week intervention, and 4-week post-intervention)
- Change in Multidimensional Fatigue Inventory (MFI-20)(Baseline, immediately after the 8-week intervention, and 4-week post-intervention)
- Change in Short Form (Six-Dimension) Health Survey (SF-6D)(Baseline, immediately after the 8-week intervention, and 4-week post-intervention)
- Change in Credibility-Expectancy Questionnaire (CEQ)(Baseline, immediately after the 8-week intervention, and 4-week post-intervention)
研究者
Fiona YY Ho
Assistant Professor
Chinese University of Hong Kong