The Effect of Yoga Self-Practice on Sleep Disturbance

NCT ID: NCT04719039

Last Updated: 2021-01-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-28
• Study Completion Date: 2021-05-31

Brief Summary

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.

Detailed Description

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.

Conditions

Yoga

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Yoga Group

Restorative Yoga intervention

Group Type: EXPERIMENTAL

Restorative Yoga Internvention

Intervention Type: BEHAVIORAL

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.

Waitlist Control Group

Participants in the waitlist control group will receive the intervention after the immediate post-treatment assessment

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Restorative Yoga Internvention

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. Hong Kong residents aged 18-59 years;

2. Cantonese language fluency;

3. A global Insomnia Severity Index (ISI) score of 10 or higher;

4. No yoga experience within the 6 months before the study; and

5. A willingness to provide informed consent and comply with the trial protocol.

Exclusion Criteria

Participants were excluded if they

1. are pregnant;

2. are having unsafe conditions and are not recommended for restorative yoga by physicians;

3. have major psychiatric, medical or neurocognitive disorders that make participation infeasible or interfere with the adherence to the yoga practice;

4. have insomnia due to specific medical conditions, side effects of medication intake or other sleep disorders; and

5. are shift workers.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 59 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Chinese University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

Fiona YY Ho

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

The Chinese University of Hong Kong

Shatin, , Hong Kong

Countries

Hong Kong

Central Contacts

Tina Chan

Role: CONTACT

1009613291@link.cuhk.edu.hk

+852 3943 6575

Other Identifiers

PSY014

Identifier Type: -

Identifier Source: org_study_id