- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05948280
Virtual Reality (VR) Based Mindfulness Practice in Relieving Stress in Postgraduate Students
Virtual Reality-supported Mindfulness Practice in Relieving Stress in Postgraduate Students: a Pilot Randomised Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
A three-arm, assessor-blinded pilot randomised controlled trial (RCT) will be implemented. Participants will be randomly assigned to either mindfulness group, VR mindfulness group and control group. Participants will be randomised at a 1:1:1 ratio to the intervention groups or control group. Block randomization will be conducted by an independent research assistant using randomly varying block sizes of 4 and 6 to avoid selection bias. This study aims to test the feasibility, acceptability, and preliminary effects of the VR-based mindfulness practice in improving stress for graduate students.
Specific objectives are as follows:
- To investigate the feasibility and acceptability of the VR-based mindfulness practice in improving stress for graduate students
- To investigate the preliminary effects of VR-based mindfulness practice in improving stress for graduate students
- To understand the user experience of mindfulness practice in VR
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Huiyuan LI, PhD
- Phone Number: 52665977
- Email: huiyuanli@cuhk.edu.hk
Study Locations
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Hong Kong
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Hong Kong, Hong Kong, China, 999077
- The Chinese University of Hong Kong
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Contact:
- Huiyuan LI, PhD
- Phone Number: 52665977
- Email: huiyuanli@cuhk.edu.hk
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- aged 18 or over;
- enrolled in graduate programme at the Chinese University of Hong Kong;
- experienced stress: the score of perceived stress scale more than 13;
- able to speak and write in English
Exclusion Criteria:
- diagnosed with psychiatric disorders;
- currently taking psychotropic medication;
- have history of photosensitive epilepsy or previous experience of severe simulator sickness;
- receiving or have just completed other psychological interventions (e.g. stress management, mental health support, peer support, etc) within the last six months will be excluded; or
- history of seizures and motion sickness.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: VR-supported mindfulness group
Participants in the intervention group will receive VR mindfulness intervention, consisting of four face-to-face sessions (twice a week for two weeks).
During the first week, the interventionist will teach and guide the participant face-to-face.
During the second week, participants will be required to practice VR on their own for self-help.
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A single mindful stretching exercise provides a conscious stretch of VR scenario.
The implementation of VR exercises will be performed by the interventionist who have received training in the application of VR scenarios and have extensive experience in VR research.
|
|
Active Comparator: Mindfulness group
Participants in this group will receive a mindfulness exercise guided by the interventionist twice a week for two weeks.
|
The interventionist will guide the participant to do a mindful stretching exercise in the first week.
During the second week, the interventionist will send participants an audio recording on how to do mindful stretching exercise via WeChat/WhatsApp.
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No Intervention: Control group
Participants in the control group will not receive mindfulness or mindfulness plus VR.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Eligibility rate
Time Frame: Baseline
|
The eligibility rate is defined as the percentage of participants fulfilling the inclusion criteria amongst the participants screened for the eligibility
|
Baseline
|
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Recruitment rate
Time Frame: Baseline
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The recruitment rate is defined as the percentage of participants who consented to participate in the study amongst the participants eligible for the study
|
Baseline
|
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Attrition rate
Time Frame: Week 2
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The attrition rate is defined as the percentage of participants who withdrew from the study before completion
|
Week 2
|
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Adherence rate
Time Frame: Week 2
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The adherence rate is defined as the frequency of the practice of mindfulness and session attendance
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Week 2
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Change from baseline in the score of perceived stress assessed by The Perceived Stress Scale to immediately after the intervention
Time Frame: Baseline and Week 2 (post-intervention)
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A 10-item self-report instrument that measures the degree to which events are appraised as stressful and the frequency of perceived stressful situations.
Students will be instructed to report the frequency of perceived stress over the past month from 0 (Never) to 4 (Very Often).
Total scores on the PSS can range from 0 to 40.
Higher total scores indicate higher levels of perceived stress.
|
Baseline and Week 2 (post-intervention)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from baseline in the score of mindfulness assessed by The Five Facet Mindfulness Questionnaire to immediately after the intervention
Time Frame: Baseline and Week 2 (post-intervention)
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A 39-item self-report instrument that measures levels of mindfulness, including five facets: observing, describing, acting with awareness, non-judging of inner experience and non-reactivity to inner experience.
Students will be invited to indicate on a 5-point Likert scale the degree to which each item is generally true for them, ranging from 1 to 5. Higher scores indicate higher levels of mindfulness.
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Baseline and Week 2 (post-intervention)
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Change from baseline in the level of mood states by The abbreviated Profile of Mood States to immediately after the intervention
Time Frame: Baseline and Week 2 (post-intervention)
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A 40-item self-report instrument that measures seven different subscales of transient mood states.
Each question is score from 0 to 4. High scores indicate great mood disturbance.
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Baseline and Week 2 (post-intervention)
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Acceptability of the intervention
Time Frame: Week 2
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Participants in the VR mindfulness group will be asked to provide qualitative feedback via a semi-structured interview.
The interview questions focused on eliciting the participants' view about the VR experience, facilitators and barriers for VR-based mindfulness practice, and the positive and negative features of VR, which may help or hinder the mindfulness practice.
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Week 2
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Cho Lee WONG, PhD, The Nethersole School of Nursing, Chinese University of Hong Kong
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- CREC Ref. No. 2023.216
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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