Virtual Reality (VR) Based Mindfulness Practice in Relieving Stress in Postgraduate Students

Stress Clinical Trial

Official title:

Virtual Reality-supported Mindfulness Practice in Relieving Stress in Postgraduate Students: a Pilot Randomised Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05948280
• Other study ID #: CREC Ref. No. 2023.216
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 2023
• Est. completion date: January 2024

Study information

• Verified date: July 2023
• Source: Chinese University of Hong Kong
• Contact: Huiyuan LI, PhD
• Phone: 52665977
• Email: huiyuanli[@]cuhk.edu.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

University students, especially graduate students, are constantly striving to achieve their goals, and their performance is constantly being evaluated, which creates a plethora of stressors, such as tests, a large amount of content to be learnt, lack of time, getting poor marks, and living up to their expectations. Mindfulness has been demonstrated to benefit one's emotions in a 'non-judgement' way. Evidence suggests that VR-based mindfulness practice may help individuals maintain present-moment awareness and block out distractions and may be more effective than conventional mindfulness approaches. The current pilot study aims to test the feasibility and acceptability of VR-based mindfulness practices in graduate students.

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:

1. To investigate the feasibility and acceptability of the VR-based mindfulness practice in improving stress for graduate students

2. To investigate the preliminary effects of VR-based mindfulness practice in improving stress for graduate students

3. To understand the user experience of mindfulness practice in VR

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 45
• Est. completion date: January 2024
• Est. primary completion date: December 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. aged 18 or over;

2. enrolled in graduate programme at the Chinese University of Hong Kong;

3. experienced stress: the score of perceived stress scale more than 13;

4. able to speak and write in English

Exclusion Criteria:

1. diagnosed with psychiatric disorders;

2. currently taking psychotropic medication;

3. have history of photosensitive epilepsy or previous experience of severe simulator sickness;

4. 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

5. history of seizures and motion sickness.

Related Conditions & MeSH terms

• Mindfulness
• Stress
• Student
• Virtual Reality

Intervention

Other:
• Virtual reality-supported mindfulness
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.
• Mindfulness
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.

Locations

Country	Name	City	State
China	The Chinese University of Hong Kong	Hong Kong	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Acceptability of the intervention	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.	Week 2
Primary	Eligibility rate	The eligibility rate is defined as the percentage of participants fulfilling the inclusion criteria amongst the participants screened for the eligibility	Baseline
Primary	Recruitment rate	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
Primary	Attrition rate	The attrition rate is defined as the percentage of participants who withdrew from the study before completion	Week 2
Primary	Adherence rate	The adherence rate is defined as the frequency of the practice of mindfulness and session attendance	Week 2
Primary	Change from baseline in the score of perceived stress assessed by The Perceived Stress Scale to immediately after the intervention	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)
Secondary	Change from baseline in the score of mindfulness assessed by The Five Facet Mindfulness Questionnaire to immediately after the intervention	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.	Baseline and Week 2 (post-intervention)
Secondary	Change from baseline in the level of mood states by The abbreviated Profile of Mood States to immediately after the intervention	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.	Baseline and Week 2 (post-intervention)