Clinical trial NCT05948280: Virtual Reality (VR) Based Mindfulness Practice in Relieving Stress in Postgraduate Students
Official title: Virtual Reality-supported Mindfulness Practice in Relieving Stress in Postgraduate Students: a Pilot Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Student
Stress
Virtual Reality
Mindfulness
Keywords: graduate student
stress
mental health
mindfulness
virtual reality
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2023-07-17
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are assigned to three groups in parallel for the duration of the study. Participants in Group A receive Virtual reality-based mindfulness. Participants in Group B receive general mindfulness exercises. Participants in Group C receive no intervention as control.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

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:

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

Eligibility criteria: 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.

Primary outcomes:
measure: Eligibility rate
timeFrame: Baseline
measure: Recruitment rate
timeFrame: Baseline
measure: Attrition rate
timeFrame: Week 2
measure: Adherence rate
timeFrame: Week 2
measure: Change from baseline in the score of perceived stress assessed by The Perceived Stress Scale to immediately after the intervention
timeFrame: Baseline and Week 2 (post-intervention)
Secondary outcomes:
measure: Change from baseline in the score of mindfulness assessed by The Five Facet Mindfulness Questionnaire to immediately after the intervention
timeFrame: Baseline and Week 2 (post-intervention)
measure: Change from baseline in the level of mood states by The abbreviated Profile of Mood States to immediately after the intervention
timeFrame: Baseline and Week 2 (post-intervention)
Other outcomes:
measure: Acceptability of the intervention
timeFrame: Week 2
Locations:
city: Hong Kong
country: China
facility: The Chinese University of Hong Kong
state: Hong Kong
Study officials:
affiliation: The Nethersole School of Nursing, Chinese University of Hong Kong
name: Cho Lee WONG, PhD
role: STUDY_DIRECTOR
References: