StudentNCT05948280
Virtual Reality (VR) Based Mindfulness Practice in Relieving Stress in Postgraduate Students
A study testing Virtual reality-supported mindfulness and Mindfulness in people with Student and Stress, run by Chinese University of Hong Kong at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Student, Stress, Virtual Reality
- What is being tested?
- Virtual reality-supported mindfulness and Mindfulness
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteChina
- Study dates
- Aug 2023to Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
The Chinese University of Hong Kong
Hong Kong, Hong Kong, 999077
Huiyuan LI, PhD, 52665977, huiyuanli@cuhk.edu.hk
About this study
Official title: Virtual Reality-supported Mindfulness Practice in Relieving Stress in Postgraduate Students: a Pilot Randomised Controlled Trial
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.
Read the 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
- Conditions
- Student, Stress, Virtual Reality, Mindfulness
- Being tested
- Virtual reality-supported mindfulness, Mindfulness
- Keywords
- graduate student, stress, mental health, mindfulness, virtual reality
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual reality-supported mindfulnessOther
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.
MindfulnessOther
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.
| Study group | Role | What they receive |
|---|---|---|
| VR-supported mindfulness group | Experimental | 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. Receives: Other: Virtual reality-supported mindfulness |
| Mindfulness group | Active comparator | Participants in this group will receive a mindfulness exercise guided by the interventionist twice a week for two weeks. Receives: Other: Mindfulness |
| Control group | No intervention | Participants in the control group will not receive mindfulness or mindfulness plus VR. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eligibility rate
The eligibility rate is defined as the percentage of participants fulfilling the inclusion criteria amongst the participants screened for the eligibility
Measured: Baseline
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
Measured: Baseline
Attrition rate
The attrition rate is defined as the percentage of participants who withdrew from the study before completion
Measured: Week 2
Adherence rate
The adherence rate is defined as the frequency of the practice of mindfulness and session attendance
Measured: Week 2
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.
Measured: Baseline and Week 2 (post-intervention)
Secondary outcomes (2)
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.
Measured: Baseline and Week 2 (post-intervention)
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.
Measured: Baseline and Week 2 (post-intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2023
- Study startAug 2023 (estimated)
- Primary completionDec 2023 (estimated)
- Study completionJan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StudentStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Huiyuan LI, Chinese University of Hong Kong
- Investigators
- Cho Lee WONG, PhD, Study director, The Nethersole School of Nursing, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05948280
- Sponsor's protocol ID
- CREC Ref. No. 2023.216
- Status last verified
- Jul 2023
- First submitted
- 5 Jul 2023
- Last updated
- 17 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Reality-supported Mindfulness Practice in Relieving Stress in Postgraduate Students: a Pilot Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT05948280
- Acronym / sponsor ID
- CREC Ref. No. 2023.216
- Conditions
- Student, Stress, Virtual Reality, Mindfulness
- Keywords
- graduate student, stress, mental health, mindfulness, virtual reality
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- Aug 2023 (estimated)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Jan 2024 (estimated)
- First posted
- 17 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| VR-supported mindfulness group | Experimental | Other: Virtual reality-supported mindfulnessParticipants 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. |
| Mindfulness group | Active comparator | Other: MindfulnessParticipants in this group will receive a mindfulness exercise guided by the interventionist twice a week for two weeks. |
| Control group | No intervention | –Participants in the control group will not receive mindfulness or mindfulness plus VR. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual reality-supported mindfulnessA 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. | Other | VR-supported mindfulness group |
| MindfulnessThe 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. | Other | Mindfulness group |
Primary outcome
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
Recruitment rate
Time frame: Baseline
The recruitment rate is defined as the percentage of participants who consented to participate in the study amongst the participants eligible for the study
Attrition rate
Time frame: Week 2
The attrition rate is defined as the percentage of participants who withdrew from the study before completion
Adherence rate
Time frame: Week 2
The adherence rate is defined as the frequency of the practice of mindfulness and session attendance
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)
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.
2 secondary outcomes
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)
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cho Lee WONG, PhD study director
The Nethersole School of Nursing, Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual reality-supported mindfulness and Mindfulness in people with Student and Stress, run by Chinese University of Hong Kong at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Huiyuan LI, PhD (52665977, huiyuanli@cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Eligibility rate (time frame: Baseline). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2023.