NCT05948280

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 5, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

July 17, 2023

Completed
15 days until next milestone

Study Start

First participant enrolled

August 1, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2024

Completed
Last Updated

July 17, 2023

Status Verified

July 1, 2023

Enrollment Period

4 months

First QC Date

July 5, 2023

Last Update Submit

July 13, 2023

Conditions

Keywords

graduate studentstressmental healthmindfulnessvirtual reality

Outcome Measures

Primary Outcomes (5)

  • Eligibility rate

    The eligibility rate is defined as the percentage of participants fulfilling the inclusion criteria amongst the participants screened for the eligibility

    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

    Baseline

  • Attrition rate

    The attrition rate is defined as the percentage of participants who withdrew from the study before completion

    Week 2

  • Adherence rate

    The adherence rate is defined as the frequency of the practice of mindfulness and session attendance

    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.

    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

    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

    Baseline and Week 2 (post-intervention)

Other Outcomes (1)

  • Acceptability of the intervention

    Week 2

Study Arms (3)

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.

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.

Other: Mindfulness

Control group

NO INTERVENTION

Participants in the control group will not receive mindfulness or mindfulness plus VR.

Interventions

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.

VR-supported mindfulness group

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.

Mindfulness group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Chinese University of Hong Kong

Hong Kong, Hong Kong, 999077, China

Location

MeSH Terms

Conditions

Psychological Well-Being

Interventions

Mindfulness

Condition Hierarchy (Ancestors)

Personal SatisfactionBehavior

Intervention Hierarchy (Ancestors)

Cognitive Behavioral TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Cho Lee WONG, PhD

    The Nethersole School of Nursing, Chinese University of Hong Kong

    STUDY DIRECTOR

Central Study Contacts

Huiyuan LI, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The outcomes assessor who is independent of the research will be trained before formally conducting data collecting.
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Postdoctoral Fellow

Study Record Dates

First Submitted

July 5, 2023

First Posted

July 17, 2023

Study Start

August 1, 2023

Primary Completion

December 1, 2023

Study Completion

January 1, 2024

Last Updated

July 17, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations