Brief Mindfulness Workshop With or Without Virtual Reality: A Pilot Study

NCT07108556 | Not Yet Recruiting

• 1 other identifier: EA250376
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

Brief Summary

The current study uses a randomized cross-over design, in which participants are exposed to brief mindfulness-based experiential sessions with and without incorporating virtual reality (i.e., the experimental and control conditions, respectively). Order of exposure to these two conditions are counter-balanced and participants are randomized into the two arms of exposure in a different order. Furthermore, this study includes the use of both subjective self-report and objective physiological measures of mental wellbeing. It is hypothesized that VR-incorporated mindfulness-based experiential session brings a greater improvement in state mindfulness, state affect, and stress response. Results shed light on the added value of incorporating VR into brief MBIs, particularly in reference to the typical practice of promoting mindfulness in the local community.

Conditions

Mental Wellbeing

Outcome Measures

Primary Outcomes (5)

• Change in positive affect as measured by International Positive and Negative Affect Schedule Short Form (I-PANAS-SF) after a brief practice of mindfulness.

  Using a 5-point Likert scale from 1 = Never to 5 = Always, individuals rate on their experience of five positive affect in the present moment. Scores are summed across 5 items, with higher scores indicating higher levels of positive affect.

  At the start of the first session (at minute 0), at the end of the first session (which is also the start of the second session; at minute 10), and at the end of the second session (at minute 20).

• Change in negative affect as measured by International Positive and Negative Affect Schedule Short Form (I-PANAS-SF) after a brief practice of mindfulness.

  Using a 5-point Likert scale from 1 = Never to 5 = Always, individuals rate on their experience of five negative affect in the present moment. Scores are summed across 5 items, with higher scores indicating higher levels of negative affect.

  At the start of the first session (at minute 0), at the end of the first session (which is also the start of the second session; at minute 10), and at the end of the second session (at minute 20).

• Change in state mindfulness as measured by the State Mindfulness Scale (SMS) after a brief practice of mindfulness.

  Individuals rate their state mindfulness on a 5-point Likert scale across 21 items, from 1 = Not at All to 5 = Very Much. Scores are summed to represent overall mindfulness and two subfactors differentiated by objects of mindfulness - (1) mind and (2) body. Higher scores indicate higher levels of mindfulness at the moment.

  At the start of the first session (at minute 0), at the end of the first session (which is also the start of the second session; at minute 10), and at the end of the second session (at minute 20).

• Change in heart rate variability as measured with the Shimmer3 GSR+ (Galvanic Skin Response) unit after a brief practice of mindfulness.

  The Shimmer3 GSR+ unit is strapped to a participant's wrist and fingers of the non-dominant hand. An optical pulse sensor is attached to the second finger to collect photoplethysmogram (PPG) signals over a 5-minute period, which are then transformed into HRV measures with artifacts corrected through automated detection using the Kubios HRV Scientific software. Higher values indicate greater heart rate variability.

  At the start of the first session (at minute 0), at the end of the first session (which is also the start of the second session; at minute 10), and at the end of the second session (at minute 20).

• Change in skin conductance level as measured with the Shimmer3 GSR+ (Galvanic Skin Response) unit after a brief practice of mindfulness.

  The Shimmer3 GSR+ unit is strapped to a participant's wrist and fingers of the non-dominant hand. Two additional electrodes are attached to the third and fourth fingers of the participants' non-dominant hand to collect both phasic and tonic skin conductance data. Higher values indicate greater skin conductance.

  At the start of the first session (at minute 0), at the end of the first session (which is also the start of the second session; at minute 10), and at the end of the second session (at minute 20).

Secondary Outcomes (1)

• Satisfaction with the intervention as measured by a single Likert item with open text entry designed specifically for this study

  At the end of the full program (i.e., one-time assessment; at minute 20).

Other Outcomes (1)

• Level of engagement or presence during a mindfulness exercise as measured by 3-5 Likert items designed specifically for this study

  At the start of the first session (at minute 0), at the end of the first session (which is also the start of the second session; at minute 10), and at the end of the second session (at minute 20).

Study Arms (2)

Mindfulness Add-on (with VR-incorporated first)

EXPERIMENTAL

Mindfulness exercise with virtual reality incorporated as the first experiential session

Behavioral: Mindfulness VR-Typical

Mindfulness Typical (audio-only first)

ACTIVE COMPARATOR

Mindfulness exercise with only audio guidance as the first experiential session

Behavioral: Mindfulness Typical-VR

Interventions

Mindfulness VR-Typical BEHAVIORAL

Participants first experience mindfulness exercise with virtual reality incorporated, then another mindfulness exercise with only audio-guidance as typically delivered without the technology

Mindfulness Add-on (with VR-incorporated first)

Mindfulness Typical-VR BEHAVIORAL

Participants first experience mindfulness exercise with only audio-guidance, then another mindfulness exercise with virtual reality incorporated

Mindfulness Typical (audio-only first)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• aged 18 years or older
• reads Chinese
• understands Cantonese

You may not qualify if:

• history of sever motion sickness or known intolerance to VR environments
• impairments that may interfere with the use of VR equipment
• concurrent or past structured mindfulness training

Sponsors & Collaborators

• The University of Hong Kong: lead
• New Life Psychiatric Rehabilitation Association: collaborator

Study Sites (1)

New Life Psychiatric Rehabilitation Association

Kowloon, Hong Kong

Location

Study Officials

• Amanda K Cheung

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Harry Chung

CONTACT

+852-2319-2103; harrychung@nlpra.org.hk

Peter Ho

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant Professor

Study Record Dates

• First Submitted: July 23, 2025
• First Posted: August 7, 2025
• Study Start: August 2, 2025
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: August 7, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)