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Not yet recruiting NCT07108556

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

No phase Interventional Mental Wellbeing

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Mindfulness VR-Typical, Mindfulness Typical-VR.
Who it may be relevant to
Registry conditions: Mental Wellbeing. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Hong Kong
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Brief Mindfulness Workshop With or Without Virtual Reality: A Randomized Crossover Design

Overview

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.

Interventions

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

Primary outcome measures

  • Change in positive affect as measured by International Positive and Negative Affect Schedule Short Form (I-PANAS-SF) after a brief practice of mindfulness. [Time frame: 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. [Time frame: 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. [Time frame: 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. [Time frame: 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. [Time frame: 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 outcome measures (1)
  • Satisfaction with the intervention as measured by a single Likert item with open text entry designed specifically for this study [Time frame: At the end of the full program (i.e., one-time assessment; at minute 20).]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Crossover
Masking
Single blind
Primary purpose
Treatment

Study locations

Hong Kong · 1 center
  • New Life Psychiatric Rehabilitation Association — Kowloon

Identifiers

NCT: NCT07108556 · EA250376

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗