Randomised controlled trial of VR-based observation meditation with AI coaching ('Otti') for stress reduction in university students in the United States: study protocol.
Jiheun Hong, Christopher R Shelton, Hayoung Oh
BMJ Open October 23, 2025 DOI: 10.1136/bmjopen-2024-097236 (opens in new tab)
Study at a glance
AI-extracted from the abstract| Characteristics | Randomized controlled trial Peer reviewed |
|---|---|
| Sample size | 34 |
| Population | University students in Pennsylvania, United States |
| Duration | Single 15-minute session within a 30-minute visit |
| Topics | Meditation |
| Keywords | Randomized controlled trial Stress, physiological Virtual reality |
| Registration | NCT06704282 |
| Key findings | The protocol describes a planned trial; no results are reported. |
Abstract
Stress is a major health issue in contemporary society, and mindfulness-based approaches reduce stress and anxiety but face practical barriers to consistent practice; this protocol evaluates a Virtual Reality (VR)-based observation meditation programme with an artificial intelligence (AI) coach ('Otti') that delivers real-time empathic, tailored prompts to support present-focused attention and emotion regulation in university students in the United States. A single-centre randomised controlled trial in Pennsylvania will assess immediate psychophysiological effects and user acceptability after a single 15 min session following a standardised Stroop stressor in a university laboratory setting. An a priori power analysis (f=0.25, α=0.05, power=0.80) supports recruitment of 34 students (n=17 per group) in a single-centre randomised controlled design comparing AI-coached VR observation meditation to a no-treatment leisure control within a 30 min visit. Participants complete pre-intervention surveys Perceived Stress Scale-10 (PSS-10), Depression Anxiety Stress Scales (DASS-21), State-Trait Anxiety Inventory (STAI-State, STAI-Trait) and baseline heart rate/Heart Rate Variability (HRV) via smartwatch, undergo the 15 min intervention or control, then complete postintervention surveys and repeated heart rate/HRV recording; effects will be tested using repeated-measures analysis of variance, with heart-rate data exported and preprocessed per the prespecified plan. Primary outcomes include perceived stress (PSS-10), emotional state (DASS-21, STAI-State, STAI-Trait), physiological stress response (heart rate/HRV) and participant satisfaction via a structured postintervention survey (usability, perceived effectiveness, comfort). The study received IRB approval from The Pennsylvania State University Institutional Review Board (PSU CATS IRB: STUDY00025978; ClinicalTrials.gov: NCT06704282), and all participants will provide written informed consent prior to procedures. Findings will be disseminated via open access publication, conference presentations and stakeholder-focused briefs, with an anonymised primary-outcome dataset available on reasonable request in line with BMJ Open policies and Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT)/International Committee of Medical Journal Editors (ICMJE) guidance. NCT06704282.
Comparable studies
Other randomized controlled trials on meditation, most cited first.
| Study | Year | Design | Participants |
|---|---|---|---|
| Alterations in Brain and Immune Function Produced by Mindfulness Meditation Healthy employees in a work environment | 2003 | Randomized controlled trial | n = 41 |
| Prevention of relapse/recurrence in major depression by mindfulness-based cognitive therapy. Recovered recurrently depressed patients | 2000 | Randomized controlled trial | n = 145 |
| Open hearts build lives: Positive emotions, induced through loving-kindness meditation, build consequential personal resources. Working adults | 2008 | Randomized controlled trial | n = 139 |
| Short-term meditation training improves attention and self-regulation Undergraduate Chinese students | 2007 | Randomized controlled trial | n = 40 |
| Mindfulness-Based Cognitive Therapy for Depression: Replication and Exploration of Differential Relapse Prevention Effects. Recovered recurrently depressed patients | 2004 | Randomized controlled trial | n = 73 |
Citations in the library
Cites 9
- Alterations in Brain and Immune Function Produced by Mindfulness Meditation Psychosomatic Medicine July 1, 2003
- Mindfulness-Based Stress Reduction for Stress Management in Healthy People: A Review and Meta-Analysis The Journal of Alternative and Complementary Medicine May 1, 2009
- The Effect of Mindfulness-based Programs on Cognitive Function in Adults: A Systematic Review and Meta-analysis Neuropsychology Review August 4, 2021
- The effect of ten versus twenty minutes of mindfulness meditation on state mindfulness and affect. Scientific Reports November 24, 2023
- Examining the Use of Virtual Reality to Support Mindfulness Skills Practice in Mood and Anxiety Disorders: Mixed Methods Study. Journal of Medical Internet Research December 6, 2024
and 4 more in the library