Effect of virtual reality-integrated mindfulness-based cognitive therapy on pain and psychological symptoms in chronic non-specific low back pain: protocol for a randomized controlled trial.
Panqi Wang, Junpeng Yuan, Qin Gu, Guoyang Dai, Xinran Zhu, Zhenxiu Liu, Youjia Yu, Xiaohong Jin
Frontiers in Digital Health July 31, 2026 DOI: 10.3389/fdgth.2026.1902063 (opens in new tab)
Study at a glance
AI-extracted from the abstract| Characteristics | Randomized controlled trial protocol Open-label Peer reviewed |
|---|---|
| Sample size | 214 |
| Population | Adults with chronic non-specific low back pain recruited from pain clinics of three hospitals |
| Intervention | usual care |
| Duration | 8-week intervention, with assessments at baseline, week 4, week 8, and week 26 |
| Measures | Oswestry Disability Index (ODI), 0-10 back pain bothersomeness scale |
| Topics | Meditation |
| Keywords | Virtual reality Mindfulness-based cognitive therapy Oswestry disability index Back pain bothersomeness |
| Registration | NCT07589790 |
| Key findings | The protocol proposes that an 8-week VR-integrated MBCT program, added to usual care, may improve functional disability and back pain bothersomeness in patients with chronic non-specific low back pain, and aims to assess its efficacy and safety. No results are reported; the trial is planned with 214 participants and a 30% improvement threshold on the Oswestry Disability Index and a 0-10 bothersomeness scale at week 8. |
Abstract
Background: Chronic non-specific low back pain (CNLBP) is a common condition associated with persistent pain, functional limitation, reduced quality of life, and substantial healthcare and socioeconomic burden. Mindfulness-based cognitive therapy (MBCT) has been increasingly used in chronic pain management and may provide a promising therapeutic approach for CNLBP. The emergence of virtual reality (VR) further provides an immersive, standardized, and accessible platform for delivering MBCT. This study aims to evaluate the effects and safety of a CNLBP-specific VR-integrated MBCT intervention in patients with CNLBP.
Methods: This multi-center, prospective, parallel-group, open-label randomized controlled trial will recruit 214 patients with CNLBP from the pain clinics of three hospitals. Participants will be randomly assigned in a 1:1 ratio to either an 8-week VR-MBCT group consisting of weekly in-clinic VR sessions supplemented by structured audio-guided home practice, or a usual care control group receiving usual care alone, such as pharmacotherapy and physical therapy, using stratified block randomization according to study center and age (≥60 years or <60 years), with block sizes of 2 and 4. The primary outcomes are the proportions of patients achieving at least a 30% improvement from baseline in functional disability, assessed by the Oswestry Disability Index (ODI), and in self-reported back pain bothersomeness, assessed on a 0-10 scale, at week 8. Secondary outcomes include pain intensity, anxiety, depression, sleep quality, kinesiophobia, pain catastrophizing, work productivity, system usability, and use of concomitant treatments. Safety outcomes will include VR-related adverse events, such as vertigo, vomiting and nausea, headache and falls. Assessments will be conducted at baseline, week 4, week 8, and week 26. Data will be analyzed according to the intention-to-treat principle using generalized estimating equations (GEEs).
Discussion: This study aims to provide preliminary evidence regarding the efficacy and safety of VR-integrated MBCT as an adjunct to usual care in patients with CNLBP. Clinical
Trial Registration: https://clinicaltrials.gov/ct2/show/NCT07589790, identifier NCT07589790.
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 8
- Mindfulness-based Interventions for Chronic Low Back Pain: A Systematic Review and Meta-analysis. Clinical Journal of Pain February 1, 2024
- Which type and dosage of mindfulness-based interventions are most effective for chronic pain? A systematic review and network meta-analysis. Journal of Psychosomatic Research April 1, 2025
- Enhancing Mindfulness-Based Cognitive Therapy in a Virtual Reality: A Prospective Interventional Study. Scientific Reports September 9, 2025
- Mindfulness-Based Cognitive Therapy for Treating Chronic Pain A Systematic Review and Meta-analysis Psychology, Health & Medicine November 26, 2020
- A Pilot Randomized Controlled Trial Comparing Mindfulness Meditation, Cognitive Therapy, and Mindfulness-Based Cognitive Therapy for Chronic Low Back Pain Pain Medicine November 1, 2019
and 3 more in the library