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Positive with limitationsSingle-blind two-arm randomized pilot feasibility and acceptability trial

Feasibility and Acceptability of Perioperative Application of Biofeedback-Based Virtual Reality vs Control for Pain and Anxiety in Children and Adolescents Undergoing Surgery: Pilot Randomized Controlled Trial.

A respiratory-biofeedback VR program was practical and generally well accepted among adolescents around surgery. The pilot was designed to test feasibility, not whether it reduced pain or anxiety better than the control app.

Lin AM, Rachwal B, Asti L, Orgil Z, Santiago I, Ding L, Kashikar-Zuck S, King CD, Williams SE, Black WR, Minneci PC, Olbrecht VA.
Journal of medical Internet research · Publication date: 2026-09-16
Added to site: 2026-09-20
DOI: 10.2196/94604

Electronic publication date verified in Europe PMC and the full-text journal record.

Modalities
Biofeedback, HRV biofeedback, Virtual reality
Clinical focus
Pediatric surgery, Pain and anxiety, Feasibility
Population
Patients ages 12 to 18 undergoing surgery with expected moderate-to-severe postoperative pain and more than one overnight admission
Sample
70 adolescents enrolled; 65 completed, including 30 in VR biofeedback and 35 in the active-control group
Intervention / method
Respiratory biofeedback embedded in immersive VR before and after surgery, with breathing controlling game actions and real-time heart and respiratory sensing; the control used the Manage My Pain app
Comparator
Active digital pain-monitoring app without biofeedback, immersive VR or physiologic self-regulation

Clinician summary

Sixty-five of 70 randomized participants completed the study, and 28 of 30 VR-biofeedback completers said they would use it again. Six reported mild transient adverse events and none was serious. Exploratory one-point symptom changes were within-group observations rather than a comparative efficacy result.

How to interpret the findings

The trial was not powered for between-group clinical efficacy, enrolled heterogeneous procedures, and assessed exploratory symptoms only in the intervention group. A demanding schedule, first-generation hardware problems, retrospective acceptability ratings and technology-receptive volunteers may limit adherence and generalizability.

Equipment and disclosures

ForeVR combined Bluetooth-integrated heart- and respiratory-rate sensing with a Meta Quest headset and a proprietary breathing-controlled virtual-reality game. This is study-specific technology, not BrainMaster equipment.

NIH NCCIH award R34AT011218 supported the study. Three authors were ForeVR coinventors with ownership or advisory roles in Biofeedback VRx, LLC; a conflict-management plan was reported. The authors also disclosed Microsoft Enterprise Copilot use for language editing.

Related evidence

Compare findings from the same clinical area, including mixed results.

Full text checked · Checked 2026-09-20

Summary prepared with AI assistance. Source verification does not imply an independent replication or a clinician's endorsement. Read our review method.