NCT03762213

Audio-Visual Relaxation Technology for Pediatric Amplified Musculoskeletal Pain Syndrome

Audio-Visual Relaxation Technology for Pediatric Amplified Musculoskeletal Pain Syndrome: A Pilot Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Tufts Medical Center · Academic / Other
• Sex: All
• Age: 13 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

A pilot randomized controlled trial to assess feasibility, acceptability and generate outcome domains for a future RCT testing the efficacy of immersive virtual reality on pain intensity in pediatric amplified musculoskeletal pain syndrome.

Detailed description

Adolescents with amplified musculoskeletal pain syndrome (AMPS) are invited to take part in this research project that studies two different audio-visual relaxation technologies in reducing amplified musculoskeletal pain. In addition, the investigators are interested in studying if they have an effect on some of the ways adolescents think about their pain and cope with it. Both of these technologies provide the user with a similar natural environment designed to have a calming effect, along with guided relaxation and soothing music. The adolescents will be assigned to use one of these for a total duration of about 10 minutes. Pain related outcomes including pain intensity, pain catastrophizing and self-efficacy to manage pain will be collected before and after the relaxation session.

Conditions

• Amplified Musculoskeletal Pain Syndrome
• Reflex Sympathetic Dystrophy
• Complex Regional Pain Syndromes

Interventions

Type	Name	Description
DEVICE	Oculus GO VR HMD, application Happy Place (© Mimerse)	The Entertainment Software Rating Board (ESRB) has rated Happy Place as 'E' ('Everyone' or content suitable for all ages).
DEVICE	iPad, application Happy Place (© Mimerse)	The Entertainment Software Rating Board (ESRB) has rated Happy Place as 'E' ('Everyone' or content suitable for all ages).

Timeline

• Start date: 2018-12-20
• Primary completion: 2019-08-29
• Completion: 2019-08-29
• First posted: 2018-12-03
• Last updated: 2021-01-26
• Results posted: 2021-01-26

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study