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Audio-Visual Relaxation Technology for Pediatric Amplified Musculoskeletal Pain Syndrome

NCT03762213 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2021-01-26

Study results available
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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.

Conditions

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

Interventions

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).

Sponsors & Collaborators

  • Tufts Medical Center

    lead OTHER

Principal Investigators

  • Trevor E Davis, MD · Tufts Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
13 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-20
Primary Completion
2019-08-29
Completion
2019-08-29
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03762213 on ClinicalTrials.gov