Audio-Visual Relaxation Technology for Pediatric Amplified Musculoskeletal Pain Syndrome
CompletedNot applicableNCT03762213
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- Audio-Visual Relaxation Technology for Pediatric Amplified Musculoskeletal Pain Syndrome: A Pilot Randomized Controlled Trial
- Conditions
- Amplified Musculoskeletal Pain Syndrome
- Reflex Sympathetic Dystrophy
- Complex Regional Pain Syndromes
- Interventions
- Device: Oculus GO VR HMD, application Happy Place (© Mimerse)
- Device: iPad, application Happy Place (© Mimerse)
- Sponsor
- Tufts Medical Center
- Start date
- 2018-12-20
- Primary completion
- 2019-08-29
- Sex
- All
- Age range
- from 13 Years to 17 Years
- Results posted
- Yes, on ClinicalTrials.gov
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: 1. A diagnosis of AMPS, including CRPS, or localized or diffuse amplified pain syndrome as determined by the primary pediatric rheumatologist and coded in EMR. 2. Informed consent for caregivers and child assent for participants. Exclusion Criteria: 1. An underlying organic cause can explain the pain including inflammatory, infectious, traumatic or malignant etiologies as determined by the primary pediatric rheumatologist. 2. Participant or caregiver report of any history of motion sickness, underlying epilepsy, severe headaches in the participant or other conditions where the use of visual exposures to stimuli is contraindicated. 3. Inability to report a pain score and/or incapacity to give assent due to intellectual deficit. 4. Blindness. 5. Non-English-speaking subjects will be excluded due to the unavailability of the content of the VR application used in this study in languages other than English. 6. Any other condition that the investigators think can compromise the integrity of the study or subject safety.
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT03762213