CompletedNot Applicable

Audio-Visual Relaxation Technology for Pediatric Amplified Musculoskeletal Pain Syndrome

United States30 participantsStarted 2018-12-20

Plain-language 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.

Who can participate

Age range13 Years – 17 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. A diagnosis of AMPS, including CRPS, or localized or diffuse amplified pain syndrome as determined by the primary pediatric rheumatologist and coded in EMR.
✓. Informed consent for caregivers and child assent for participants.

Exclusion criteria

✕. An underlying organic cause can explain the pain including inflammatory, infectious, traumatic or malignant etiologies as determined by the primary pediatric rheumatologist.
✕. 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.
✕. Inability to report a pain score and/or incapacity to give assent due to intellectual deficit.
✕. Blindness.
✕. 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.
✕. Any other condition that the investigators think can compromise the integrity of the study or subject safety.

What they're measuring

The Mean Change in Pain Intensity Reported on Visual Analog Scale (VAS)

Timeframe: VAS will be administered at 5 minutes before the relaxation session, 5 minutes after the session and then at day 2 after the session in both groups.

Trial details

NCT IDNCT03762213

SponsorTufts Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-08-29

Results submitted2020-11-09

View on ClinicalTrials.gov More Amplified Musculoskeletal Pain Syndrome trials