Status:
COMPLETED
Audio-Visual Relaxation Technology for Pediatric Amplified Musculoskeletal Pain Syndrome
Lead Sponsor:
Tufts Medical Center
Conditions:
Amplified Musculoskeletal Pain Syndrome
Reflex Sympathetic Dystrophy
Eligibility:
All Genders
13-17 years
Phase:
NA
Brief 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 ...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 20 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 29 2019
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT03762213
Start Date
December 20 2018
End Date
August 29 2019
Last Update
January 26 2021
Active Locations (1)
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1
Tufts Medical Center
Boston, Massachusetts, United States, 02111