Clinical trial NCT03762213: Audio-Visual Relaxation Technology for Pediatric Amplified Musculoskeletal Pain Syndrome
Official title: Audio-Visual Relaxation Technology for Pediatric Amplified Musculoskeletal Pain Syndrome: A Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Amplified Musculoskeletal Pain Syndrome
Reflex Sympathetic Dystrophy
Complex Regional Pain Syndromes
Lead sponsor: Tufts Medical Center
Sponsor class: OTHER
First posted: 2018-12-03
Enrollment: 30
Sex: ALL
Minimum age (years): 13
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The investigators propose a parallel-group pilot randomized controlled trial with a stratified block randomization and an equal allocation ratio of 1:1. The participants will be randomly allocated to Group A (VR/intervention group) or Group B (iPad/control group). The relaxation session will last for 10 minutes in each group using the same application Happy Place (© Mimerse) played on VR headsets (Oculus GO) versus iPad (Apple Inc. Cupertino CA). The randomization will be stratified on the basis of pain score on the day of intervention.
Primary purpose: TREATMENT

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 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.

Eligibility criteria: 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.

Primary outcomes:
measure: 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.
Secondary outcomes:
measure: Mean Change in Pain Catastrophizing Reported on Pain Catastrophizing Scale - Child (PCS-C)
timeFrame: PCS-C will be administered at 5 minutes before the relaxation session, 5 minutes after the session and day 2 after the study.
Other outcomes:
measure: Mean Change in Self-efficacy to Manage Pain Reported on Self-Efficacy Scale for Child Functioning (SES-C)
timeFrame: SES-C 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.
Locations:
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
Study officials:
affiliation: Tufts Medical Center
name: Trevor E Davis, MD
role: PRINCIPAL_INVESTIGATOR
References: