Audio-Visual Relaxation Technology for Pediatric Amplified Musculoskeletal Pain Syndrome

NCT03762213 | Completed Results FDA Device

• 1 other identifier: 13135
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

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

  The VAS is a self-reported quantitative measure of pain intensity used commonly in clinical practice as well as in pain research. The VAS is a straight horizontal line of fixed length, usually 0 mm to 100 mm where 0 denotes 'no pain' and 100 denotes 'pain as bad as it could possibly be'. The participant marks a point on the line that they feel represents the perception of their current pain. The VAS score is then determined by measuring in millimeters from the left-hand end of the line to the point that the participant marks. The primary outcome measure is is the mean change in VAS from 5 minutes before the relaxation session to 5 minutes after the session.

  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 (1)

• Mean Change in Pain Catastrophizing Reported on Pain Catastrophizing Scale - Child (PCS-C)

  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 (1)

• Mean Change in Self-efficacy to Manage Pain Reported on Self-Efficacy Scale for Child Functioning (SES-C)

  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.

Study Arms (2)

Oculus GO VR HMD, application Happy Place (© Mimerse)

EXPERIMENTAL

Oculus GO is a stand-alone, consumer-grade, virtual reality head-mounted display (HMD). The HMD is placed on the head of the user blocking off the surrounding environment. The visuals and audio are relayed through the HMD in a virtual space.Happy Place (© Mimerse) is a publicly available application with an explicit intent to be used for chronic pain patients. It has the critical elements of VR, namely immersion and interactivity. Immersion: The scene is a serene lakeside campground with guided relaxation and soothing music. The application intends to promote positive effects such as calmness and feeling of wonder. Interactivity: Happy Place uses an innovative 'gaze-based interaction' with the virtual world. Around 50 'gaze objects' are placed around the scene and gazing at them would trigger an event. The entire duration of the experience will be kept at 10 minutes.

Device: Oculus GO VR HMD, application Happy Place (© Mimerse)

iPad, application Happy Place (© Mimerse)

PLACEBO COMPARATOR

An iPad with earphones (Apple Inc. Cupertino CA) will be used for controls. The participants in control group will watch the same content for the same duration on an iPad screen (flat version of Happy Place). This experience will be different from the intervention group in two ways: first, lack of an immersive environment, and second, lack of interactivity with the environment.

Device: iPad, application Happy Place (© Mimerse)

Interventions

Oculus GO VR HMD, application Happy Place (© Mimerse) DEVICE

The Entertainment Software Rating Board (ESRB) has rated Happy Place as 'E' ('Everyone' or content suitable for all ages).

Oculus GO VR HMD, application Happy Place (© Mimerse)

iPad, application Happy Place (© Mimerse) DEVICE

The Entertainment Software Rating Board (ESRB) has rated Happy Place as 'E' ('Everyone' or content suitable for all ages).

iPad, application Happy Place (© Mimerse)

Eligibility Criteria

• Age: 13 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tufts Medical Center: lead

Study Sites (1)

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

MeSH Terms

Conditions

Chronic Pain; Reflex Sympathetic Dystrophy; Complex Regional Pain Syndromes

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Autonomic Nervous System Diseases; Nervous System Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases

Results Point of Contact

• Title: Dr. Saumya V Joshi
• Organization: Arkansas Children's Hospital

svjoshi@uams.edu

501-364-4619

Study Officials

• Trevor E Davis, MD

  Tufts Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 29, 2018
• First Posted: December 3, 2018
• Study Start: December 20, 2018
• Primary Completion: August 29, 2019
• Study Completion: August 29, 2019
• Last Updated: January 26, 2021
• Results First Posted: January 26, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)