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Audio-Visual Relaxation Technology for Pediatric Amplified Musculoskeletal Pain Syndrome

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ClinicalTrials.gov Identifier: NCT03762213
Recruitment Status : Recruiting
First Posted : December 3, 2018
Last Update Posted : December 25, 2018
Sponsor:
Information provided by (Responsible Party):
Tufts Medical Center

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.

Condition or disease Intervention/treatment Phase
Amplified Musculoskeletal Pain Syndrome Reflex Sympathetic Dystrophy Complex Regional Pain Syndromes Device: Oculus GO VR HMD, application Happy Place (© Mimerse) Device: iPad, application Happy Place (© Mimerse) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Audio-Visual Relaxation Technology for Pediatric Amplified Musculoskeletal Pain Syndrome: A Pilot Randomized Controlled Trial
Actual Study Start Date : December 20, 2018
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Oculus GO VR HMD, application Happy Place (© Mimerse)

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

Placebo Comparator: iPad, application Happy Place (© Mimerse)
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)
The Entertainment Software Rating Board (ESRB) has rated Happy Place as 'E' ('Everyone' or content suitable for all ages).




Primary Outcome Measures :
  1. The mean change in pain intensity reported on Visual Analog Scale (VAS) [ Time Frame: 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. ]
    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.


Secondary Outcome Measures :
  1. Mean change in pain catastrophizing reported on Pain Catastrophizing Scale - Child (PCS-C) [ Time Frame: PCS-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. ]
    The Pain Catastrophizing Scale -Child (PCS-C) is an adaptation of the Pain Catastrophizing Scale with established construct and predictive validity in 8-16 years old subjects. It is a self-report measure which includes 13 items about the thoughts and feelings experienced when a child is in pain. Respondents use a 5-point rating scale (where 0 = never to 4 = always), to indicate how often they experience each thought or feeling. The total score for the PCS equals 52, with a score above 24 indicating a high score. The lowest score can be 0. Higher score represents worse outcome. PCS-C scale has three sub-scales namely, rumination, magnification, and helplessness. The investigators will not assess the sub-scales as a part of this study.


Other Outcome Measures:
  1. Mean change in self-efficacy to manage pain reported on Self-Efficacy Scale for Child Functioning (SES-C) [ Time Frame: 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. ]
    The Self-Efficacy Scale for Child Functioning (SES-C) is a reliable and validated self-efficacy measure for children 9-18 years of age with chronic pain. The child version has established psychometric properties, excellent reliability and strong evidence for construct validity. It consists of 7 Likert scale questions with a range from very sure (=1) to very unsure (=5). The lowest score can be 7, which reflects highest self-efficacy to manage pain, and the highest score can be 35, which corresponds to lowest self-efficacy to manage pain. Higher score represents worse outcome. It has no sub-scales.



Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03762213


Contacts
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Contact: Saumya V Joshi, MD 6176365071 sjoshi3@tuftsmedicalcenter.org
Contact: Trevor E Davis, MD 6176365071 tdavis2@tuftsmedicalcenter.org

Locations
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United States, Massachusetts
Tufts Medical Center Recruiting
Boston, Massachusetts, United States, 02111
Contact: Saumya V Joshi, MD    617-636-5071    sjoshi3@tuftsmedicalcenter.org   
Contact: Davis Trevor, MD    6176365071    tdavis2@tuftsmedicalcenter.org   
Sponsors and Collaborators
Tufts Medical Center
Investigators
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Principal Investigator: Trevor E Davis, MD Tufts Medical Center

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Responsible Party: Tufts Medical Center
ClinicalTrials.gov Identifier: NCT03762213     History of Changes
Other Study ID Numbers: 13135
First Posted: December 3, 2018    Key Record Dates
Last Update Posted: December 25, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:
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Complex Regional Pain Syndromes
Reflex Sympathetic Dystrophy
Syndrome
Somatoform Disorders
Musculoskeletal Pain
Chronic Pain
Disease
Pathologic Processes
Mental Disorders
Muscular Diseases
Musculoskeletal Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
Autonomic Nervous System Diseases
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases