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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

Tracking Information
First Submitted Date  ICMJE November 29, 2018
First Posted Date  ICMJE December 3, 2018
Last Update Posted Date December 25, 2018
Actual Study Start Date  ICMJE December 20, 2018
Estimated Primary Completion Date September 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 30, 2018)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03762213 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 4, 2018)
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.
Original Secondary Outcome Measures  ICMJE
 (submitted: November 30, 2018)
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. We will not assess the sub-scales as a part of this study.
Current Other Pre-specified Outcome Measures
 (submitted: November 30, 2018)
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.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Audio-Visual Relaxation Technology for Pediatric Amplified Musculoskeletal Pain Syndrome
Official Title  ICMJE Audio-Visual Relaxation Technology for Pediatric Amplified Musculoskeletal Pain Syndrome: A Pilot Randomized Controlled Trial
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE
  • Amplified Musculoskeletal Pain Syndrome
  • Reflex Sympathetic Dystrophy
  • Complex Regional Pain Syndromes
Intervention  ICMJE
  • 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).
  • 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).
Study Arms  ICMJE
  • 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.

    Intervention: Device: Oculus GO VR HMD, application Happy Place (© Mimerse)
  • 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.
    Intervention: Device: iPad, application Happy Place (© Mimerse)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 30, 2018)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2019
Estimated Primary Completion Date September 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 13 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Saumya V Joshi, MD 6176365071 sjoshi3@tuftsmedicalcenter.org
Contact: Trevor E Davis, MD 6176365071 tdavis2@tuftsmedicalcenter.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03762213
Other Study ID Numbers  ICMJE 13135
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Tufts Medical Center
Study Sponsor  ICMJE Tufts Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Trevor E Davis, MD Tufts Medical Center
PRS Account Tufts Medical Center
Verification Date December 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP