Audio-Visual Relaxation Technology for Pediatric Amplified Musculoskeletal Pain Syndrome

• Sponsor: Tufts Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT03762213
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arms: 2
• Actual Duration (Months): 8.3
• Patients Per Site Per Month: 3.6

Study Details

Study Description

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)	N/A

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 Design

• Study Type: Interventional
• Actual 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.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: Dec 20, 2018
• Actual Primary Completion Date: Aug 29, 2019
• Actual Study Completion Date: Aug 29, 2019

Arms and Interventions

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).

Outcome Measures

Primary Outcome Measures

1. The Mean Change in Pain Intensity Reported on Visual Analog Scale (VAS) [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) [PCS-C will be administered at 5 minutes before the relaxation session, 5 minutes after the session and day 2 after the study.]

   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. The outcome measure will be reported as the mean difference in post-intervention score (assessed 5 minutes after the session) minus pre-intervention score (assessed 5 minuets before the session) for both groups with the 95% confidence interval.

Other Outcome Measures

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.]

   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. The outcome measure will be reported as the mean difference in post-intervention score (assessed 5 minutes after the session) minus pre-intervention score (assessed 5 minuets before the session) for both groups with the 95% confidence interval.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 13 Years to 17 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Tufts Medical Center	Boston	Massachusetts	United States	02111

Sponsors and Collaborators

• Tufts Medical Center

Investigators

• Principal Investigator: Trevor E Davis, MD, Tufts Medical Center

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Nov 15, 2018

More Information

Publications

None provided.

• Responsible Party: Tufts Medical Center
• ClinicalTrials.gov Identifier: NCT03762213
• Other Study ID Numbers: 13135
• First Posted: Dec 3, 2018
• Last Update Posted: Jan 26, 2021
• Last Verified: Jan 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: Yes
• Additional relevant MeSH terms: Musculoskeletal Pain; Complex Regional Pain Syndromes; Reflex Sympathetic Dystrophy; Syndrome; Chronic Pain; Somatoform Disorders

Study Results

Participant Flow

Arm/Group Title	Oculus GO VR HMD, Application Happy Place (© Mimerse)	iPad, Application Happy Place (© Mimerse)
Arm/Group Description	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. 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).	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. iPad, application Happy Place (© Mimerse): The Entertainment Software Rating Board (ESRB) has rated Happy Place as 'E' ('Everyone' or content suitable for all ages).
Period Title: Overall Study
STARTED	16	14
COMPLETED	16	14
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Oculus GO VR HMD, Application Happy Place (© Mimerse)	iPad, Application Happy Place (© Mimerse)	Total
Arm/Group Description	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. 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).	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. iPad, application Happy Place (© Mimerse): The Entertainment Software Rating Board (ESRB) has rated Happy Place as 'E' ('Everyone' or content suitable for all ages).	Total of all reporting groups
Overall Participants	16	14	30
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	15.7 (1.1)	15.4 (1.5)	15.6 (1.3)
Sex: Female, Male (Count of Participants)
Female	13 81.3%	12 85.7%	25 83.3%
Male	3 18.8%	2 14.3%	5 16.7%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	3 18.8%	5 35.7%	8 26.7%
Not Hispanic or Latino	13 81.3%	9 64.3%	22 73.3%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	1 6.3%	1 7.1%	2 6.7%
White	12 75%	10 71.4%	22 73.3%
More than one race	3 18.8%	3 21.4%	6 20%
Unknown or Not Reported	0 0%	0 0%	0 0%

Outcome Measures

1. Primary Outcome

Title	The Mean Change in Pain Intensity Reported on Visual Analog Scale (VAS)
Description	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.
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.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Oculus GO VR HMD, Application Happy Place (© Mimerse)	iPad, Application Happy Place (© Mimerse)
Arm/Group Description	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. 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).	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. iPad, application Happy Place (© Mimerse): The Entertainment Software Rating Board (ESRB) has rated Happy Place as 'E' ('Everyone' or content suitable for all ages).
Measure Participants	16	14
Mean (95% Confidence Interval) [units on a scale]	-14.9	-9.6

2. Secondary Outcome

Title	Mean Change in Pain Catastrophizing Reported on Pain Catastrophizing Scale - Child (PCS-C)
Description	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. The outcome measure will be reported as the mean difference in post-intervention score (assessed 5 minutes after the session) minus pre-intervention score (assessed 5 minuets before the session) for both groups with the 95% confidence interval.
Time Frame	PCS-C will be administered at 5 minutes before the relaxation session, 5 minutes after the session and day 2 after the study.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Oculus GO VR HMD, Application Happy Place (© Mimerse)	iPad, Application Happy Place (© Mimerse)
Arm/Group Description	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. 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).	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. iPad, application Happy Place (© Mimerse): The Entertainment Software Rating Board (ESRB) has rated Happy Place as 'E' ('Everyone' or content suitable for all ages).
Measure Participants	16	14
Mean (95% Confidence Interval) [units on a scale]	-2.0	-2.9

3. Other Pre-specified Outcome

Title	Mean Change in Self-efficacy to Manage Pain Reported on Self-Efficacy Scale for Child Functioning (SES-C)
Description	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. The outcome measure will be reported as the mean difference in post-intervention score (assessed 5 minutes after the session) minus pre-intervention score (assessed 5 minuets before the session) for both groups with the 95% confidence interval.
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.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Oculus GO VR HMD, Application Happy Place (© Mimerse)	iPad, Application Happy Place (© Mimerse)
Arm/Group Description	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. 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).	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. iPad, application Happy Place (© Mimerse): The Entertainment Software Rating Board (ESRB) has rated Happy Place as 'E' ('Everyone' or content suitable for all ages).
Measure Participants	16	14
Mean (95% Confidence Interval) [units on a scale]	-0.7	-2.4

Adverse Events

Time Frame	2 days after the session for each participant.
Arm/Group Title	Oculus GO VR HMD, Application Happy Place (© Mimerse)		iPad, Application Happy Place (© Mimerse)
Arm/Group Description	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. 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).		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. iPad, application Happy Place (© Mimerse): The Entertainment Software Rating Board (ESRB) has rated Happy Place as 'E' ('Everyone' or content suitable for all ages).
All Cause Mortality
	Oculus GO VR HMD, Application Happy Place (© Mimerse)		iPad, Application Happy Place (© Mimerse)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/16 (0%)		0/14 (0%)
Serious Adverse Events
	Oculus GO VR HMD, Application Happy Place (© Mimerse)		iPad, Application Happy Place (© Mimerse)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/16 (0%)		0/14 (0%)
Other (Not Including Serious) Adverse Events
	Oculus GO VR HMD, Application Happy Place (© Mimerse)		iPad, Application Happy Place (© Mimerse)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	9/16 (56.3%)		5/14 (35.7%)
General disorders
Dizziness	3/16 (18.8%)		1/14 (7.1%)
Nausea	2/16 (12.5%)		2/14 (14.3%)
Headache	4/16 (25%)		2/14 (14.3%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.