An interventional study of Oculus GO VR HMD, application Happy Place (© Mimerse) and iPad, application Happy Place (© Mimerse) in Amplified Musculoskeletal Pain Syndrome, Reflex Sympathetic Dystrophy and Complex Regional Pain Syndromes, sponsored by Tufts Medical Center. Completed at 1 site in United States. Open to participants aged 13 Years to 17 Years. Per ClinicalTrials.gov, last updated 2021-01-26.
Sponsored by Tufts Medical Center · Not applicable, Interventional, and Treatment
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.
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.
493 studies on the registry are indexed under Musculoskeletal Pain; 113 are open to participants now.
This study's enrollment of 30 is below the median of 69 across 346 interventional studies indexed under Musculoskeletal Pain.
Browse Musculoskeletal Pain studies →Tufts Medical Center is the lead sponsor of 194 studies on the registry; 28 are open to participants now.
Of its 30 completed or terminated interventional studies of FDA-regulated products, 16 (53%) have results posted.
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Exclusion Criteria:
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)
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).
The Entertainment Software Rating Board (ESRB) has rated Happy Place as 'E' ('Everyone' or content suitable for all ages).
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.
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.
Mean Change in Pain Catastrophizing Reported on Pain Catastrophizing Scale - Child (PCS-C)
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.
Mean Change in Self-efficacy to Manage Pain Reported on Self-Efficacy Scale for Child Functioning (SES-C)
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.
| Milestone | Oculus GO VR HMD, Application Happy Place (© Mimerse) | iPad, Application Happy Place (© Mimerse) |
|---|---|---|
| Started | 16 | 14 |
| Completed | 16 | 14 |
| Not completed | 0 | 0 |
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.
| units on a scale | Oculus GO VR HMD, Application Happy Place (© Mimerse) | iPad, Application Happy Place (© Mimerse) |
|---|---|---|
| The Mean Change in Pain Intensity Reported on Visual Analog Scale (VAS) | -14.9 (-22.9 to -6.9) | -9.6 (-14.3 to -4.9) |
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.
| units on a scale | Oculus GO VR HMD, Application Happy Place (© Mimerse) | iPad, Application Happy Place (© Mimerse) |
|---|---|---|
| Mean Change in Pain Catastrophizing Reported on Pain Catastrophizing Scale - Child (PCS-C) | -2.0 (-4.1 to -0.1) | -2.9 (-5.9 to -0.2) |
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.
| units on a scale | Oculus GO VR HMD, Application Happy Place (© Mimerse) | iPad, Application Happy Place (© Mimerse) |
|---|---|---|
| Mean Change in Self-efficacy to Manage Pain Reported on Self-Efficacy Scale for Child Functioning (SES-C) | -0.7 (-1.2 to -0.1) | -2.4 (-4.6 to -0.2) |
Collected over 2 days after the session for each participant.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Oculus GO VR HMD, Application Happy Place (© Mimerse) | 0/16 (0%) | 0/16 (0%) | 9/16 (56.3%) |
| iPad, Application Happy Place (© Mimerse) | 0/14 (0%) | 0/14 (0%) | 5/14 (35.7%) |
| Event | Oculus GO VR HMD, Application Happy Place (© Mimerse) | iPad, Application Happy Place (© Mimerse) |
|---|---|---|
| HeadacheGeneral disorders | 4/16 | 2/14 |
| DizzinessGeneral disorders | 3/16 | 1/14 |
| NauseaGeneral disorders | 2/16 | 2/14 |
| Age, Continuous(years) | Oculus GO VR HMD, Application Happy Place (© Mimerse) | iPad, Application Happy Place (© Mimerse) | Total |
|---|---|---|---|
| Mean | 15.7 ± 1.1 | 15.4 ± 1.5 | 15.6 ± 1.3 |
| Sex: Female, Male(Participants) | Oculus GO VR HMD, Application Happy Place (© Mimerse) | iPad, Application Happy Place (© Mimerse) | Total |
|---|---|---|---|
| Female | 13 | 12 | 25 |
| Male | 3 | 2 | 5 |
| Ethnicity (NIH/OMB)(Participants) | Oculus GO VR HMD, Application Happy Place (© Mimerse) | iPad, Application Happy Place (© Mimerse) | Total |
|---|---|---|---|
| Hispanic or Latino | 3 | 5 | 8 |
| Not Hispanic or Latino | 13 | 9 | 22 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Oculus GO VR HMD, Application Happy Place (© Mimerse) | iPad, Application Happy Place (© Mimerse) | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 1 | 1 | 2 |
| White | 12 | 10 | 22 |
| More than one race | 3 | 3 | 6 |
| Unknown or Not Reported | 0 | 0 | 0 |
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