Virtual Reality Distraction From Procedural Pain in Children
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|ClinicalTrials.gov Identifier: NCT03998995|
Recruitment Status : Completed
First Posted : June 26, 2019
Last Update Posted : June 26, 2019
This study explored the feasibility, acceptability and perceived the effectiveness of an Immersive Virtual Reality (IVR) 'game' in the rehabilitation of children with upper limb injuries. The objectives of the clinical trial were:
- To qualitatively assess the perceptions of child and parent regarding the acceptability of the game and equipment, and their perceptions of its effectiveness in reducing pain and discomfort and facilitating movement, compared to usual physical therapy experiences.
- To qualitatively assess physical therapy practitioners' perceptions of the effectiveness, usability, feasibility, and acceptability of VR in their clinical setting with this client group.
- IVR rehabilitation game as an intervention will be acceptable to child patients and their parents.
- IVR rehabilitation game experience will show less procedural pain, discomfort, and difficulties to movement, compared to usual physical therapy experiences.
- IVR rehabilitation game will demonstrate any perceived disadvantages as a therapeutic intervention, compared with usual rehabilitation care.
- IVR rehabilitation game will demonstrate usability in the clinical setting during the rehabilitation of a small sample of children with varying ULIs.
|Condition or disease||Intervention/treatment||Phase|
|Exostosis of Elbow Upper Extremity Fracture Burn; Arm Burn Scald||Device: Immersive Virtual Reality||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Device Feasibility|
|Official Title:||Virtual Reality Distraction From Procedural Pain in Children|
|Actual Study Start Date :||December 13, 2018|
|Actual Primary Completion Date :||April 30, 2019|
|Actual Study Completion Date :||April 30, 2019|
Experimental: IVR rehabilitation game intervention
Clinical trial patients' use the IVR rehabilitation game for two 15 minute sessions during one physical therapy session with their usual practitioner, with support from the physiotherapist and the game expert on the team.
Device: Immersive Virtual Reality
An Oculus Rift VR Headset and a set of Oculus Touch Controllers was used as interactivity device. Two scenarios of IVR rehabilitation game were offered to the patients: 1) Archery based on behind-the-neck overhead press, using a quiver on the user back to encourage bending their arm and firing the arrow to help with stretching exercises and 2) Climbing based on an overhead arm raise exercise.
Each child will took part in a single IVR trial during their rehabilitation care with the physiotherapist, supported by IP, the games expert/researcher. Timing of participation was approximately 15 minutes of trial with each scenario of game. A short interview was conducted with each child and their parent (together) after each trial, and a focus group was conducted with the clinical staff.
- Semi-structured interview with patients an family members [ Time Frame: 10 minutes ]The interviews try to reflect on their experience using IVR concerning technology acceptance, emotional affect, usability and future deployment. In particular the interviews focused on four main areas: (1) the attitudes towards the VR rehabilitation session (e.g., "What did you like/dislike about the VR session compared to the normal therapy session?"); (2) the perceived difficulty and pain levels (e.g., "Compared to normal therapy sessions what was the pain you felt?"); the system usability / acceptability (e.g., "What is your overall impression regarding the VR rehabilitation?"); and the future VR deployment (e.g., "In the future, could you see this kind of therapy as a form of rehabilitation?").
- Focus group with staff [ Time Frame: 45 minutes ]The interviews try to reflect on their experience using IVR concerning technology acceptance, emotional affect, usability and future deployment.
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): NCT03998995
|Sheffield Children's Hospital|
|Sheffield, South Yorkshire, England, United Kingdom, S10 2TH|