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Virtual Reality Distraction From Procedural Pain in Children

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03998995
Recruitment Status : Completed
First Posted : June 26, 2019
Last Update Posted : June 26, 2019
Sponsor:
Collaborator:
Medical Research Council
Information provided by (Responsible Party):
Sheffield Hallam University

Brief Summary:

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.

Hypothesis:

  1. IVR rehabilitation game as an intervention will be acceptable to child patients and their parents.
  2. IVR rehabilitation game experience will show less procedural pain, discomfort, and difficulties to movement, compared to usual physical therapy experiences.
  3. IVR rehabilitation game will demonstrate any perceived disadvantages as a therapeutic intervention, compared with usual rehabilitation care.
  4. 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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: N/A
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arm Intervention/treatment
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.





Primary Outcome Measures :
  1. 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?").

  2. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   7 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Aged 7-16
  • Upper limb or hand injuries, for which they are receiving rehabilitative care
  • Able to speak and understand English

Exclusion Criteria:

  • Injuries to the face or head that could hinder the correct positioning of the headset or pose an infection risk
  • A learning impairment that could hinder the understanding of the task
  • A history of severe motion sickness or vertigo.
  • Mental health problems, such as anxiety.

Eligibility for parents:

  • Having a child taking part in the study
  • Being available on the day of treatment for interview
  • Able to speak and understand English.

Eligibility for staff:

  • Having a patient trialing VR during physiotherapy during which they were present as practitioner
  • Being able to speak and understand English
  • Being available on the day of the focus group

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): NCT03998995


Locations
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United Kingdom
Sheffield Children's Hospital
Sheffield, South Yorkshire, England, United Kingdom, S10 2TH
Sponsors and Collaborators
Sheffield Hallam University
Medical Research Council
Additional Information:
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Responsible Party: Sheffield Hallam University
ClinicalTrials.gov Identifier: NCT03998995    
Other Study ID Numbers: J767 VR Children's Rehab
SCH2178 ( Other Identifier: Sheffield Children's Hospital )
First Posted: June 26, 2019    Key Record Dates
Last Update Posted: June 26, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sheffield Hallam University:
Immersive Virtual Reality (IVR)
Patient-Centred Design
Upper Limb Injury
Children Rehabilitation
Additional relevant MeSH terms:
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Exostoses
Pain, Procedural
Burns
Wounds and Injuries
Pain
Neurologic Manifestations
Hyperostosis
Bone Diseases
Musculoskeletal Diseases