Virtual Reality Distraction From Procedural Pain in Children

NCT03998995 | Completed

• 2 other identifiers: J767 VR Children's RehabSCH2178
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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:
• 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.

Conditions

Exostosis of Elbow; Upper Extremity Fracture; Burn; Arm; Burn Scald

Keywords

Immersive Virtual Reality (IVR); Patient-Centred Design; Upper Limb Injury; Children Rehabilitation

Outcome Measures

Primary Outcomes (2)

• Semi-structured interview with patients an family members

  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?").

  10 minutes

• Focus group with staff

  The interviews try to reflect on their experience using IVR concerning technology acceptance, emotional affect, usability and future deployment.

  45 minutes

Study Arms (1)

IVR rehabilitation game intervention

EXPERIMENTAL

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

Interventions

Immersive Virtual Reality DEVICE

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.

IVR rehabilitation game intervention

Eligibility Criteria

• Age: 7 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sheffield Hallam University: lead
• Medical Research Council: collaborator

Study Sites (1)

Sheffield Children's Hospital

Sheffield, South Yorkshire, England, S10 2TH, United Kingdom

Location

Related Publications (1)

• Phelan I, Furness PJ, Matsangidou M, Carrion-Plaza A, Dunn H, Dimitri P, Lindley SA. Playing your pain away: designing a virtual reality physical therapy for children with upper limb motor impairment. Virtual Real. 2023;27(1):173-185. doi: 10.1007/s10055-021-00522-5. Epub 2021 Jun 9.

  PMID: 36915630 DERIVED

Related Links

• IVR Children's Rehabilitation study: A presentation in the BBC Click program.

MeSH Terms

Conditions

Burns; Arm Injuries

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2019
• First Posted: June 26, 2019
• Study Start: December 13, 2018
• Primary Completion: April 30, 2019
• Study Completion: April 30, 2019
• Last Updated: June 26, 2019

Record last verified: 2019-06

Locations

GB (1)