Virtual Reality Distraction From Procedural Pain in Children
Condition: Exostosis of Elbow; Upper Extremity Fracture; Burn; Arm; Burn Scald
MeSH terms: Exostoses; Pain, Procedural; Burns
Study type: Interventional

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.
    

Detailed description: 
      Children with upper limb and hand injuries often have to undergo repetitive therapeutic
      exercises to regain or maximise function and movement which can be painful, uncomfortable and
      tedious, reducing compliance and limiting the movement and function achieved. There is a
      growing body of literature demonstrating the effectiveness of VR in reducing pain (e.g. in
      burns). Its effectiveness in rehabilitation, especially in children, is a promising but
      under-researched area. This study was focus on an under-researched target group in relation
      to IVR interventions, children undergoing physical therapies to enhance or optimise the upper
      limb and hand movement.

      PARTICIPANT RECRUITMENT AND INFORMED CONSENT 10 children were recruited, plus one parent from
      each, and members of the clinical team of physiotherapists involved in their care. If
      considered suitable for the research, participants were introduced to the study and recruited
      via clinical staff responsible for their care. Staff was asked to provide information sheets
      to those who show interest in participation, including separate sheets for both child and
      parent.

      If, having discussed the study with their child and other family members, parents were happy
      for their child to participate, and the child also wishes to participate, parents were asked
      to let a member of their clinical team know and arrangements were made for the date and time
      when the research will be take place.

      Focus group: clinical staff involved in physical therapy for children where the VR
      intervention has been trialed was invited verbally, by letter or email to participate in a
      focus group after the trial is complete, and provided with an information sheet.

      Having expressed an interest in hearing more about the study, based on a simple verbal
      explanation provided by staff, potential parents and children were provided with full,
      printed information (age-appropriate for children) about the study to read and consider in
      their own time. The information included a statement that participation is not obligatory and
      reassurance that refusal to participate will not affect their care, also explain that having
      decided to participate, the parent and child will be free to change their mind before, during
      or immediately after the study (prior to data analysis), without giving a reason. Advice was
      provided regarding how to withdraw their consent. Details regarding confidentiality,
      anonymity, data access, storage, and retention also were provided. It was suggested that the
      person retain the Information sheet for future reference and in order to make contact with
      the research team. Parents/children who, having read the information sheet and discussed the
      study together, wish to participate was asked to let the clinical staff know. Clinical staff
      contacted IP and made arrangements for him to visit the Unit on one of the child's
      appointment dates, to conduct the research. Shortly prior to using the VR for the trial on
      the day and before written consent was taken, the child was offered a 5-10 minute exposure to
      activities in the VR game (e.g. archery activity, rock climbing activity), to familiarise
      themselves, check there are no problems, and avoid unnecessary distractions and confusion
      during the procedure itself. If there were any problems or the child becomes unhappy about
      participation at this stage, they were reassured that they don't have to participate if they
      prefer not to and can also withdraw at any point during trial themselves if they wish. They
      were reminded verbally at this stage that deciding the study is not for them would have no
      consequences whatever for their future treatment.

      If the child and their parent, having read the Information Sheet, expressed a wish to
      participate, tried out the equipment, and asked any questions they have, wish to go ahead,
      the parent was asked to sign a consent form and the child was asked to complete an assent
      form. This was done in the presence of a clinician on the research team, ahead of the
      intervention being implemented. Copies was be retained by the team, given to participants,
      with one copy kept in the child's medical notes.

      DATA COLLECTION AND ANALYSIS A short interview was conducted with each child and their parent
      (together) after each trial and was audio recorded. These interviews took place in a quiet,
      private location near to where the physiotherapy and trial have taken place.

      Focus groups with staff took place after all children's trials, in a quiet and private
      environment and at a time convenient for participants. Interviews and focus groups were
      guided by pre-written schedules and audio-recorded.

      Thematic analysis was applied to all the resulting qualitative data, resulting from
      interviews with each child and parent, and focus group with therapeutic staff. This involved
      a process of careful reading, coding and comparison in order to identify important patterns
      in the data, focused on answering the aims of the study. Themes were generated based upon the
      analysis process, which were discussed and refined within the research team.

      DATA HANDLING AND RECORD KEEPING On consenting to participate, participants were given a code
      (e.g. 01C, 01P for child01, parent01), by which they were identified for the duration of the
      study and in reports. A file linking participant identity to codes was created, password, and
      stored securely within a study file on a SHU password protected computer, as well consent
      forms. The lead investigator, IP, collect all data. He was audio record interviews and the
      focus group. Password protected digital recorders was used during interviews/focus groups to
      ensure data safety whilst on the ward and in transit back to the office. Recordings were
      saved as audio files on University-based password protected computers, then deleted. Audio
      files were used to create transcripts in the form of word documents, and both were securely
      stored in password protected computer files held by research team members. No one from
      outside the research team will have access to any information by which participant identity
      and data can be linked. The SHU and MRC Guidelines for research with human participants were
      followed in all aspects of the research, including data confidentiality. No one from the
      research team (who is not also a member of participants' clinical team) will require access
      to participants' medical records. Clinicians in the research team may make use of medical
      records - and their knowledge of their patients - in deciding whether to introduce the
      parent/child to the research study.

      Consent forms are kept in locked cabinets in the locked office of the SHU-based project
      manager, SL. The cabinets themselves are kept locked (by key) at all times and only the
      key-holder will be able to access office and cupboards. Data collected for the study will be
      treated with the utmost care, retained within the research team, password
      protected/encrypted, and no one outside the team will have access. Personal information is
      securely stored within the SHU-based password protected computer files and separately from
      anonymised raw data. Files are password protected and encrypted for transfer.

      Anonymised transcriptions made from the audio files and these are also saved as password
      protected files, identified by participant code. In reports, quotes from individuals will be
      only identified by participant code.

      Throughout, data are stored securely and a study file maintained by SL. If the team is
      disbanded prior to this time, data will be stored at Sheffield Hallam University's research
      archive, SHURDA. Data will be collected and retained in accordance with the Data Protection
      Act 1998. All source documents will be retained for a period of 10 years following the end of
      the trial.

      SAFETY ASSESSMENTS The Oculus Rift Virtual Reality headset was used with a laptop computer
      and all equipment was safety tested by the university before it used on participants.
      Appropriate health and safety measures were taken throughout the sessions, with each session
      limited to 15 minutes, with breaks in-between. Playing virtual reality games can sometimes
      cause disorientation, dizziness or nausea in some people, for example, those with severe
      motion sickness. However, in the most recent versions of this technology, and in our own
      recent trials of similar games, adverse reactions have been rare. Virtual rock climbing can
      also create anxiety in some children, especially if they suffer from vertigo. To check they
      were happy with the experience of VR before their sessions start, children were provided with
      a short 'test' session in the headset before parent and child agree to continue. Once the
      trial is underway, we asked the participating children to let us know straight away if they
      begin to feel uncomfortable or unwell.

      The study was monitored and audited in accordance with the Monitoring Standard Operating
      Procedures of the Directorate of Research & Innovation at Sheffield Children's NHS Foundation
      Trust. All study related documents will be made available on request for monitoring and
      audits by the Sponsor, the Health Research Authority and the relevant Research Ethics
      Committee.

      ETHICAL CONSIDERATIONS The study has been reviewed and approved by Sheffield Hallam
      University Research Ethics Committee, NHS Research Ethics Committee, and the Research and
      Development Dept. at Sheffield Children's Hospitals. The study was conducted in compliance
      with a Research Ethics Committee favourable opinion, Health Research Authority approval and
      Confirmation of Capacity & Capability at all participating sites.

      The study was conducted in accordance with the International Conference for Harmonisation of
      Good Clinical Practice (ICH GCP), and the Research Governance Framework for Health and Social
      Care (2nd Edition).
    

Intervention name(s): Immersive Virtual Reality
Intervention type(s): Device
Intervention description(s): 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.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Device Feasibility
Keywords: Immersive Virtual Reality (IVR); Patient-Centred Design; Upper Limb Injury; Children Rehabilitation