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临床试验/NCT03998995
NCT03998995已完成不适用

Virtual Reality Distraction From Procedural Pain in Children

Sheffield Hallam University2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2018年12月13日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
10
试验地点
2
主要终点
Semi-structured interview with patients an family members

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Device Feasibility
盲法
None

入排标准

年龄范围
7 Years 至 16 Years(Child)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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

研究组 & 干预措施

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.

干预措施: Immersive Virtual Reality (Device)

结局指标

主要结局

Semi-structured interview with patients an family members

时间窗: 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

时间窗: 45 minutes

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

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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