跳至主要内容
临床试验/NCT02929771
NCT02929771已完成不适用

Using Virtual Reality to Reduce Procedural Pain in Children With Cancer: A Pilot Randomized Controlled Trial

The Hospital for Sick Children2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2017年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
2
主要终点
Accural Rates/Retention Rates

研究概览

简要总结

This study will assess the impact of virtual reality (VR) in decreasing procedural pain related to subcutaneous port (SCP) access in children with cancer. The study is a pilot-randomized controlled trial (RCT) using a cross-over design that will provide us with detailed information on the feasibility of implementing our trial protocol in a future multi-center RCT as well as preliminary estimate of VR treatment effect on children with cancer undergoing SCP access, including child and parent factors potentially associated with VR distraction treatment efficacy.

详细描述

The study is a repeated-measures cross-over pilot RCT to examine the feasibility of the trial protocol for a study into the effectiveness of immersive VR in minimizing procedural pain and distress in children with cancer. The research objectives are to: (1) pilot implementing immersive virtual reality (VR) for effectiveness testing in a future RCT (measured as implementation outcomes); (2) determine treatment effect sizes (measured as preliminary effectiveness outcomes), between VR, programmed to distract children during an SCP needle insertion, and an active control intervention (i.e., watching a video with headphones); and (3) assess impact of child and parent factors potentially associated with VR treatment effectiveness. Both the intervention and control groups will receive standard medical care (e.g., topical anesthetics). A convenience sample of 40 children and adolescents with cancer (20 participants per treatment arm; 10 boys and 10 girls per treatment arm) will be recruited. In addition, each child will act as their own control. A washout period of 1 month will be used to control for any carry-over effect between conditions. In addition to usual care, children in the experimental condition will wear the VR headset plus headphones. In the control condition, children will watch a video (i.e., an age-appropriate video selected by an oncology-affiliated child life specialist) on an iPad, while wearing the same headphones as in the experimental condition. Implementation outcomes include accrual and retention rates, acceptability and technical difficulties. Effectiveness outcomes include child pain, distress, and fear, as well as parent distress.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
8 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Child and parent able to speak and understand English
  • actively undergoing cancer treatment
  • being less than 1 year from initial diagnosis
  • requiring at least 2 SCP needle insertions for cancer treatment over the following 8 weeks

排除标准

  • visual, auditory or cognitive impairments precluding interaction with the intervention or control equipment
  • patients with major co-morbid medical or psychiatric conditions (including needle-phobia_ as per their healthcare provider or parent
  • end of life patients
  • patients with a MRSA infection or symptoms of respiratory or gastrointestinal infection as per any member of their healthcare team which could contaminate the intervention or control equipment
  • participation in usability study

结局指标

主要结局

Accural Rates/Retention Rates

时间窗: 6 months

Using a recruitment log to measure eligible children per recruitment day, reasons for ineligibility, reasons for non-participation and reasons for study attrition.

Acceptability

时间窗: 6 months

Measured using the VR Distraction Satisfaction Questionnaire completed by children and nurses and will collect data on acceptability, perceived utility of pain reducing procedures, and recommendations for changes related to the needle insertion experience.

Outcome measure feasibility

时间窗: 6 months

Will be measured as the percentage of completed outcome measures at baseline and study completion and will be recorded on the VR Distraction Activity Log

Technical Difficulties/Practical Difficulties

时间窗: 6 months

Record data related to technical/practical difficulties associated with the VR intervention, RA observed difficulties in implementing the trial protocol in the clinic and time to complete SCP access.

次要结局

  • Parent Distress(6 months)
  • Pain Intensity(6 months)
  • Child Distress(6 months)
  • Child Fear(6 months)
  • Child Pain Catastrophizing(6 months)
  • Parent Pain Catastrophizing(6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jennifer Stinson

Clinician Scientist, Clinical Nurse Specialist/NP, PhD

The Hospital for Sick Children

研究点 (2)

Loading locations...

相似试验