Virtual Reality During Procedures in Pediatric Patients

Johns Hopkins University2 个研究点分布在 1 个国家目标入组 64 人开始时间: 2019年7月5日最近更新: 2020年8月6日

适应症

试验速览

阶段: 不适用
状态: 终止
发起方: Johns Hopkins University
入组人数: 64
试验地点: 2
主要终点: Change in Adult's Own Anxiety During the Procedure

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This stratified, randomized, controlled trial compared coping and distress between child life supported virtual reality engagement and child life support during painful procedures in the pediatric emergency department.

详细描述

Pediatric emergency rooms and hospitals are anxiety provoking and often painful places for pediatric patients and families. Children of all ages present to the Johns Hopkins emergency room and are admitted to the hospital for a wide range of medical conditions, many of which require medical interventions. Many of these interventions are the source of anxiety and pain, including burn debridement or dressing changes, laceration repair, or intravenous (IV) line placement. The standard of care to reduce pain and improve coping during pediatric procedures ranges from no intervention to support from child life specialists.

As an adjunct to the existing methods of promoting comfort during painful procedures, non-invasive virtual reality (VR) therapy is showing promise as a means of distraction and coping with various medical procedures. The user is transported into a relaxing/distracting VR environment that diverts user's attention away from pain and anxiety. VR has demonstrated efficacy in the reduction of pain and anxiety experienced by individuals undergoing anxiety and pain inducing procedures.While there is early data from small or narrow populations that show some improvement in pain and anxiety with VR use during pediatric procedures, some studies show no improvement. No studies to date have used objective outcome measures of coping, which may be more clinically meaningful.

The investigators propose to fill this gap in the literature with a randomized, controlled, un-blinded study of coping and distress between virtual reality engagement and child life support in pediatric patients undergoing painful medical procedures.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Treatment
盲法: None

入排标准

年龄范围: 7 Years 至 26 Years（Child, Adult）
性别: All
接受健康志愿者: 是

入选标准

•Pediatric patients requiring painful or anxiety inducing procedures:
•Burn debridement
•Burn dressing change
•Lactation repair
•Intravenous (IV) line placement or phlebotomy (blood draw)
•Abscess incision and drainage
•Fracture reduction and/or cast placement
•Implanted central venous port placement accessing
•Skin biopsies
•Subjects ages 7 to 26 years of age (age 26 is the upper limit treated at JHCC) Ages were chosen based on that previously published in the literature on pediatric patients with VR.

排除标准

•Patients with a known history of a seizure disorder.
•Patients with an active infection, burn, or trauma that interferes with the mask placement, and may include involvement of the periorbital skin, eyes, nasal bridge, external ear, and/or scalp or hair.
•Patients with Blindness.
•Developmental delay significant enough to interfere with the subject's ability to participate in the session, including autism spectrum disorders.
•Patients with active psychosis or exhibit signs of active intoxication.
•Known history of severe motion sickness
•Medical urgency (at the medical providers' discretion)
•Non-verbal children
•Children or parents/legal guardians who are non-English speakers