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临床试验/NCT06612892
NCT06612892已完成不适用

Immersive Versus Passive Virtual Reality on Upper Limb Pain and Range of Motion in Pediatric Burn

Cairo University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年3月10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
60
试验地点
1
主要终点
assessing the pain intensity using Colored Analog Scale (CAS)

研究概览

简要总结

The purpose of the present study was to declare the difference between using immersive virtual reality vs passive virtual reality on pain management and improvement of ROM post physiotherapy exercise and mobilization sessions in pediatric burn patients.

详细描述

Burn injuries are devastating and cause long-term damage to health. Thermal injuries, caused by hot liquids, solids, or fire, account for the majority of these injuries. Around 11 million burn cases occur annually worldwide. Rehabilitation aims to improve joint range od motion and control pain. Nonpharmocologic strategies like hypnosis and VR systems have shown promise in pain control. Multidisciplinary interventions from psychologists, physiotherapists, and pain management specialists can contribute to patient recovery. VR offers a holistic care device for pediatric burn patients.

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
Single (Participant)

入排标准

年龄范围
7 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Sixty patients have 2nd degree thermal burn injury, from both genders their ages will be ranged from 7 - 17 years old.
  • They will be diagnosed by their physicians with 2nd degree thermal burn injury affecting upper limbs and referred for physical therapy management .
  • TBSA calculated up to 9 for one upper limb.
  • The patients will be in the acute stage post burn injury; the duration of burn will be 3 weeks post injury.
  • Medically and psychologically stable patients

排除标准

  • The potential participants will be excluded if they meet one of the following criteria:
  • Cardiac diseases.
  • Exposed tendons.
  • Patients who suffer from skin diseases, diabetes, varicose veins, and peripheral vascular diseases.
  • Patients with life threatening disorders as renal failure, myocardial infarction or other similar diseases.
  • Patients with facial burn.
  • Patients will have an inability to tolerate visual stimulation (e.g., susceptibility to migraines aggravated by light) or inability to tolerate the head mounted display (e.g., sensitivity to touch around the face and head).
  • Patients with visual or auditory disorders.
  • Patients with unstable fractures.
  • Central Nervous System (CNS) problems.
  • Patients with medical red flags as severe psychiatric disorder or cognitive deficits .
  • Medically unstable and uncooperative patients.

结局指标

主要结局

assessing the pain intensity using Colored Analog Scale (CAS)

时间窗: at baseline and after 6 weeks

The Colored Analog Scale (CAS) is a thermometer-like tool that gradually darkens red as you progress, allowing children to indicate their pain levels with markers on the scale's back.

assessing the range of motion using digital goniometer

时间窗: at baseline and after 6 weeks

The physical therapist will have to measure ROM before and after the intervention to monitor the improvement ,as the study focus on upper limb range of motion , following joints movement will be measured : shoulder flexion and abduction , elbow flexion and extension , wrist flexion and extension , forearm supination and pronation)

次要结局

未报告次要终点

研究者

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

Haytham Mostafa

principal investigator

Cairo University

研究点 (1)

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