NCT00993889已完成不适用
Virtual Reality Analgesia During Pediatric Physical Therapy
National Institute of General Medical Sciences (NIGMS)2 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2009年5月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Pain and anxiety
研究概览
简要总结
We would like to determine whether Virtual Reality (VR) analgesia continues to be effective for reducing pain when administered for a clinically relevant treatment duration over multiple, repeated exposures (i.e., up to ten sessions of physical therapy per patient).
详细描述
This study is done in a hospital for inpatients pediatrics. By randomization some subjects will immersive Virtual Reality (VR) during a painful procedure on daily basis up to 10 days to see whether this will reduce the pain and anxiety.
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 (Care Provider)
入排标准
- 年龄范围
- 5 Years 至 20 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age greater than or equal to 8 years up to 20 yrs old
- •Compliant and able to complete subject evaluation
- •A minimum of 3 days of physical therapy, one physical therapy session per day
- •No history of psychiatric (DSM-IV-R Axis I) or developmental disorder that would interfere with decisional capacity
- •Not demonstrating delirium, psychosis, or any form of Organic Brain Disorder that would interfere with decisional capacity
- •Able to communicate verbally
- •Able to take oral medications
- •English-speaking
排除标准
- •- Age less than 8 years, or greater than 20 years.
- •Not capable of indicating pain intensity
- •Not capable of filling out study measures
- •Hospitalization of fewer than 3 days
- •Evidence of traumatic brain injury
- •History of psychiatric (DSM-IV-R Axis I) disorder as evidenced in the admitting RN and MD admission notes, if interfering with decisional capacity
- •Demonstrating delirium, psychosis or any form of Organic Brain Disorder and associated memory problems that would interfere with decisional capacity
- •Unable to communicate verbally
- •Unable to take oral medications
- •History of sig. cardiac, endocrine, neurologic, metabolic, respiratory, gastrointestinal or genitourinary impairment that would interfere with treatment or decisional capacity
- •Receiving prophylaxis for alcohol or drug withdrawal
- •Developmental disability that would interfere with decisional capacity
- •Face/head/neck injuries preventing helmet use
- •Non-English-speaking
- •Extreme susceptibility to motion sickness
- •Seizure history
结局指标
主要结局
Pain and anxiety
时间窗: pre and post procedure
次要结局
未报告次要终点
研究者
David R. Patterson
PhD.ABPP. Professor
National Institute of General Medical Sciences (NIGMS)
研究点 (2)
Loading locations...
相似试验
Unknown
不适用
The Feasibility and Clinical Utility of the Use of Virtual Reality for the Management of Pediatric Dental AnxietyChildren, OnlyDental AnxietyBehaviorNCT06380283McGill University Health Centre/Research Institute of the McGill University Health Centre128
已完成
不适用
Efficacy of Virtual Reality in Pain Reduction in Orthopedic Pediatric PatientsOrthopedic DisorderFractures, BoneNCT04901793Ochsner Health System95
终止
不适用
Assessing the Efficacy of Virtual Reality Analgesia (VRA) in Pediatric Patients for Pain ControlPainNCT03480724Montefiore Medical Center55
已完成
不适用
Virtual Reality During Intrathecal Pump Refills in ChildrenCerebral PalsyNCT04737668Moens Maarten6
已完成
不适用
Impact of Virtual Reality on Peri-interventional Pain, Anxiety and Distress in a Pediatric Oncology Outpatient ClinicPediatric CancerProcedural AnxietyProcedural PainNCT06235723Hannover Medical School38