Non-pharmacological Pain Care Using Virtual Reality Therapy or Music Therapy During Complex Wound Care in Adults
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 72
- 试验地点
- 2
- 主要终点
- The primary outcome is the change in pain score before and after the first wound care, measured with the Visual Analogue Scale (VAS).
研究概览
简要总结
The main objective of this study is to evaluate the effect on pain and both Virtual Reality and Music Therapy as add-on therapy during wound car in adults.
详细描述
After inclusion and completion of the informed consent form, patients are randomly allocated to the intervention group or control group in a 1:1:1 ratio. Randomization will not be blinded since both the provider and patient know if the patient will be wearing the VR system or headphone with audio during wound care or not wearing the VR system or headphone with audio.
Patients are randomly assigned to one of three groups:
Group 1 - Intervention group 1, Virtual Reality Therapy Group 2 - Intervention group 2, Music Therapy Group 3 - Control group, care as usual
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Randomization will not be blinded since both the provider and patient know if the patient will be wearing the VR system or headphone with audio during wound care or not wearing the VR system or headphone with audio.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals aged 18 or older who have wounds receiving wound care
- •Individuals who will undergo minimum of 1 to a maximum of 3 sequential complex wound care procedures before discharge
- •At least 1 prior painful wound care procedure, where they have indicated a VAS ≥ 4, or patients reporting a VAS ≥ 4 before initiating the wound care procedure.
排除标准
- •Individuals not being able to understand Dutch language at primary school level
- •Individuals not being able to read or write Dutch
- •Individuals diagnosed with dementia and/or cognitive impairment
- •Individuals diagnosed with epilepsy
- •Individuals diagnosed with migraine
- •Individuals with severe dizziness and/or nausea
- •Individuals with a known history of claustrophobia
- •Individuals who are unable to sign informed consent owing to mental disorder or formally stated to be incompetent to decide
- •Individuals who have no feeling in the wound care area
- •Individuals with physical (and/or cognitive) disabilities on the face, eye, ear, nose and neck that prevent the use of the VR headgear and/or headphones
结局指标
主要结局
The primary outcome is the change in pain score before and after the first wound care, measured with the Visual Analogue Scale (VAS).
时间窗: Baseline, during the procedure, immediately after procedure
The VAS is a horizontal scale from 0 to 10, with 0 indicating ''no pain'' and 10 indicating ''worst pain possible''.
次要结局
- Mean VAS change of all wound care procedures included in the study(Baseline, during the procedure, immediately after procedure)
- Change from baseline in level of anxiety at 10 minutes after procedure(Baseline, 10 minutes after procedure)
- Patient satisfaction(Through study completion, an average of 1 week)
- Provider satisfaction(Through study completion, an average of 1 year)
- Change from baseline systolic blood pressure and diastolic blood pressure at 5 minutes after procedure(Baseline, 5 minutes after procedure)
- Change from baseline blood oxygen level at 5 minutes after procedure(Baseline, 5 minutes after procedure)
- Change of pulse rate during procedure(During procedure)
- Change of respiratory rate during procedure(During procedure)
- Change of systolic blood pressure and diastolic blood pressure during procedure(During procedure)
- Change of blood oxygen level during procedure(During procedure)
- Change from baseline pulse rate at 5 minutes after procedure(Baseline, 5 minutes after procedure)
- Change from baseline respiratory rate at 5 minutes after procedure(Baseline, 5 minutes after procedure)
研究者
Marlies P. Schijven
Professor doctor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)