跳至主要内容
临床试验/NCT07264439
NCT07264439招募中不适用

Evaluation of the Effectiveness of Virtual Reality Headsets With Hypnotic Scenarios for Hygiene Care in Patients With Alzheimer's Disease or Related Disorders (ADRD) With Behavioral Disturbances

Centre Hospitalier Universitaire, Amiens1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2025年9月3日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
24
试验地点
1
主要终点
Effectiveness of VR headsets

研究概览

简要总结

A device combining a virtual reality (VR) headset with hypnotic scenarios may represent an effective tool to reduce anxiety and opposition during hygiene care in patients with neurocognitive disorders presenting with behavioral and psychological symptoms.

The primary objective of this project is to assess the feasibility and effectiveness of VR headsets with hypnotic scenarios compared with standard care in patients with ADRD presenting behavioral disturbances during hygiene care.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Crossover
主要目的
Other
盲法
None

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

  • •Residents of the St-Victor center (CHU Amiens-Picardie), including nursing home units, reinforced care units, and long-term care units;
  • •Patients diagnosed with ADRD presenting opposition or agitation during hygiene and toileting care;
  • •Affiliation to a social security scheme,
  • •Informed consent signed by the patient or legal representative.

排除标准

  • •Residents in terminal palliative care.

研究组 & 干预措施

controlled trial

Active Comparator

干预措施: standard cares (Other)

VR headset

Experimental

a virtual reality (VR) headset with hypnotic scenarios

干预措施: VR headset (Device)

结局指标

主要结局

Effectiveness of VR headsets

时间窗: up to 5 weeks

Effectiveness of VR headsets delivering hypnotic scenarios versus standard cares in older adults with ADRD and behavioral disturbances (opposition or agitation), with the aim of reducing apprehension, pain, anxiety, and resistance during hygiene and toileting care. Evaluation with EPADE sclae

次要结局

  • decrease number of patients with behavioral and psychological symptoms in VR headset group(up to 5 weeks)
  • reduced number of psychotropic drug per patient use in VR headset group(up to 5 weeks)
  • Number of patients with improve quality of life in VH headset group(up to 5 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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