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Recruiting NCT07264439

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

No phase Interventional Effectiveness Virtual Reality Hypnotic Scenarios Hygiene Care

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: VR headset, standard cares.
Who it may be relevant to
Registry conditions: Effectiveness, Virtual Reality, Hypnotic Scenarios, Hygiene Care. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • Device VR headset
    VR headset enabling the management of hypnotic scenarios. The headset will project immersive 3D images and deliver a hypnotic narrative, thus combining VR and hypnosis-based techniques. This intervention will be applied during hygiene and toileting care and compared to standard behavioral management traditionally used in the structures.
  • Other standard cares
    standard cares

Primary outcome measures

  • Effectiveness of VR headsets [Time frame: up to 5 weeks]
Secondary outcome measures (3)
  • decrease number of patients with behavioral and psychological symptoms in VR headset group [Time frame: up to 5 weeks]
  • reduced number of psychotropic drug per patient use in VR headset group [Time frame: up to 5 weeks]
  • Number of patients with improve quality of life in VH headset group [Time frame: up to 5 weeks]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • Residents in terminal palliative care.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Crossover
Masking
Open label
Primary purpose
Other

Study locations

France · 1 center
  • Amiens University Hospital — Amiens

Identifiers

NCT: NCT07264439 · PI2025_843_0010

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗