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

NCT ID: NCT07264439

Last Updated: 2025-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-03

Study Completion Date

2027-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Effectiveness Virtual Reality Hypnotic Scenarios Hygiene Care Alzheimer's Disease and Related Disorders (ADRD) Behavioral Disturbances

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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controlled trial

Group Type ACTIVE_COMPARATOR

standard cares

Intervention Type OTHER

standard cares

VR headset

a virtual reality (VR) headset with hypnotic scenarios

Group Type EXPERIMENTAL

VR headset

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

standard cares

standard cares

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire, Amiens

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Amiens University Hospital

Amiens, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Frédéric Bloch, MD

Role: CONTACT

33+3 22 08 80 51

Facility Contacts

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Frédéric BLOCH, MD

Role: primary

03 22 45 57 20

Other Identifiers

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PI2025_843_0010

Identifier Type: -

Identifier Source: org_study_id

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