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

NCT07264439 | Recruiting

• 1 other identifier: PI2025_843_0010
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Keywords

Effectiveness; virtual reality; hypnotic scenarios; hygiene care; Alzheimer's disease and related disorders (ADRD); behavioral disturbances

Outcome Measures

Primary Outcomes (1)

• Effectiveness of VR headsets

  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

  up to 5 weeks

Secondary Outcomes (3)

• 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

Study Arms (2)

controlled trial

ACTIVE COMPARATOR

Other: standard cares

VR headset

EXPERIMENTAL

a virtual reality (VR) headset with hypnotic scenarios

Device: VR headset

Interventions

VR headset 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.

VR headset

standard cares OTHER

standard cares

controlled trial

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Residents in terminal palliative care.

Sponsors & Collaborators

• Centre Hospitalier Universitaire, Amiens: lead

Study Sites (1)

Amiens University Hospital

Amiens, 80054, France

RECRUITING

MeSH Terms

Conditions

Alzheimer Disease; Mental Disorders

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders

Central Study Contacts

Frédéric Bloch, MD

CONTACT

33+3 22 08 80 51; Bloch.frederic@chu-amiens.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2025
• First Posted: December 4, 2025
• Study Start: September 3, 2025
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: December 4, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)