NCT06985732

Brief Summary

The objective of this clinical trial is to evaluate the effect of using virtual reality on the well-being of elderly patients hospitalized in SMR for 3 weeks. The study also allows to evaluate the effect of VR on apathy, and the autonomy of patients hospitalized in the SMR department for 3 weeks.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
4mo left

Started Sep 2025

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress68%
Sep 2025Sep 2026

First Submitted

Initial submission to the registry

May 14, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 22, 2025

Completed
3 months until next milestone

Study Start

First participant enrolled

September 1, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2026

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Expected
Last Updated

May 28, 2025

Status Verified

May 1, 2025

Enrollment Period

6 months

First QC Date

May 14, 2025

Last Update Submit

May 22, 2025

Conditions

Virtual Reality

Outcome Measures

Primary Outcomes (1)

  • WHO-5

    measure well-being. The score is between 0-100 a high score means better wellness

    4 times throughout of study at baseline and after each VR session

Study Arms (2)

VR group

EXPERIMENTAL
Other: Virtual Reality

contrrol arm

NO INTERVENTION

Interventions

Virtual RealityOTHER

Use of virtual reality to elicit positive emotions and improve the well-being of elderly patients hospitalized in SMR

VR group

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • People hospitalized in the SMR unit at La Porte Verte Hospital for a minimum of 3 weeks,
  • People with preserved or slightly impaired cognitive status with an MMSE ≥ 20,
  • People who have been informed and have signed written informed consent

You may not qualify if:

  • People under guardianship or curatorship,
  • People with difficulty understanding the VR study and materials,
  • People with vision problems that impact the use of VR,
  • People with hearing problems that impact the use of VR,
  • People with epilepsy,
  • People at risk of nausea and dizziness when using the VR headset,
  • People who cannot tolerate the VR headset,
  • Not affiliated with a social security scheme.
  • People receiving care with reflexology and relaxation massage

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

Baptiste ISABET

CONTACT

0634227138Baptiste.ISABET@lpv.univi.fr

Fatima Zohra IZEDAREN

CONTACT

Fatima-Zohra.Izedaren@lpv.univi.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 14, 2025

First Posted

May 22, 2025

Study Start

September 1, 2025

Primary Completion

March 1, 2026

Study Completion (Estimated)

September 1, 2026

Last Updated

May 28, 2025

Record last verified: 2025-05