Comparison of the Benefits of a Personalized Intervention (Virtual Environment and Device) Compared to Usual Care

NCT05759026 | Completed

• 1 other identifier: 22-PP-23
• Study Type: interventional
• Target: 87
• Locations: 1 country
• Sites: 1

Brief Summary

The medical environment can create stressful and anxiety-provoking situations for patients, especially during painful procedures, particularly in older adults. These stressful environments have a deleterious effect on the quality of care, even putting the patient at risk and the health care team at risk. The search for a solution is therefore imperative. The evolution of new technologies, such as virtual reality (VR), seems to be an answer to this challenge. Through a multidisciplinary research (psychology and medicine), this project proposes to study the factors allowing to improve the management of older adults during their care using VR. More precisely, different individual factors (age, cognitive level, individual preferences...) and different virtual reality universes (relaxation, landscapes...) on different supports (headsets and touch tablet) will be studied in order to understand the roles of these factors on pain and anxiety management during care procedures. This trial is an interventional, randomized, open-label, single-center study of 100 people over 60 years old. The aim of this project is to improve the quality of life of hospitalized patients but also of caregivers in their work environment. It is expected a significant reduction of pain and anxiety during the intervention with a personalized equipment and environment, compared to usual care conditions. The hypotheisis is also that these interventions, aimed at reducing pain and anxiety in patients, will have beneficial effects on the quality of work life of the caregivers performing the care.

Conditions

Elderly

Outcome Measures

Primary Outcomes (2)

• Visual Analog Scale (VAS) - Pain and Anxiety

  The Visual Analog Scale (VAS) is a self-report scale that allows the patient to evaluate their feelings using a slider that goes from 0 to 10 points (worse score is 10)

  immediatly before care

• Visual Analog Scale (VAS) - Pain and Anxiety

  The Visual Analog Scale (VAS) is a self-report scale that allows the patient to evaluate their feelings using a slider that goes from 0 to 10 points (worse score is 10)

  immediatly after care

Secondary Outcomes (9)

• HAD scale (Hospital Anxiety Depression scale)

  immediately beafore care

• HAD scale (Hospital Anxiety Depression scale)

  immediately after care

• Algo Plus Scale

  during care

• Heart rate measurment with Oximeter

  2 minutes before the medicale procedure

• Heart rate measurment with Oximeter

  2 minutes after the medicale procedure

Study Arms (3)

control condition

EXPERIMENTAL

The patient will be randomized so that the kind of intervention will be determined in a random way.

Other: Accompaing cares

with VR

EXPERIMENTAL

The patient will be randomized so that the kind of intervention will be determined in a random way.

Other: Accompaing cares

with VR personalised

EXPERIMENTAL

The patient will be randomized so that the kind of intervention will be determined in a random way.

Other: Accompaing cares

Interventions

Accompaing cares OTHER

After signing the consent form, the patient will be randomised. The ones randomised in VR groups will choose their preferred environment (e.g. landscapes, animals...). The participant will be managed during 1 care (one care in control condition (no material used), care with the VR headset, one care with the VR set and the prefered environnent of the patient) for an average of 30 minutes (including the completion of the scales and questionnaires).

control condition; with VR; with VR personalised

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men or Women
• Over 60 years old
• Subject affiliated to the Social Security
• Patient receiving 4 identical cares as part of routine care

You may not qualify if:

• Presence of visual and auditory disorders contraindicating the use of a VR headset;
• Unstabilized epilepsy;
• Acute psychiatric disorders
• Vulnerable population

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (1)

CHU de Nice - Hopital de Cimiez

Nice, 06000, France

Location

Related Publications (1)

• Corbel C, Le Cerf F, Capriz F, Vaillant-Ciszewicz AJ, Breaud J, Guerin O, Corveleyn X. The management of pain and anxiety using virtual reality during the care of elderly hospitalized patients: Study protocol for a randomized controlled trial. Contemp Clin Trials. 2025 Aug;155:107990. doi: 10.1016/j.cct.2025.107990. Epub 2025 Jun 23.

  PMID: 40562303 DERIVED

Study Officials

• Olivier GUERIN

  Centre Hospitalier Universitaire de Nice

  PRINCIPAL INVESTIGATOR

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: February 14, 2023
• First Posted: March 8, 2023
• Study Start: June 13, 2023
• Primary Completion: May 22, 2025
• Study Completion: June 6, 2025
• Last Updated: February 9, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)