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

Centre Hospitalier Universitaire de Nice

Status: Enrolling

Conditions: Elderly

Treatments: Other: Accompaing cares

Study type: Interventional

Funder types: Other

Identifiers

NCT05759026

22-PP-23

Details and patient eligibility

About

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.

Full description

The management of pain and anxiety, during care, will be proposed to patients hospitalized in the geriatric department of the Cimiez Hospital in Nice. After signing the consent form, the equipment and the different virtual environments will be presented to the patient and he will choose his preferred environment.Each patient will be accompanied during a treatment (either in control condition, or in VR condition with a VR condition with a personalised environment (VREP), or in VR condition with a environment (VRNP) for an average of 15 minutes (including the completion of the (including the completion of scales and questionnaires). Assessments will be carried out just before the treatment and just after the treatment.

After the treatment, the caregiver will also be asked to complete a scale assessing After the treatment, the carer will also be asked to complete a scale assessing the treatment (2 minutes on average to complete this scale).

And at the end of the study, the caregivers who participated in the study will be asked to rate their acceptability of VR using the User Experience Survey.

Enrollment: 120 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 3 patient groups

control condition

Experimental group

Description:

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

Treatment:

Other: Accompaing cares

with VR

Experimental group

Description:

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

Treatment:

Other: Accompaing cares

with VR personalised

Experimental group

Description:

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

Treatment:

Other: Accompaing cares