Clinical trial NCT05759026: Comparison of the Benefits of a Personalized Intervention (Virtual Environment and Device) Compared to Usual Care
Official title: The Management of Pain and Anxiety, Using Virtual Reality, During the Care of Elderly Hospitalized Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Elderly
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2023-03-08
Enrollment: 120
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Visual Analog Scale (VAS) - Pain and Anxiety
timeFrame: immediatly before care
measure: Visual Analog Scale (VAS) - Pain and Anxiety
timeFrame: immediatly after care
Secondary outcomes:
measure: HAD scale (Hospital Anxiety Depression scale)
timeFrame: immediately beafore care
measure: HAD scale (Hospital Anxiety Depression scale)
timeFrame: immediately after care
measure: Algo Plus Scale
timeFrame: during care
measure: Heart rate measurment with Oximeter
timeFrame: 2 minutes before the medicale procedure
measure: Heart rate measurment with Oximeter
timeFrame: 2 minutes after the medicale procedure
measure: Respiratory rate with Oximeter
timeFrame: 2 minutes before the medicale procedure
measure: Respiratory rate with Oximeter
timeFrame: 2 minutes after the medicale procedure
measure: Digital scale of care completion
timeFrame: after each care
measure: System Usability Scale (SUS)
timeFrame: at the end of the study
Other outcomes:
Locations:
city: Nice
country: France
facility: CHU de Nice - Hopital de Cimiez
Study officials:
affiliation: Centre Hospitalier Universitaire de Nice
name: Olivier GUERIN
role: PRINCIPAL_INVESTIGATOR
References: