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

Elderly Clinical Trial

— ADA-VRSPA  

Official title:

The Management of Pain and Anxiety, Using Virtual Reality, During the Care of Elderly Hospitalized Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05759026
• Other study ID #: 22-PP-23
• Status: Recruiting
• Phase: N/A
• Start date: June 13, 2023
• Est. completion date: January 13, 2026

Study information

• Verified date: May 2023
• Source: Centre Hospitalier Universitaire de Nice
• Contact: Olivier GUERIN
• Phone: 04 92 03 41 94
• Email: guerin.o[@]chu-nice.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: January 13, 2026
• Est. primary completion date: December 13, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Elderly

Intervention

Other:
• Accompaing cares
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).

Locations

Country	Name	City	State
France	CHU de Nice - Hopital de Cimiez	Nice

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	HAD scale (Hospital Anxiety Depression scale)	This scale evaluates the anxiety that a subject presents, only in a given situation. This tool proposes statements to patients who must then indicate whether their current state corresponds to this statement. The patients can answer from 0 to 3 according to their current feeling. This questionnaire includes 7 items allowing to evaluate the anxiety of the patient. Higher score and worse score: 21	immediately beafore care
Secondary	HAD scale (Hospital Anxiety Depression scale)	This scale evaluates the anxiety that a subject presents, only in a given situation. This tool proposes statements to patients who must then indicate whether their current state corresponds to this statement. The patients can answer from 0 to 3 according to their current feeling. This questionnaire includes 7 items allowing to evaluate the anxiety of the patient. Higher score and worse score : 21	immediately after care
Secondary	Algo Plus Scale	The algoplus scale is a scale assessing pain in five categories of behaviors to be observed: face, gaze, complaints, body and general behavior. Only one behavior in a category needs to be observed to be considered active. Each active category, regardless of the number of behaviors observed, counts as one point. This scale evaluates from 0 (minimum score) to 5 (maximum score). The presence of pain is diagnosed if the total score is greater than or equal to 2	during care
Secondary	Heart rate measurment with Oximeter	The heart rate is measured with the number of pulses per minute. This measurement aims to evaluate the changes in the heart rate that may be related to an emotional response (positive or negative) related to the care and / or the intervention implemented (VR and / or tablet).	2 minutes before the medicale procedure
Secondary	Heart rate measurment with Oximeter	The heart rate is measured with the number of pulses per minute. This measurement aims to evaluate the changes in the heart rate that may be related to an emotional response (positive or negative) related to the care and / or the intervention implemented (VR and / or tablet).	2 minutes after the medicale procedure
Secondary	Respiratory rate with Oximeter	The respiratory rate is the number of respiratory cycles (inhalation and exhalation) per unit of time, of each individual. This measurement aims to observe changes in the breathing rhythm related to a strong emotion (positive or negative) that could be related to the care and/or the intervention implemented.	2 minutes before the medicale procedure
Secondary	Respiratory rate with Oximeter	The respiratory rate is the number of respiratory cycles (inhalation and exhalation) per unit of time, of each individual. This measurement aims to observe changes in the breathing rhythm related to a strong emotion (positive or negative) that could be related to the care and/or the intervention implemented.	2 minutes after the medicale procedure
Secondary	Digital scale of care completion	After treatment, a numerical scale will be proposed to the caregiver who performed the treatment, in order to evaluate the performance of the treatment (difficulties, observation of the patient: discomfort/pain, quality of treatment). The associate investigator will then ask the caregiver to rate each item from 0 to 10. Worse outcome : 10	after each care
Secondary	System Usability Scale (SUS)	To obtain the SUS score, the contributions to the score of each item must first be added together. The contribution to the score of each item ranges from 1 to 5. For items 1, 3, 5, 7, and 9, the contribution to the score is equal to the position on the scale minus 1. For items 2,4,6,8, and 10, the contribution is 5 minus the position on the scale.Multiply the sum of the scores by 2.5 to get the overall SU value. SUS scores range from 0 to 100. The higher the score, the greater the acceptability and usability	at the end of the study