Ignite Creation Date:
2024-05-06 @ 6:43 PM
Last Modification Date:
2024-10-26 @ 2:53 PM
Study NCT ID:
NCT05759026
Status:
RECRUITING
Last Update Posted:
2024-01-30
First Post:
2023-02-14
Brief Title:
Comparison of the Benefits of a Personalized Intervention Virtual Environment and Device Compared to Usual Care
Sponsor:
Centre Hospitalier Universitaire de Nice
Organization:
Centre Hospitalier Universitaire de Nice
Study Overview
Official Title:
The Management of Pain and Anxiety Using Virtual Reality During the Care of Elderly Hospitalized Patients
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ADA-VRSPA
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 environmentEach 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None