ADA-VRSPA: Comparison of the Benefits of a Personalized Intervention (Virtual Environment and Device) Compared to Usual Care
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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. During this visit, the patient will be randomized so that the order of the intervention phases, during step 1, will be determined in a random way (A (control), B (headset - not personalized) and C (touch pad - not personalized).
Step 1: The participant will be managed during 3 treatments : one in control condition, one with the VR headset and one with the tablet, for an average of 30 minutes per care (including the completion of the scales and questionnaires)
Step 2: The results (anxiety and pain) of step 1 will determine which material presents the best results (headset or tablet). During phase D, the participant will be accompanied during a treatment with a personalized material and environment. The duration of the session is estimated at 30 minutes, including the completion of the scales and the care.
After each treatment, the caregiver who performed the treatment will be asked to answer a questionnaire in order to evaluate the execution of the care. At the end of the study, a questionnaire (SUS) will be proposed to the caregivers who took part in the study to evaluate their acceptability of the technologies used (headset and tablet).
The participant will be seen a maximum of 6 times over a period of two months (maximum duration estimated according to the recurrence of care (almost daily or weekly)).
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: control condition - with VR - with Tablet The patient will be randomized so that the order of the 3 interventions, during step 1, will be determined in a random way. |
Other: Accompaing cares
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 (e.g. landscapes, animals...).
Step 1: The participant will be managed during 3 cares : one care in control condition (no material used), one care with the VR headset and one care with the tablet, for an average of 30 minutes per care (including the completion of the scales and questionnaires).
During this step the environnement played on the tablet and with the VR headset is not personnalized.
Step 2: Based on the results (anxiety and pain) of step 1, determination of the material that presents the best results (VR headset or tablet).
The participant will be accompanied during one care with the material that gave the best results on pain and anxiety level. The material will play the personalized environment the patient chose at inclusion
|
| Experimental: with VR - control condition - with tablet The patient will be randomized so that the order of the 3 interventions, during step 1, will be determined in a random way. |
Other: Accompaing cares
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 (e.g. landscapes, animals...).
Step 1: The participant will be managed during 3 cares : one care in control condition (no material used), one care with the VR headset and one care with the tablet, for an average of 30 minutes per care (including the completion of the scales and questionnaires).
During this step the environnement played on the tablet and with the VR headset is not personnalized.
Step 2: Based on the results (anxiety and pain) of step 1, determination of the material that presents the best results (VR headset or tablet).
The participant will be accompanied during one care with the material that gave the best results on pain and anxiety level. The material will play the personalized environment the patient chose at inclusion
|
| Experimental: with tablet - control condition - with VR The patient will be randomized so that the order of the 3 interventions, during step 1, will be determined in a random way. |
Other: Accompaing cares
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 (e.g. landscapes, animals...).
Step 1: The participant will be managed during 3 cares : one care in control condition (no material used), one care with the VR headset and one care with the tablet, for an average of 30 minutes per care (including the completion of the scales and questionnaires).
During this step the environnement played on the tablet and with the VR headset is not personnalized.
Step 2: Based on the results (anxiety and pain) of step 1, determination of the material that presents the best results (VR headset or tablet).
The participant will be accompanied during one care with the material that gave the best results on pain and anxiety level. The material will play the personalized environment the patient chose at inclusion
|
| Experimental: Control condition - with tablet - with VR The patient will be randomized so that the order of the 3 interventions, during step 1, will be determined in a random way. |
Other: Accompaing cares
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 (e.g. landscapes, animals...).
Step 1: The participant will be managed during 3 cares : one care in control condition (no material used), one care with the VR headset and one care with the tablet, for an average of 30 minutes per care (including the completion of the scales and questionnaires).
During this step the environnement played on the tablet and with the VR headset is not personnalized.
Step 2: Based on the results (anxiety and pain) of step 1, determination of the material that presents the best results (VR headset or tablet).
The participant will be accompanied during one care with the material that gave the best results on pain and anxiety level. The material will play the personalized environment the patient chose at inclusion
|
| Experimental: with VR - with tablet - control condition The patient will be randomized so that the order of the 3 interventions, during step 1, will be determined in a random way. |
Other: Accompaing cares
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 (e.g. landscapes, animals...).
Step 1: The participant will be managed during 3 cares : one care in control condition (no material used), one care with the VR headset and one care with the tablet, for an average of 30 minutes per care (including the completion of the scales and questionnaires).
During this step the environnement played on the tablet and with the VR headset is not personnalized.
Step 2: Based on the results (anxiety and pain) of step 1, determination of the material that presents the best results (VR headset or tablet).
The participant will be accompanied during one care with the material that gave the best results on pain and anxiety level. The material will play the personalized environment the patient chose at inclusion
|
| Experimental: with tablet - with VR - control condition The patient will be randomized so that the order of the 3 interventions, during step 1, will be determined in a random way. |
Other: Accompaing cares
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 (e.g. landscapes, animals...).
Step 1: The participant will be managed during 3 cares : one care in control condition (no material used), one care with the VR headset and one care with the tablet, for an average of 30 minutes per care (including the completion of the scales and questionnaires).
During this step the environnement played on the tablet and with the VR headset is not personnalized.
Step 2: Based on the results (anxiety and pain) of step 1, determination of the material that presents the best results (VR headset or tablet).
The participant will be accompanied during one care with the material that gave the best results on pain and anxiety level. The material will play the personalized environment the patient chose at inclusion
|
Outcome Measures
Primary Outcome Measures
- Visual Analog Scale (VAS) - Pain and Anxiety [immediatly before 1st care]
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)
- Visual Analog Scale (VAS) - Pain and Anxiety [immediatly after 1st care]
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)
- Visual Analog Scale (VAS) - Pain and Anxiety [immediatly before 2nde care]
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)
- Visual Analog Scale (VAS) - Pain and Anxiety [immediatly after 2nde care]
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)
- Visual Analog Scale (VAS) - Pain and Anxiety [immediatly before 3rd care]
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)
- Visual Analog Scale (VAS) - Pain and Anxiety [immediatly after 3rd care]
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)
- Visual Analog Scale (VAS) - Pain and Anxiety [immediatly before 4th care]
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)
- Visual Analog Scale (VAS) - Pain and Anxiety [immediatly after 4th care]
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)
Secondary Outcome Measures
- HAD scale (Hospital Anxiety Depression scale) [immediatly before each 4 cares]
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
- HAD scale (Hospital Anxiety Depression scale) [immediatly after each 4 cares]
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
- Algo Plus Scale [immediatly before each 4 cares]
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
- Algo Plus Scale [immediatly after each 4 cares]
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
- Heart rate measurment with Oximeter [for each care: 2 minutes before the medicale procedure]
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).
- Heart rate measurment with Oximeter [for each care: during the medicale procedure]
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).
- Heart rate measurment with Oximeter [for each care: 2 minutes after the medicale procedure]
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).
- Respiratory rate with Oximeter [for each care: 2 minutes before the medicale procedure]
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.
- Respiratory rate with Oximeter [for each care: during the medicale procedure]
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.
- Respiratory rate with Oximeter [for each care: 2 minutes after the medicale procedure]
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.
- Digital scale of care completion [after each care]
After each 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
- System Usability Scale (SUS) [at the end of the study]
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
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | CHU de Nice - Hopital de Cimiez | Nice | France | 06000 |
Sponsors and Collaborators
- Centre Hospitalier Universitaire de Nice
Investigators
- Principal Investigator: Olivier GUERIN, Centre Hospitalier Universitaire de Nice
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 22-PP-23