Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Anxiety and discomfort generated by repeated medical cares and invasive procedures can induce cognitive disorders in critical illness survivors as post-traumatic stress disorder. For this reason, managing patients' anxiety is particularly important in the intensive care unit. Physicians have recently started using immersive virtual reality (VR), based on real-time interaction with an artificial 360° immersive world, as an adjunctive non-invasive and non-pharmacological anxiolysis technique. The purpose of this project is to assess the virtual reality stimulation to reduce anxiety in Intensive Care Unit (ICU) patients.
Physicians have recently started using immersive VR as an adjunctive non-invasive and non-pharmacological pain control and anxiolysis technique, but the literature on this topic in the adult ICU is quite sparse. In a pilot study, Gerber et al showed the feasibility and acceptance of VR stimulation as a new non-pharmacological intervention to comfort patients during their stay in the ICU and the results appear promising [11]. In our view, the management of anxiety related to healthcare interventions remains a major global challenge and it will be interesting to assess the use of VR in a chronic daily use in the ICU adult patients. Our study will be conducted in the adult intensive care unit of the University of Toulouse, France. All patients who meet the inclusion criteria will be randomized. There will be two distinct groups: the control group will receive standard ICU care, whereas the intervention group will, in addition to the standard ICU care, will receive relaxing VR stimulation two times a day. The intervention will be performed by trained ICU nurses. Anxiety will be assessed by the Visual Analogue Scale for Anxiety (VAS-A) twice by day (morning and evening), sleep quality with the Richards-Campbell Sleep Questionnaire (RCSQ) every morning, depression, and anxiety with the Hamilton Depression Rating Scale (HDRS) and the Hamilton Anxiety Rating Scale (HAM-A) at 3-months after the inclusion. Each patient's heart rate, blood pressure, respiration rate, SatO2, and physical or neurocognitive side effects were used to evaluate if the VR sessions will have any effect on physiology.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group: | No Intervention | Standard intensive care unit care without virtual reality stimulation. | |
| Interventional group: | Experimental | Standard intensive care unit care and 30 minutes of virtual reality stimulation two times per day. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Virtual Reality | Other | The intervention will consist of relaxing virtual reality stimulation, which will be started after obtaining informed consent. Immersive 360-degree videos (nature environments) will be played inside a head-mounted display, with the video sound played inside headphones. Each virtual reality video will last 30 minutes. The stimulation will be provided two times per day, morning and evening, every day until the patient ICU discharge, or the maximum of 7 days will be reached. The intervention group will also receive standard intensive care unit care, same as in the control group. |
| Measure | Description | Time Frame |
|---|---|---|
| Patients' anxiety level after using virtual reality | Visual Analogue Scale for Anxiety (VAS-A) is a scale measuring anxiety from 0 to 100 ; 0: no anxiety, 100: maximum of anxiety | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in patient anxiety after using virtual reality | Visual Analogue Scale for Anxiety (VAS-A) variations between inclusion and the day 7. The VAS A is a scale measuring anxiety from 0 to 100 ; 0: no anxiety, 100: maximum of anxiety | between inclusion and the day 7 |
| Evolution of the psychopathological status: depression |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Floriane PUEL, Dr | Contact | 05 61 32 22 25 | puel.f@chu-toulouse.fr |
| Name | Affiliation | Role |
|---|---|---|
| Floriane PUEL, Dr | Hôpital Rangueil, CHU de Toulouse | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital of Toulouse | Toulouse | France |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D003863 | Depression |
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D020919 | Sleep Disorders, Intrinsic |
Not provided
Not provided
Clinical interventional trial, randomized, monocentric in the Intensive Care Unit of Toulouse University Hospital.
Not provided
Not provided
Not provided
Not provided
|
Score to the Hamilton Depression Rating Scale (HDRS) with 16 items from 0 (no symptom) to 4 (high symptom of depression) with a total score from 0 to 30: 0 no depression / 30: depression maximum |
| 3 months |
| Evolution of the psychopathological status: anxiety | Score to the Hamilton Anxiety Rating Scale (HAM-A) with 14 items rom 0 (no symptom) to 4 (high symptom of depression) with a total score from 0 to 56: 0 no anxiety /56: anxiety maximum | 3 months |
| Evolution of the Sleep quality | Score to the Richards-Campbell Sleep Questionnaire (RCSQ) from 0 to 100 (0: worse sleep /100: best sleep | every day through study completion, an average of 5 days |
| Evaluation of the Safety of using vitural reality in intensive care unit | Number of side effects that may occur during a VR session | every day through study completion, an average of 5 days |
| Evaluation of the compliance | Number of virtual reality sessions actually performed by the patient in the intervention group | 3 months |
| D020920 |
| Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |