Electronic Distraction for ICU Patients

Study Overview
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Brief Summary
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This is a feasibility study of electronic devices in order to reduce neuro-psychological disorders and suffering in intensive care unit (ICU) patients. A first step study is necessary to define which device is effective and safe to reduce symptom intensities, among music therapy, virtual reality with real pictures, virtual reality with artificial pictures, and common devices (radio or television). If some devices are effective to reduce patients' symptoms, a second step will be to implement and assess the impact of these tools in a multicenter trial.

Detailed Description
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Quality of life following intensive care unit discharge is more and more anticipated during the ICU stay. Psychological trauma during ICU stay, related to medical management, can be very deleterious at short and long term, inducing psychological troubles as post-traumatic stress disorder and delaying the return to a normal social and professional life. For this reason, managing patients' distress is particularly important in the intensive care setting. There has been an increasing number of new technologies for the distraction of patients in different settings. a Today, a large amount of electronic distraction is available. TV and radio are available in each ICU, music therapy has already been studied and it is currently used in some ICUs. Virtual reality (VR) is used to improve attention and memory in stroke patients. Furthermore, VR seems to decrease stress post trauma disorders and phobia, as well as pain and anxiety during surgical procedures and physiotherapy. Our first step study will help us to determine which electronic distraction has the most effect on the top five discomfort symptoms frequently observed in ICU: pain, anxiety dyspnea, thirst and sleep privation.

Official Title
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Choose an Electronic Distraction, Faisability and Discomfort Improvement Evaluation by and for ICU Patients : a Cross Over Randomized Controlled Study.

Conditions
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Adult ICU Patients

Intervention / Treatment
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* Other: CHOISIR


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patient admitted in intensive care unit, adult, French speaking, awake (RASS ≥ -1), not delirious (CAM-ICU negative), Exclusion Criteria: patient refusal psychosis or preexisting cognitive dysfunction cerebral injury, hygiene/microbiological harm, pregnancy, decision of withdrawal of care

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Virtual reality with computer graphics<br>Use of Virtual reality with computer graphics | Other: CHOISIR<br>* Every patient will evaluate each device after 15 minutes of distraction once or twice a day according to the patient's wishes.<br>|
| Active Comparator: Virtual reality with real movies<br>Use of Virtual reality with real movies | Other: CHOISIR<br>* Every patient will evaluate each device after 15 minutes of distraction once or twice a day according to the patient's wishes.<br>|
| Active Comparator: Music therapy (dedicated device and music scores)<br>Use of music therapy (dedicated device and music scores) | Other: CHOISIR<br>* Every patient will evaluate each device after 15 minutes of distraction once or twice a day according to the patient's wishes.<br>|
| Other: Usual device (TV radio)<br>usual distraction : watching TV | Other: CHOISIR<br>* Every patient will evaluate each device after 15 minutes of distraction once or twice a day according to the patient's wishes.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Variation of intensity of the 5 discomfort symptoms (pain, anxiety, thirst, dyspnea, insomnia) assessed by a self-report 0-10 visually enlarged numeric rating scale |  | Just after the use of each device (up to 20 minutes) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Variation of physiologic parametres (Heart Rate, Blood pressure, Respiratory rate and Analgesia nociception Index), evaluation of feasibility and feelings concerning the distraction devices. |  | ICU discharge (up to Day 28) | 
| Variation of Respiratory rate during the use of each device | Respiratory rate : c/min | up to 20 minutes (after the device use ) | 
| Variation of physiologic Blood pressure during the use of each device | Blood pressure : mmHg | up to 20 minutes (after the device use ) | 
| Variation of Heart Rate during the use of each device | Heart Rate : b/min | up to 20 minutes (after the device use ) | 
| evaluation of feasibility assessed by the Numeric Rating Scale from 0 to 10 | Numeric Rating Scale from 0 to 10 | just after the use of each device (up to 20 minutes) | 
| Evaluation of the feelings concerning the distraction devices assessed by the Numeric Rating Scale from 0 to 10 | Numeric Rating Scale from 0 to 10 | ICU discharge or up to Day 28 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ICU, Pain, Anxiety, Thirst, Dyspnea, Sleep, Discomfort, Distress, Virtual Reality, Music Therapy