Electronic Distraction for ICU Patients

Not Applicable

Completed

• Conditions: Adult ICU Patients
• Interventions: Other: CHOISIR

• Registration Number: NCT04017299
• Lead Sponsor: University Hospital, Montpellier

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2019-07-05
• Study First Submitted QC: 2019-07-11
• Study First Posted: 2019-07-12
• Study Start: 2019-07-17
• Primary Completion: 2019-12-31
• Study Completion: 2019-12-31
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-09
• Last Update Posted: 2020-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Virtual reality with computer graphics	CHOISIR	Use of Virtual reality with computer graphics
Virtual reality with real movies	CHOISIR	Use of Virtual reality with real movies
Music therapy (dedicated device and music scores)	CHOISIR	Use of music therapy (dedicated device and music scores)
Usual device (TV radio)	CHOISIR	usual distraction : watching TV

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Variation of physiologic Blood pressure during the use of each device	up to 20 minutes (after the device use )	Blood pressure : mmHg
Variation of Respiratory rate during the use of each device	up to 20 minutes (after the device use )	Respiratory rate : c/min
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 Heart Rate during the use of each device	up to 20 minutes (after the device use )	Heart Rate : b/min
evaluation of feasibility assessed by the Numeric Rating Scale from 0 to 10	just after the use of each device (up to 20 minutes)	Numeric Rating Scale from 0 to 10
Evaluation of the feelings concerning the distraction devices assessed by the Numeric Rating Scale from 0 to 10	ICU discharge or up to Day 28	Numeric Rating Scale from 0 to 10

Trial Locations

Locations (1)

University of Montpellier Hospital; 🇫🇷 Montpellier, France