Electronic Distraction for ICU Patients

Adult ICU Patients Clinical Trial

— CHOISIR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04017299
• Other study ID #: 7667
• Status: Completed
• Phase: N/A
• Start date: July 17, 2019
• Est. completion date: December 31, 2019

Study information

• Verified date: July 2020
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adult ICU Patients

Intervention

Other:
• CHOISIR
Every patient will evaluate each device after 15 minutes of distraction once or twice a day according to the patient's wishes.

Locations

Country	Name	City	State
France	University of Montpellier Hospital	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	Variation of Respiratory rate during the use of each device	Respiratory rate : c/min	up to 20 minutes (after the device use )
Secondary	Variation of physiologic Blood pressure during the use of each device	Blood pressure : mmHg	up to 20 minutes (after the device use )
Secondary	Variation of Heart Rate during the use of each device	Heart Rate : b/min	up to 20 minutes (after the device use )
Secondary	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)
Secondary	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