Clinical trial NCT04017299: Electronic Distraction for ICU Patients
Official title: Choose an Electronic Distraction, Faisability and Discomfort Improvement Evaluation by and for ICU Patients : a Cross Over Randomized Controlled Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adult ICU Patients
Keywords: ICU
Pain
Anxiety
Thirst
Dyspnea
Sleep
Discomfort
Distress
Virtual Reality
Music Therapy
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2019-07-12
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: Just after the use of each device (up to 20 minutes)
Secondary outcomes:
measure: Variation of physiologic parametres (Heart Rate, Blood pressure, Respiratory rate and Analgesia nociception Index), evaluation of feasibility and feelings concerning the distraction devices.
timeFrame: ICU discharge (up to Day 28)
measure: Variation of Respiratory rate during the use of each device
timeFrame: up to 20 minutes (after the device use )
measure: Variation of physiologic Blood pressure during the use of each device
timeFrame: up to 20 minutes (after the device use )
measure: Variation of Heart Rate during the use of each device
timeFrame: up to 20 minutes (after the device use )
measure: evaluation of feasibility assessed by the Numeric Rating Scale from 0 to 10
timeFrame: just after the use of each device (up to 20 minutes)
measure: Evaluation of the feelings concerning the distraction devices assessed by the Numeric Rating Scale from 0 to 10
timeFrame: ICU discharge or up to Day 28
Other outcomes:
Locations:
city: Montpellier
country: France
facility: University of Montpellier Hospital
Study officials:
affiliation: University of Montpellier Hospitals
name: Gérald CHANQUES, PhD
role: PRINCIPAL_INVESTIGATOR
References: