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Electronic Distraction for ICU Patients

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04017299
Acronym
CHOISIR
Enrollment
60
Registered
2019-07-12
Start date
2019-07-17
Completion date
2019-12-31
Last updated
2025-10-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adult ICU Patients

Keywords

ICU, Pain, Anxiety, Thirst, Dyspnea, Sleep, Discomfort, Distress, Virtual Reality, Music Therapy

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.

Interventions

OTHERCHOISIR

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

Sponsors

University Hospital, Montpellier
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime 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 scaleJust after the use of each device (up to 20 minutes)

Secondary

MeasureTime frameDescription
Variation of Respiratory rate during the use of each deviceup to 20 minutes (after the device use )Respiratory rate : c/min
Variation of physiologic Blood pressure during the use of each deviceup to 20 minutes (after the device use )Blood pressure : mmHg
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)
evaluation of feasibility assessed by the Numeric Rating Scale from 0 to 10just 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 10ICU discharge or up to Day 28Numeric Rating Scale from 0 to 10
Variation of Heart Rate during the use of each deviceup to 20 minutes (after the device use )Heart Rate : b/min

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026