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Completed

NCT Number: NCT04017299

Electronic Distraction for ICU Patients

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.

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Key information

Conditions

Adult ICU Patients Anxiety Disorders Dyspnea Mental Disorders Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Montpellier Hospital

Montpellier, 34295, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CHOISIR

Other

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

Primary outcomes

  1. 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

    Time frame: Just after the use of each device (up to 20 minutes)

Secondary outcomes

  1. Variation of physiologic parametres (Heart Rate, Blood pressure, Respiratory rate and Analgesia nociception Index), evaluation of feasibility and feelings concerning the distraction devices.

    Time frame: ICU discharge (up to Day 28)

  2. Variation of Respiratory rate during the use of each device

    Time frame: up to 20 minutes (after the device use )

    Respiratory rate : c/min

  3. Variation of physiologic Blood pressure during the use of each device

    Time frame: up to 20 minutes (after the device use )

    Blood pressure : mmHg

  4. Variation of Heart Rate during the use of each device

    Time frame: up to 20 minutes (after the device use )

    Heart Rate : b/min

  5. evaluation of feasibility assessed by the Numeric Rating Scale from 0 to 10

    Time frame: just after the use of each device (up to 20 minutes)

    Numeric Rating Scale from 0 to 10

  6. Evaluation of the feelings concerning the distraction devices assessed by the Numeric Rating Scale from 0 to 10

    Time frame: ICU discharge or up to Day 28

    Numeric Rating Scale from 0 to 10

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Official study title

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

Acronym: CHOISIR

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jul 12, 2019
Registry last updated
Oct 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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