Electronic Distraction for ICU Patients

NCT ID: NCT04017299

Last Updated: 2025-10-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-17

Study Completion Date

2019-12-31

Brief Summary

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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

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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.

Conditions

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Adult ICU Patients

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Virtual reality with computer graphics

Use of Virtual reality with computer graphics

Group Type ACTIVE_COMPARATOR

CHOISIR

Intervention Type OTHER

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

Virtual reality with real movies

Use of Virtual reality with real movies

Group Type ACTIVE_COMPARATOR

CHOISIR

Intervention Type OTHER

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

Music therapy (dedicated device and music scores)

Use of music therapy (dedicated device and music scores)

Group Type ACTIVE_COMPARATOR

CHOISIR

Intervention Type OTHER

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

Usual device (TV radio)

usual distraction : watching TV

Group Type OTHER

CHOISIR

Intervention Type OTHER

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

Interventions

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CHOISIR

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Montpellier

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gérald CHANQUES, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Montpellier Hospitals

Locations

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University of Montpellier Hospital

Montpellier, , France

Site Status

Countries

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France

Other Identifiers

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RECHMPL18_0218

Identifier Type: -

Identifier Source: org_study_id

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