Electronic Distraction for ICU Patients

NCT04017299 | Completed

• 1 other identifier: RECHMPL18_0218
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Adult ICU Patients

Keywords

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

Outcome Measures

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

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

Secondary Outcomes (6)

• 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)

• Variation of Respiratory rate during the use of each device

  up to 20 minutes (after the device use )

• Variation of physiologic Blood pressure during the use of each device

  up to 20 minutes (after the device use )

• Variation of Heart Rate during the use of each device

  up to 20 minutes (after the device use )

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

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

Study Arms (4)

Virtual reality with computer graphics

ACTIVE COMPARATOR

Use of Virtual reality with computer graphics

Other: CHOISIR

Virtual reality with real movies

ACTIVE COMPARATOR

Use of Virtual reality with real movies

Other: CHOISIR

Music therapy (dedicated device and music scores)

ACTIVE COMPARATOR

Use of music therapy (dedicated device and music scores)

Other: CHOISIR

Usual device (TV radio)

OTHER

usual distraction : watching TV

Other: CHOISIR

Interventions

CHOISIR 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); Usual device (TV radio); Virtual reality with computer graphics; Virtual reality with real movies

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patient admitted in intensive care unit,
• adult,
• French speaking,
• awake (RASS ≥ -1),
• not delirious (CAM-ICU negative),

You may not qualify if:

• patient refusal
• psychosis or preexisting cognitive dysfunction
• cerebral injury,
• hygiene/microbiological harm,
• pregnancy,
• decision of withdrawal of care

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

University of Montpellier Hospital

Montpellier, 34295, France

Location

MeSH Terms

Conditions

Pain; Anxiety Disorders; Dyspnea

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory

Study Officials

• Gérald CHANQUES, PhD

  University of Montpellier Hospitals

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2019
• First Posted: July 12, 2019
• Study Start: July 17, 2019
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: October 3, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Time Frame: 12 months after the main publication
• Access Criteria: Data are provided to qualified investigators free of charge. Required documents to request data include a summary of the research plan, request form, and IRB review. Dataset will be shared after careful examination by the study board of investigators.

Locations

FR (1)