Audiovisual Distraction in Intensive Care

NCT ID: NCT07013877

Last Updated: 2026-01-30

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 456 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-07-31
• Study Completion Date: 2028-10-31

Brief Summary

Resuscitation patients are subject to constant stress of multifactorial origin: their state of health, the noisy environment of critical care, the multiple examinations and care provided, lack of sleep, stress from their loved ones... It is estimated that 60% of resuscitation patients have experienced stress and 40% have been anxious during their hospitalization in intensive care. This permanent anxiety is punctuated by stress peaks, particularly at the time of invasive procedures frequently performed in the ICU.

This stress is said to have a negative impact on patients' ability to recover and on their length of stay in the ICU. What's more, these anxious symptoms can persist after hospitalization, leading to post-traumatic stress disorder. It therefore seems appropriate to find solutions aimed at reducing this stress.

Medication is often used to reduce stress and anxiety. Although effective, these molecules have undesirable side-effects and can also hinder the patient's recovery.

Alternative methods are already being studied as replacement or supplementary therapies to drugs. These include music therapy, aromatherapy, hypnosis and virtual reality.

Virtual reality has been used on resuscitation patients to improve tolerance to mechanical ventilation and to the resuscitation environment in general.

Conditions

Anxiety

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

"Group with RELAX glasses"

To facilitate immersion, RELAX goggles will be placed on the patient if he or she has been randomized to the "RELAX Goggles Group" immediately after the investigator's assessment of anxiety and pain.

During the use of RELAX glasses, content will be proposed:

• Regional reports. The choice of region will be left to the patient.
• Animal reports. The choice will be left to the patient.
• Relaxation videos. The choice will be left to the patient.

RELAX glasses will be removed at the end of the invasive treatment.

Group Type: EXPERIMENTAL

RELAX glasses

Intervention Type: BEHAVIORAL

Glasses which are a solution of audiovisual sedation by positiv distraction for hospital medical use

Control group without glasses RELAX

Nothing more happens than the usual treatment

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

RELAX glasses

Glasses which are a solution of audiovisual sedation by positiv distraction for hospital medical use

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Patients hospitalized in intensive care, post-operative intensive care and continuous monitoring;
• Patient receiving invasive care placement of peripheral venous line, nasogastric tube insertion, bladder catheterization, dressing stage IV pressure sores, heavy dressing lasting > 15 minutes arterial gasometry by puncture;
• Patient of legal age;
• Patient with written consent;
• Patient with Glasgow score equal to 15;
• Socially insured patient;
• Patient willing to comply with all study procedures and duration.

Exclusion Criteria

• Medical history contraindicating RELAX eyewear;
• Known and current abuse of alcohol and/or illicit drugs that may interfere with patient safety and/or compliance;
• Any condition that would make the patient unsuitable for the study: current presence of cognitive disorders (MMS < 15), severe psychiatric disorders (bipolar disorders, psychotic disorders according to DSM-V classification);
• Major anxiety requiring anxiolytic medication prior to invasive care;
• Patient under court protection;
• Patient participating in another study;
• Patient who has already participated in the DARE study.
• Patient's refusal to use glasses;
• Visually impaired or blind patient.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier de Valenciennes

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

2023-02-03

Identifier Type: -

Identifier Source: org_study_id