Audiovisual Distraction in Intensive Care (DARE)

Centre Hospitalier de Valenciennes

Status: Begins enrollment in 4 months

Conditions: Anxiety

Treatments: Behavioral: RELAX glasses

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT07013877

2023-02-03

Details and patient eligibility

About

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.

Enrollment: 456 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

456 participants in 2 patient groups

"Group with RELAX glasses"

Experimental group

Description:

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.

Treatment:

Behavioral: RELAX glasses

Control group without glasses RELAX

No Intervention group

Description:

Nothing more happens than the usual treatment