Audiovisual Distraction in Intensive Care

Sponsor
Centre Hospitalier de Valenciennes
Study ID
NCT07013877
Status
Not Yet Recruiting

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Conditions

  • Anxiety

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • RELAX glasses — BEHAVIORAL
    Glasses which are a solution of audiovisual sedation by positiv distraction for hospital medical use

Study Details

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.

Key Dates

First listed
Jun 10, 2025
Start date
Jul 31, 2026
Status verified
Jan 2026
Primary completion
Oct 31, 2028
Completion
Oct 31, 2028

Study Design

Enrollment
456 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: "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.
  • No Intervention: Control group without glasses RELAX
    Nothing more happens than the usual treatment

Primary Outcome Measure

Show that the use of RELAX glasses reduces anxiety in patients undergoing invasive care in the intensive care unit, postoperative intensive care unit and continuous care unit (experimental group), compared with patients undergoing usual care without R [ Time Frame: Patient anxiety will be assessed by the investigator immediately after the treatment has been explained. As soon as the invasive treatment has been completed, regardless of the randomization group, the investigator will reassess the patient's anxiety ]

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