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NCT Number: NCT07013877

Audiovisual Distraction in Intensive Care

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.

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Key information

Conditions

Anxiety Anxiety Disorders Mental Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

RELAX glasses

Behavioral

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

Primary outcomes

  1. 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

    The difference in anxiety between the 2 groups will be measured using a visual analog anxiety scale (A mark of 0 indicates 'no anxiety', a mark of 10 indicates 'maximum anxiety)

Secondary outcomes

  1. To compare the evolution of patient pain during invasive care in intensive care, post-operative intensive care and continuous monitoring between the experimental group and the control group

    Time frame: Patient's pain 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 pain

    Change in pain level will be measured by the difference between before and after invasive care. Pain level will be measured using a visual analog scale (The score 0 expresses 'no pain', the score 10 reflects 'maximum imaginable pain)

  2. To compare the number of placement attempts during invasive care in the ICU, post-operative intensive care and continuous monitoring, between the 2 groups

    Time frame: As soon as the invasive procedure has been completed, regardless of the randomization group, the investigator will also complete the document recording the number of trial(s) required to perform the invasive procedure

    Number of placement attempts during invasive care

  3. Compare overall patient satisfaction after invasive care between experimental and control groups

    Time frame: Patient satisfaction will be asked immediately after the invasive treatment. An envelope will be given to the patient, who will be able to rate his or her overall satisfaction on a visual analog scale, without feeling influenced by the nurse

    Overall patient satisfaction will be measured by a visual analog scale (A score of 0 indicates 'not satisfied', while a score of 10 reflects 'maximum satisfaction)

  4. To evaluate nursing staff satisfaction after invasive care in a patient wearing glasses

    Time frame: As soon as the invasive treatment has been completed, the nurse completes the satisfaction questionnary

    Nurse satisfaction will be assessed by a self-assessment questionnaire after each invasive procedure (A score of 0 means that it was 'not at all difficult', while a score of 10 means that it was 'extremely difficult)

  5. Evaluate the impact of patient agitation on the performance of invasive care between the 2 groups

    Time frame: As soon as the invasive treatment has been completed, regardless of the randomization group, the investigator also completes the patient agitation evaluation questionnary.

    In the 2 groups, patient agitation during invasive care will be assessed using a questionnaire completed by the nursing staff

    • The patient has not been agitated
    • The patient was agitated but this had no impact on invasive care
    • Patient agitation was the cause of a change in invasive care
    • Patient agitation was the cause of a temporary suspension of invasive care
    • The patient's agitation is too great to consider continuing the treatment.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier de Valenciennes

Network

Registry information

Official study title

Evaluation of the Impact of the Use of RELAX Glasses on Patients' Anxiety During Invasive Care in Intensive Care, Post-operative Intensive Care and Continuous Monitoring

Acronym: DARE

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jun 10, 2025
Registry last updated
Jan 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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