Skip to content

Audiovisual Distraction in Intensive Care

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07013877
Acronym
DARE
Enrollment
456
Registered
2025-06-10
Start date
2026-07-01
Completion date
2028-10-01
Last updated
2026-01-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety

Keywords

Audiovisual sedation, anxiety, resuscitation, post-operative intensive care, invasive care, continuous monitoring

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.

Interventions

BEHAVIORALRELAX glasses

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

Sponsors

Centre Hospitalier de Valenciennes
Lead SponsorNETWORK

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
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 RPatient 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 anxietyThe 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

MeasureTime frameDescription
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 groupPatient'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 painChange 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)
To compare the number of placement attempts during invasive care in the ICU, post-operative intensive care and continuous monitoring, between the 2 groupsAs 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 procedureNumber of placement attempts during invasive care
Compare overall patient satisfaction after invasive care between experimental and control groupsPatient 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 nurseOverall 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)
To evaluate nursing staff satisfaction after invasive care in a patient wearing glassesAs soon as the invasive treatment has been completed, the nurse completes the satisfaction questionnaryNurse 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)
Evaluate the impact of patient agitation on the performance of invasive care between the 2 groupsAs 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 1. The patient has not been agitated 2. The patient was agitated but this had no impact on invasive care 3. Patient agitation was the cause of a change in invasive care 4. Patient agitation was the cause of a temporary suspension of invasive care 5. The patient's agitation is too great to consider continuing the treatment.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026