AnxietyDARENCT07013877
Audiovisual Distraction in Intensive Care
A study testing RELAX glasses in people with Anxiety, run by Centre Hospitalier de Valenciennes.
Trial 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... Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anxiety
- What is being tested?
- RELAX glasses
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 456 participants
- Where
- No sites listed yet
- Study dates
- Jul 2026to Oct 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- Patient who has already participated in the DARE study.
- Patient's refusal to use glasses;
- Visually impaired or blind patient.
About this study
Official 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
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.
Read more
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
- Being tested
- RELAX glasses
- Keywords
- Audiovisual sedation, anxiety, resuscitation, post-operative intensive care, invasive care, continuous monitoring
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RELAX glassesBehavioural
Glasses which are a solution of audiovisual sedation by positiv distraction for hospital medical use
| Study group | Role | What they receive |
|---|---|---|
| "Group with RELAX glasses" | Experimental | 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. Receives: Behavioral: RELAX glasses |
| Control group without glasses RELAX | No intervention | Nothing more happens than the usual treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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)
Measured: 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
Secondary outcomes (5)
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
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)
Measured: 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
To compare the number of placement attempts during invasive care in the ICU, post-operative intensive care and continuous monitoring, between the 2 groups
Number of placement attempts during invasive care
Measured: 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
Compare overall patient satisfaction after invasive care between experimental and control groups
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)
Measured: 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
To evaluate nursing staff satisfaction after invasive care in a patient wearing glasses
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)
Measured: As soon as the invasive treatment has been completed, the nurse completes the satisfaction questionnary
Evaluate the impact of patient agitation on the performance of invasive care between the 2 groups
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.
Measured: As soon as the invasive treatment has been completed, regardless of the randomization group, the investigator also completes the patient agitation evaluation questionnary.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2025
- Study startJul 2026 (estimated)
- Primary completionOct 2028 (estimated)
- Study completionOct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 456 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier de Valenciennes
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07013877
- Sponsor's protocol ID
- 2023-02-03
- Acronym
- DARE
- Status last verified
- Jan 2026
- First submitted
- 2 Jun 2025
- Last updated
- 30 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07013877
- Acronym / sponsor ID
- DARE / 2023-02-03
- Conditions
- Anxiety
- Keywords
- Audiovisual sedation, anxiety, resuscitation, post-operative intensive care, invasive care, continuous monitoring
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 456 participants (estimated)
- Lead sponsor
- Centre Hospitalier de ValenciennesResearch network
- Study start
- Jul 2026 (estimated)
- Primary completion
- Oct 2028 (estimated)
- Study completion
- Oct 2028 (estimated)
- First posted
- 10 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| "Group with RELAX glasses" | Experimental | Behavioral: RELAX glassesTo 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. |
| Control group without glasses RELAX | No intervention | –Nothing more happens than the usual treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RELAX glassesGlasses which are a solution of audiovisual sedation by positiv distraction for hospital medical use | Behavioural | "Group with RELAX glasses" |
Primary outcome
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)
5 secondary outcomes
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
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
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
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
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing RELAX glasses in people with Anxiety, run by Centre Hospitalier de Valenciennes.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2026.