Health TrialsbyHealthPanel

Audiovisual Distraction in Intensive Care

ConditionAnxiety
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre Hospitalier de Valenciennes

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • RELAX glasses

    Behavioral

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

Treatment groups

456 Participants
are divided into 2 treatment groups
Group A: "Group with RELAX glasses"Experimental treatment 1 intervention
Group B: Control group without glasses RELAXNo intervention 0 interventions

Trial outcomes

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

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)

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

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

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)

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
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

Number of placement attempts during invasive care

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
3

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)

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
4

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)

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Centre Hospitalier de Valenciennes

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: