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Combination of Music and Relaxing Light on the Patient's Anxiety After Cardiac Surgery in the Intensive Care Unit (RéaRelax)

P

Poitiers University Hospital

Status

Unknown

Conditions

Delirium
Heart; Surgery, Heart, Functional Disturbance as Result
Pain, Postoperative
Anxiety

Treatments

Other: relaxation session combining music and soft light

Study type

Interventional

Funder types

Other

Identifiers

NCT05178680
RéaRelax

Details and patient eligibility

About

Cardiac surgery is not trivial. It requires opening the thorax in certain indications: coronary artery bypass grafting, valve replacements or plasties, aortic dissection, etc. These different procedures, both pre- and post-op, generate anxiety in the patient, the effects of which can be harmful to the recovery process and general well-being. It can be increased by the resuscitation environment during the immediate postoperative management. This environment also favors the development of delirium. It is possible to improve this environment by using non-drug and inexpensive techniques. Indeed, making the stay in the ICU better while respecting the safety of the patient and the efficiency of the care, could reduce anxiety as well as the appearance of delirium. Studies have been carried out on the effectiveness of music in health care with a positive impact on anxiety and pain.

The proposed study aims to evaluate the implementation of relaxation moments adapted to the resuscitation sector from the day after surgery. They target the senses available and accessible at that moment, such as hearing (relaxing music chosen by the patient will be played) and sight (a multi-effect light projector and a bubble column will be deployed). Environmental stressors will be minimized, while maintaining an optimal level of safety.

The primary objective is to compare anxiety before and after the first session in cardiac surgery patients in the cardiothoracic and vascular surgery (CCTV) resuscitation unit between the group with the usual rest session and the group with the rest session combining soft music and light.

The secondary objectives are based on an evaluation of anxiety over different time periods, patient comfort, occurrence of postoperative delirium, patient pain, average length of stay (LOS).

This is a pilot, comparative, monocentric, randomized, interventional research with minimal risks and constraints in 2 parallel groups. 110 patients will be included over a period of 12 months In the experimental group, once a day, a relaxation session with the association of soft music and light will be proposed by adapting the environment of the patient's resuscitation room. The control group will have the usual rest session.

Enrollment

110 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Age ≥ 18 years
  • Patient going for scheduled or semi-emergency cardiac surgery: any patient who had an anesthesia consultation for cardiac surgery ≥ 48 hours before surgery (according to the recommendations of the French Society of Anesthesia and Intensive Care)
  • Patient affiliated or beneficiary of a social security plan;
  • Patient without guardianship or curatorship, or subordination.
  • Informed consent signed by the patient after clear and fair information about the study

Exclusion criteria

  • Deaf and/or blind patient
  • Patients with a history of delirium or proven dementia.
  • Persons benefiting from enhanced protection, i.e. minors, persons deprived of their liberty by a judicial or administrative decision, adults under legal protection (guardianship and trusteeship) and finally patients in a vital emergency situation.
  • Pregnant or breastfeeding women, women of childbearing age who do not have effective contraception (hormonal/mechanical: per os, injectable, transcutaneous, implantable, intrauterine device, or surgical: tubal ligation, hysterectomy, total ovariectomy).

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

110 participants in 2 patient groups

relaxation session combining music and soft light
Experimental group
Treatment:
Other: relaxation session combining music and soft light
usual rest session
No Intervention group

Trial contacts and locations

1

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Central trial contact

GIRAULT Aurélie

Data sourced from clinicaltrials.gov

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