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

Anxiety Clinical Trial

— RéaRelax  

Official title:

Impact of the Combination of Music and Relaxing Light on the Patient's Anxiety Postoperatively After Cardiac Surgery in the Intensive Care Unit: Randomized Pilot Study.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05178680
• Other study ID #: RéaRelax
• Status: Recruiting
• Phase: N/A
• Start date: May 13, 2022
• Est. completion date: June 2023

Study information

• Verified date: May 2022
• Source: Poitiers University Hospital
• Contact: GIRAULT Aurélie
• Phone: 05 49 44 36 52
• Email: aurelie.girault[@]chu-poitiers.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 110
• Est. completion date: June 2023
• Est. primary completion date: May 13, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

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

Intervention

Other:
• relaxation session combining music and soft light
The caregiver will install a device consisting of a light bubble column, a multicolored light projector, and relaxing music chosen by the patient from a proposed panel. This session will last 30 minutes the day after the surgery

Locations

Country	Name	City	State
France	Réanimation cardio-thoracique	Poitiers

Sponsors (1)

Lead Sponsor	Collaborator
Poitiers University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	State Tait Anxiety Inventory Measure before and after the 1st session in patients undergoing cardiac surgery, in the intensive care unit for cardio thoracic and vascular surgery	the difference in the result of the anxiety assessment before and after the 1st session with state-Trait Anxiety Inventory Y	5 days