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

NCT05178680 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2022-05-26

No results posted yet for this study

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.

Conditions

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

Interventions

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

Sponsors & Collaborators

  • Poitiers University Hospital

    lead OTHER

Principal Investigators

  • GIRAULT Aurélie · CHU Poitiers

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-13
Primary Completion
2023-05-13
Completion
2023-06-30

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05178680 on ClinicalTrials.gov