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

Primary Purpose

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

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
relaxation session combining music and soft light
Sponsored by
Poitiers University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Heart; Surgery, Heart, Functional Disturbance as Result focused on measuring unit intensive care, heart surgery, anxiety, pain, delirium, non medicinal technique, music, light

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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).

Sites / Locations

  • Réanimation cardio-thoraciqueRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

relaxation session combining music and soft light

usual rest session

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
December 16, 2021
Last Updated
May 19, 2022
Sponsor
Poitiers University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05178680
Brief Title
Combination of Music and Relaxing Light on the Patient's Anxiety After Cardiac Surgery in the Intensive Care Unit
Acronym
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.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 13, 2022 (Actual)
Primary Completion Date
May 13, 2023 (Anticipated)
Study Completion Date
June 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Poitiers University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart; Surgery, Heart, Functional Disturbance as Result, Anxiety, Pain, Postoperative, Delirium
Keywords
unit intensive care, heart surgery, anxiety, pain, delirium, non medicinal technique, music, light

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
110 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
relaxation session combining music and soft light
Arm Type
Experimental
Arm Title
usual rest session
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
relaxation session combining music and soft light
Intervention Description
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
Primary Outcome Measure Information:
Title
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
Description
the difference in the result of the anxiety assessment before and after the 1st session with state-Trait Anxiety Inventory Y
Time Frame
5 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
GIRAULT Aurélie
Phone
05 49 44 36 52
Ext
+33
Email
aurelie.girault@chu-poitiers.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GIRAULT Aurélie
Organizational Affiliation
CHU Poitiers
Official's Role
Principal Investigator
Facility Information:
Facility Name
Réanimation cardio-thoracique
City
Poitiers
ZIP/Postal Code
86021
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
GIRAULT Aurélie
Email
aurelie.girault@chu-poitiers.fr

12. IPD Sharing Statement

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

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