跳至主要内容
临床试验/NCT05178680
NCT05178680Unknown不适用

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.

Poitiers University Hospital2 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2022年5月13日最近更新:
适应症

试验速览

阶段
不适用
入组人数
110
试验地点
2
主要终点
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

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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).

结局指标

主要结局

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

时间窗: 5 days

the difference in the result of the anxiety assessment before and after the 1st session with state-Trait Anxiety Inventory Y

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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