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临床试验/NCT05572437
NCT05572437已完成不适用

Perioperative Effect of Music in Patients Undergoing General Anesthesia

Dr. Negrin University Hospital1 个研究点 分布在 1 个国家目标入组 151 人开始时间: 2022年10月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
151
试验地点
1
主要终点
Perioperative anxiety

研究概览

简要总结

Anxiety is a transient emotional state characterized by feelings of tension, apprehension, nervousness, fear, and heightened activation of the autonomic nervous system in response to a specific current or potential event or situation. Music therapy is a cost-effective and safe intervention applied to health care, that has been incorporated into different branches of medicine, including anesthesiology, showing economic benefits and as an adjunct to pharmacological therapy, allowing the use of lower doses of perioperative drugs, thus reducing their deleterious effects. The main objective of this randomized clinical trial is to evaluate whether the application of music during the perioperative period reduces perioperative anxiety in patients undergoing general and digestive surgery under general anesthesia.Patients between 18 and 60 years of age, classified according to the American Society of Anesthesiologists (ASA) I-IV, scheduled for general surgery and who have signed the informed consent, will be randomized to receive music therapy in the immediate perioperative period or not. Perioperative anxiety, stay in the PACU, incidence of postoperative pain and intraoperative opioid consumption will be compared between both groups.

详细描述

Anxiety is a transient emotional state characterized by feelings of tension, apprehension, nervousness, fear, and heightened activation of the autonomic nervous system in response to a specific current or potential event or situation. Music therapy is a cost-effective, non-invasive and safe intervention applied to health care, whose boom has grown gradually in recent years until it has been incorporated into different branches of medicine, including anesthesiology , showing economic benefits and as an adjunct to pharmacological therapy, since it allows the use of lower doses of some drugs, thus reducing their deleterious effects. The main objective of this randomized clinical trial is to evaluate whether the application of music during the perioperative period reduces perioperative anxiety in patients undergoing general and digestive surgery under general anesthesia. Patients between 18 and 60 years of age, classified according to the American Society of Anesthesiologists (ASA) I-IV, scheduled for general surgery and who have signed the informed consent, will be randomized to receive music therapy in the immediate perioperative period or not. Patients randomized to the control group will be assessed for preoperative anxiety using the APAIS and the STAI scales in the preoperative room and assessment of insomnia using the ISI scale both in the PACU and on the 1st day in the hospital ward. Pain assessment will be measured using the VAS scale in the PACU and on the first day in the hospital ward. Patients randomized to the treatment with music group (classical music), after assessment of anxiety using the APAIS and STAI scales, will be given headphones and classical music will be played from their stay in the pre-surgery room, during surgery and in the PACU.All patients will have their anxiety assessed in the pre-anesthesia room and insomnia assessed both in the PACU and on the 1st day in the hospital ward. Pain assessment will be measured in the PACU and on the first day in the hospitalization ward. Perioperative anxiety, stay in the PACU, incidence of postoperative pain and intraoperative opioid consumption will be compared between both groups.

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
Triple (Care Provider, Investigator, Outcomes Assessor)

盲法说明

El investigador responsable de la recogida de los datos a partir del informe clínico de los anestesiólogos responsables del manejo clínico intra y postoperatorio de los pacientes no sabrá qué pacientes han sido incluidos en el grupo Intervención.

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Patients over 18 years of age and under 60 years of age
  • •Classification of the American Society of Anesthesiologists (ASA) I-IV
  • •Intervened on a scheduled basis for general surgery.
  • •Signed informed consent prior to surgery.

排除标准

  • •Refusal of the patient to participate in the study.
  • •Patients under 18 years of age or incapable of giving their consent.
  • •History of hypersensitivity to contact devices
  • •Patients with total hearing impairment
  • •Patients with substance abuse use disorders
  • •Patients with cognitive deficit

研究组 & 干预措施

Control Group

No Intervention

Patients randomized to the control group will be assessed for preoperative anxiety using the APAIS scale in the preoperative room and assessment of insomnia using the ISI scale both in the PACU and on the 1st day in the hospital ward. Pain assessment will be measured using the VAS scale in the PACU and on the first day on the hospital ward.

Intervention Group

Experimental

Patients randomized to the treatment with music group (classical music), after assessment of anxiety using the APAIS scale, will be given headphones and classical music will be played from their stay in the pre-surgery room, during surgery and in the PACU.

干预措施: Music Therapy (Device)

结局指标

主要结局

Perioperative anxiety

时间窗: from the arrival to the preanesthesia room to the 4 postoperative hour

Specific anxiety questionnaires (APAIS, STAI) will be applied on arrival at the pre-anesthesia room, prior to anesthetic induction and after arrival at the post-anesthetic recovery unit.

次要结局

  • Postoperative pain(From the first postoperative hour to the 4th postoperative hour.)

研究者

发起方
Dr. Negrin University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ángel Becerra

Principal Investigator

Dr. Negrin University Hospital

研究点 (1)

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