Clinical trial NCT05572437: Perioperative Effect of Music in Patients Undergoing General Anesthesia
Official title: Perioperative Effect of Music in Patients Undergoing General Anesthesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Perioperative Anxiety
Postoperative Pain
Keywords: Anxiety, Perioperative, Insomnia
Lead sponsor: Dr. Negrin University Hospital
Sponsor class: OTHER
First posted: 2022-10-07
Enrollment: 151
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The randomization of the patients will be carried out by a collaborating researcher through a computer program (Excel 2016) at the time of inclusion in the study. This collaborating researcher will not be able to be present at the surgical intervention and will contact the nursing staff by telephone, indicating which patient should be given music therapy upon arrival in the pre-surgery room.
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

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

Primary outcomes:
measure: Perioperative anxiety
timeFrame: from the arrival to the preanesthesia room to the 4 postoperative hour
Secondary outcomes:
measure: Postoperative pain
timeFrame: From the first postoperative hour to the 4th postoperative hour.
Other outcomes:
Locations:
city: Las Palmas De Gran Canaria
country: Spain
facility: Ángel Becerra
state: Las Palmas
Study officials:
affiliation: Hospital Universitario de Gran Canaria Doctor Negrín
name: Ángel Becerra, PhD
role: PRINCIPAL_INVESTIGATOR
References: