Perioperative Effect of Music in Patients Undergoing General Anesthesia

Postoperative Pain Clinical Trial

— EMBAG  

Official title:

Perioperative Effect of Music in Patients Undergoing General Anesthesia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05572437
• Other study ID #: 2020-370-1
• Status: Recruiting
• Phase: N/A
• Start date: October 15, 2022
• Est. completion date: April 30, 2024

Study information

• Verified date: February 2024
• Source: Dr. Negrin University Hospital
• Contact: Ángel Becerra, PhD
• Phone: +34676229025
• Email: angbecbol[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: April 30, 2024
• Est. primary completion date: March 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative
• Perioperative Anxiety
• Postoperative Pain

Intervention

Device:
• Music Therapy
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-anesthesia room, during surgery and in the PACU.

Locations

Country	Name	City	State
Spain	Ángel Becerra	Las Palmas De Gran Canaria	Las Palmas

Sponsors (1)

Lead Sponsor	Collaborator
Dr. Negrin University Hospital

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Perioperative anxiety	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.	from the arrival to the preanesthesia room to the 4 postoperative hour
Secondary	Postoperative pain	Postoperative pain will be assessed using the visual analog scale in the immediate postoperative period.	From the first postoperative hour to the 4th postoperative hour.