Perioperative Effect of Music in Patients Undergoing General Anesthesia

NCT ID: NCT05572437

Last Updated: 2024-08-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 151 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-15
• Study Completion Date: 2024-04-30

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.

Conditions

Perioperative Anxiety; Postoperative Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Control Group

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Intervention Group

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.

Group Type: EXPERIMENTAL

Music Therapy

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dr. Negrin University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Ángel Becerra

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ángel Becerra, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario de Gran Canaria Doctor Negrín

Locations

Ángel Becerra

Las Palmas de Gran Canaria, Las Palmas, Spain

Countries

Spain

Other Identifiers

2020-370-1

Identifier Type: -

Identifier Source: org_study_id