Perioperative Effect of Music in Patients Undergoing General Anesthesia

NCT05572437 | Completed

• 1 other identifier: 2020-370-1
• Study Type: interventional
• Target: 151
• Locations: 1 country
• Sites: 1

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.

Conditions

Perioperative Anxiety; Postoperative Pain

Keywords

Anxiety, Perioperative, Insomnia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Postoperative pain

  From the first postoperative hour to the 4th postoperative hour.

Study Arms (2)

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.

Device: Music Therapy

Interventions

Music Therapy 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.

Intervention Group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Dr. Negrin University Hospital: lead

Study Sites (1)

Ángel Becerra

Las Palmas de Gran Canaria, Las Palmas, 35019, Spain

Location

MeSH Terms

Conditions

Pain, Postoperative; Anxiety Disorders; Sleep Initiation and Maintenance Disorders

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Mental Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Sensory Art Therapies; Complementary Therapies; Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Ángel Becerra, PhD

  Hospital Universitario de Gran Canaria Doctor Negrín

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: October 5, 2022
• First Posted: October 7, 2022
• Study Start: October 15, 2022
• Primary Completion: March 30, 2024
• Study Completion: April 30, 2024
• Last Updated: August 7, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)