The Effect of Music on Postoperative Anxiety

Comparison of the Effect of Patient Preferred Music on Postoperative Anxiety

In this study, it is planned to compare the effect of listening to the music preferred by the patient and classical music on postoperative anxiety.

Study Overview

• Status: Completed
• Conditions: Anxiety Postoperative
• Intervention / Treatment: Other: Patient preferential music; Other: Classical music; Other: No music

Detailed Description

Preoperative anxiety can be detected via structured and standardized screening by the State-Trait Anxiety Inventory (STAI) I and II. 225 patients scheduled for inguinal hernia surgery for any reason in the age range of 18-70 will be included in our study. Preoperative STAI I and II score (anxiety questionnaire) will be applied to each patient. The patients will be divided into three groups as preoperative patient preferential music, classical music and not played. The patient favorite music track and singer without limiting the kind of music or classical music will be played through the headphones. The STAI will be repeated at postoperative, the Numeric Rating Scale (NRS) and patient satisfaction will be measured at postoperative.

• Study Type: Interventional
• Enrollment (Actual): 225
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Gölbaşı
    • Ankara, Gölbaşı, Turkey, 06100
      • Dışkapı Yıldırım Beyazıt training and research hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Undergo inguinal hernia surgery under general anesthesia,
• Being the ability to speak, read and write the Turkish language

Exclusion Criteria:

• Poor vision
• Significant hearing loss
• Dementia
• Active opioid use
• Regular use of anxiolytics or discontinuation of them on the day of surgery
• Unwillingness to participate in the study
• Unwillingness to listening to music

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Patient preferential music; The preference of the patients will be listened to preoperatively through the headphones.	Other: Patient preferential music; Patients will listen to their preferred music through the headphones before surgery.
Active Comparator: Classical music; Classical music (Four Seasons from Vivaldi) will be listened to preoperatively through the headphones.	Other: Classical music; Patients will listen to classical music through headphones before surgery.
Placebo Comparator: No music; the patients will not listen.	Other: No music; Patients will not listen to music.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Spielberg State-Trait Anxiety Inventory (STAI) score	The test scores between 20 and 80, with higher scores indicating more generalized and stronger anxiety. Preoperative and postoperative STAI I score questions will be asked.	4 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Numerical Rating Scale (NRS)	11-point numerical rating scale for pain (0='no pain' and 10='worst pain possible pain') were explained.	24 hours
The quality of postoperative functional recovery (QoR-40) score	The quality of postoperative functional recovery will assess using the QoR-40, which assesses physical comfort (12 items), emotional state (9 items), physical independence (5 items), psychological support (7 items), and pain (7 items). Each item is rated on a 5-point Likert scale: none of the time, some of the time, usually, most of the time, and all the time. The total score ranges from 40 (poorest quality of recovery) to 200 (the best quality of recovery). The QoR-40 will administer one day before surgery in outpatient clinics of anesthesiology, and before discharge from hospital on the first postoperative day.	24 hours
Patient satisfaction score	Patient satisfaction will assess prior to discharge using a Likert scale type (range, 1 to 7) verbally administered questionnaire	24 hours

Collaborators and Investigators

• Sponsor: Ankara Diskapi Training and Research Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2021
• Primary Completion (Actual): July 1, 2022
• Study Completion (Actual): October 1, 2022

Study Registration Dates

• First Submitted: February 18, 2020
• First Submitted That Met QC Criteria: February 18, 2020
• First Posted (Actual): February 20, 2020

Study Record Updates

• Last Update Posted (Actual): May 19, 2023
• Last Update Submitted That Met QC Criteria: May 18, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: Classical music; Patient preferential music; Postoperative anxiety
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: Music

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No