The Effect of Music on Postoperative Anxiety

Not Applicable

Completed

• Conditions: Anxiety Postoperative

• Registration Number: NCT04277559
• Lead Sponsor: Ankara Diskapi Training and Research Hospital

Brief Summary

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.

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 Timeline

• Study First Submitted: 2020-02-18
• Study First Submitted QC: 2020-02-18
• Study First Posted: 2020-02-20
• Study Start: 2021-11-01
• Primary Completion: 2022-07-01
• Study Completion: 2022-10-01
• Status Verified: 2023-01
• Last Update Submitted: 2023-05-18
• Last Update Posted: 2023-05-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 225

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Spielberg State-Trait Anxiety Inventory (STAI) score	4 hours	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.

Secondary Outcome Measures

Name	Time	Method
Numerical Rating Scale (NRS)	24 hours	11-point numerical rating scale for pain (0='no pain' and 10='worst pain possible pain') were explained.
The quality of postoperative functional recovery (QoR-40) score	24 hours	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.
Patient satisfaction score	24 hours	Patient satisfaction will assess prior to discharge using a Likert scale type (range, 1 to 7) verbally administered questionnaire

Trial Locations

Locations (1)

Dışkapı Yıldırım Beyazıt Training and Research Hospital; 🇹🇷 Ankara, Gölbaşı, Turkey