The Effect of Music on Postoperative Anxiety

Anxiety Postoperative Clinical Trial

Official title:

Comparison of the Effect of Patient Preferred Music on Postoperative Anxiety

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04277559
• Other study ID #: music
• Status: Completed
• Phase: N/A
• Start date: November 1, 2021
• Est. completion date: October 1, 2022

Study information

• Verified date: January 2023
• Source: Ankara Diskapi Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 225
• Est. completion date: October 1, 2022
• Est. primary completion date: July 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety Disorders
• Anxiety Postoperative

Intervention

Other:
• Patient preferential music
Patients will listen to their preferred music through the headphones before surgery.
• Classical music
Patients will listen to classical music through headphones before surgery.
• No music
Patients will not listen to music.

Locations

Country	Name	City	State
Turkey	Diskapi Yildirim Beyazit Training and Research Hospital	Ankara	Gölbasi

Sponsors (1)

Lead Sponsor	Collaborator
Ankara Diskapi Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Numerical Rating Scale (NRS)	11-point numerical rating scale for pain (0='no pain' and 10='worst pain possible pain') were explained.	24 hours
Secondary	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
Secondary	Patient satisfaction score	Patient satisfaction will assess prior to discharge using a Likert scale type (range, 1 to 7) verbally administered questionnaire	24 hours