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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04277559
Other study ID # music
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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