The Effect of Music on Postoperative Anxiety

Sponsor
Ankara Diskapi Training and Research Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT04277559
Collaborator
(none)
225
1
3
11.6
19.4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Patient preferential music
  • Other: Classical music
  • Other: No music
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
225 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Other
Official Title:
Comparison of the Effect of Patient Preferred Music on Postoperative Anxiety
Actual Study Start Date :
Feb 1, 2021
Actual Primary Completion Date :
Nov 1, 2021
Anticipated Study Completion Date :
Jan 20, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. 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

  1. Numerical Rating Scale (NRS) [24 hours]

    11-point numerical rating scale for pain (0='no pain' and 10='worst pain possible pain') were explained.

  2. 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.

  3. Patient satisfaction score [24 hours]

    Patient satisfaction will assess prior to discharge using a Likert scale type (range, 1 to 7) verbally administered questionnaire

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Dışkapı Yıldırım Beyazıt Training and Research Hospital Ankara Gölbaşı Turkey 06100

Sponsors and Collaborators

  • Ankara Diskapi Training and Research Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Fatma Kavak Akelma, anesthesiology and reanimation specialist doctor, Ankara Diskapi Training and Research Hospital
ClinicalTrials.gov Identifier:
NCT04277559
Other Study ID Numbers:
  • music
First Posted:
Feb 20, 2020
Last Update Posted:
Jan 14, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Fatma Kavak Akelma, anesthesiology and reanimation specialist doctor, Ankara Diskapi Training and Research Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 14, 2022