- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06764407
The Effect of Music on Postoperative Anxiety
May 27, 2025 updated by: Burak NALBANT, Ankara City Hospital Bilkent
The Effect of Patient Preferred Music on Postoperative Anxiety
In this study, it is planned to learned the effect of listening to the music preferred by the patient on postoperative anxiety.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Preoperative anxiety can be detected via structured and standardized screening by the State-Trait Anxiety Inventory (STAI) I and II.
80 patients scheduled for total knee arthroplasty surgery for 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 two groups as listening patient preferential music, and control.
The patient favorite music track and singer without limiting the kind of music or classical music will be played through the headphones.Secondary aim is to assess the effect of listening patient preferred music on Quality of recovery, postoperative pain, MCID (minimal clinically important diffirence), patient and surgeon satisfaction.
Study Type
Interventional
Enrollment (Actual)
80
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Ankara, Turkey
- Ankara City Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Undergo Total Knee Arthroplasty Under Spinal Anesthesia
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
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.
|
Patients will listen to their preferred music through the headphones before surgery and intraoperative period.
|
|
Placebo Comparator: No Music
Patients will not listen to 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
Time Frame: Preoperative 1st hour and Postoperative 4th hour
|
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.
|
Preoperative 1st hour and Postoperative 4th hour
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Numerical Rating Scale (NRS)
Time Frame: Postoperative 4th, 12th and 24th hours
|
11-point numerical rating scale for pain (0='no pain' and 10='worst pain possible pain') were explained.
|
Postoperative 4th, 12th and 24th hours
|
|
The quality of postoperative functional recovery (QoR-15) score
Time Frame: Preoperative 1st hour and Postoperative 24th hour
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The patient-reported Turkish QoR-15 score includes 15 questions that evaluate the patient's postoperative recovery.
The QoR-15 score is grouped under two groups, A and B. A high QoR-15 score, a score between 0 (poor) and 10 (excellent) for each item, and a total score of 150 indicate better quality of recovery.
|
Preoperative 1st hour and Postoperative 24th hour
|
|
Patient satisfaction score
Time Frame: Postoperative 24th hour
|
Patients were asked about their satisfaction levels with a number between 0-10.
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Postoperative 24th hour
|
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MCID of STAI score
Time Frame: 24 hour
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Calculation of the MCID of the STAI score
|
24 hour
|
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MCID of QoR-15 score
Time Frame: 24 hour
|
Calculation of the MCID of the QoR-15 score
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24 hour
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Bradt J, Dileo C, Shim M. Music interventions for preoperative anxiety. Cochrane Database Syst Rev. 2013 Jun 6;2013(6):CD006908. doi: 10.1002/14651858.CD006908.pub2.
- Kavak Akelma F, Altinsoy S, Arslan MT, Ergil J. Effect of favorite music on postoperative anxiety and pain. Anaesthesist. 2020 Mar;69(3):198-204. doi: 10.1007/s00101-020-00731-8. Epub 2020 Feb 11.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 9, 2025
Primary Completion (Actual)
March 3, 2025
Study Completion (Actual)
April 1, 2025
Study Registration Dates
First Submitted
January 2, 2025
First Submitted That Met QC Criteria
January 2, 2025
First Posted (Actual)
January 8, 2025
Study Record Updates
Last Update Posted (Actual)
May 28, 2025
Last Update Submitted That Met QC Criteria
May 27, 2025
Last Verified
May 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 33
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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