- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06905899
Effect of Audio Book applıcatıon on patıents Blood Pressure, Pulse Rate and anxıety Levels Before Total Knee Replacement Surgery
April 29, 2026 updated by: Beyza Yilmaz
Before the TDP surgery, the anxiety levels of the patients in the experimental group will be measured by listening to an audio book.
Study Overview
Detailed Description
Before Total Knee Prosthesis surgery, patients will have their blood pressure, pulse and anxiety levels measured before the surgery.
Patients in the experimental group will listen to an audiobook for 20 minutes.
The selected book will be played via wireless headphones.
The researcher will check the battery level of the headphones and charge it when necessary.
In this way, the headphones will be ready for the next patient.
A smartphone with Spotify mobile application installed, which the researcher is a member of, will be used for the audiobook application.
The connection between the headphones and the audiobook will be provided via Bluetooth.
The patient will be present from the moment they start listening to the audiobook section, and if they experience any hearing problems or if there is an attempt to stop listening, immediate intervention will be made.
Necessary interventions will be made for patients who experience interruptions during listening to listen again.
After each application, the headphones will be cleaned with an antiseptic solution containing chlorhexidine 2%.
The patient will be asked to rest for 10 minutes after the audiobook application.
At the end of 10 minutes, the patient will be filled with an AÖKÖ and the patient's blood pressure and pulse will be measured and recorded.
When measuring patients' blood pressure, the same blood pressure monitor with calibrated cuff, manometer, and stethoscope will be used, and when measuring pulse, the saturation device data will be used and recorded.
Study Type
Interventional
Enrollment (Estimated)
93
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 Contact
- Name: Beyza yılmaz
- Phone Number: 5457736979 +905457736979
- Email: byzaymz40@gmail.com
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
- Child
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Must be between 40-80 years of age,
- Patients must be conscious and able to communicate,
- Individuals who volunteer to participate in the study,
- No hearing problems,
- Individuals who will undergo TKA surgery,
- Can understand Turkish,
- Patients must have elective (planned) surgery (must have been hospitalized at least 2 hours before surgery).
Exclusion Criteria:
- Refusing to participate in the study,
- Any communication barrier,
- Cancellation of TKA surgery for any reason.
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: Supportive Care
- Allocation: N/A
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Effect of preoperative audiobook application on blood pressure, pulse and anxiety levels of patients
Patients in the experimental group will listen to an audio book for 20 minutes.
|
audio book listening
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The Surgery Specific Anxiety Scale will be used for preoperative anxiety.
Time Frame: up to 12 months
|
It was developed to determine the level of anxiety in surgical patients during and after surgery.
The scale is a 5-point Likert-type scale consisting of 10 questions designed to measure the anxiety that patients may experience regarding surgery.
The surgery-specific anxiety score in the scale is obtained by adding the responses to all items, and the total score of the scale is 50.
As the score increases, the level of anxiety experienced also increases.
|
up to 12 months
|
|
Patient Introduction Form
Time Frame: up to 12 months
|
It consists of two parts.
The first part includes introductory information such as the patient's age, gender, education level, and employment status, while the second part evaluates the total knee prosthesis surgery history, current chronic disease status, and knowledge about the audiobook.
There will be a total of 10 questions in the form.
|
up to 12 months
|
|
Patient Pulse Form,
Time Frame: up to 12 months
|
Pulse findings of patients who will undergo total knee replacement surgery will be recorded before and after the audiobook application.
|
up to 12 months
|
|
patient blood pressure form
Time Frame: up to 12 months
|
Blood pressure findings of patients who will undergo total knee prosthesissurgery will be recorded before and after the audiobook application and it will be checked whether it is effective in reducing the blood pressure.
|
up to 12 months
|
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.
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 (Estimated)
June 30, 2026
Primary Completion (Estimated)
July 25, 2026
Study Completion (Estimated)
August 30, 2026
Study Registration Dates
First Submitted
February 19, 2025
First Submitted That Met QC Criteria
March 24, 2025
First Posted (Actual)
April 2, 2025
Study Record Updates
Last Update Posted (Actual)
May 5, 2026
Last Update Submitted That Met QC Criteria
April 29, 2026
Last Verified
April 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AhiEvranUERHseslikitap1487
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
ı don't know
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
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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