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

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
93

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Other: audiobook app
audio book listening

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Beyza Yilmaz

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

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 30, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 25, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 30, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 19, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 24, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 2, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 5, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 29, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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