NCT06905899

Brief Summary

Before the TDP surgery, the anxiety levels of the patients in the experimental group will be measured by listening to an audio book.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
93

participants targeted

Target at P50-P75 for not_applicable

Timeline
2mo left

Started Jun 2026

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 19, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 2, 2025

Completed
1.2 years until next milestone

Study Start

First participant enrolled

June 30, 2026

Expected
25 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 25, 2026

1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2026

Last Updated

May 5, 2026

Status Verified

April 1, 2026

Enrollment Period

25 days

First QC Date

February 19, 2025

Last Update Submit

April 29, 2026

Conditions

Keywords

anxietyblood pressurebefore surgerytotal knee prosthesisaudio book

Outcome Measures

Primary Outcomes (4)

  • The Surgery Specific Anxiety Scale will be used for preoperative anxiety.

    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

    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,

    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

    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

Study Arms (1)

Effect of preoperative audiobook application on blood pressure, pulse and anxiety levels of patients

EXPERIMENTAL

Patients in the experimental group will listen to an audio book for 20 minutes.

Other: audiobook app

Interventions

audio book listening

Effect of preoperative audiobook application on blood pressure, pulse and anxiety levels of patients

Eligibility Criteria

Age40 Months - 80 Months
Sexall(Gender-based eligibility)
Gender Eligibility DetailsThe patients in the experimental and control groups consisted of male and female patients.
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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).

You may not qualify if:

  • Refusing to participate in the study,
  • Any communication barrier,
  • Cancellation of TKA surgery for any reason.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Sahin G, Basak T. The Effects of Intraoperative Progressive Muscle Relaxation and Virtual Reality Application on Anxiety, Vital Signs, and Satisfaction: A Randomized Controlled Trial. J Perianesth Nurs. 2020 Jun;35(3):269-276. doi: 10.1016/j.jopan.2019.11.002. Epub 2020 Mar 4.

    PMID: 32146074BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
The researcher applied forms and audio books to the experimental and control groups and evaluated the results.
Purpose
SUPPORTIVE CARE
Intervention Model
SEQUENTIAL
Model Details: The study will be conducted for 2 groups as experimental and control groups.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

February 19, 2025

First Posted

April 2, 2025

Study Start (Estimated)

June 30, 2026

Primary Completion (Estimated)

July 25, 2026

Study Completion (Estimated)

August 30, 2026

Last Updated

May 5, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

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