StressNCT06905899
Effect of Audio Book applıcatıon on patıents Blood Pressure, Pulse Rate and anxıety Levels Before Total Knee Replacement Surgery
A study testing audiobook app in people with Stress, run by Beyza Yilmaz.
Trial summary
Before the TDP surgery, the anxiety levels of the patients in the experimental group will be measured by listening to an audio book. Read more about this study
- Who is it for?
- Ages 40 to 80 monthsHealthy volunteers can take part
- Conditions the study is for
- Stress
- What is being tested?
- audiobook app
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 93 participants
- Where
- No sites listed yet
- Study dates
- 30 Jun 2026to 30 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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).
Who cannot join
- Refusing to participate in the study,
- Any communication barrier,
- Cancellation of TKA surgery for any reason.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Before the TDP surgery, the anxiety levels of the patients in the experimental group will be measured by listening to an audio book.
Read the 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.
- Conditions
- Stress
- Being tested
- audiobook app
- Keywords
- anxiety, blood pressure, before surgery, total knee prosthesis, audio book
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
audiobook appOther
audio book listening
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: audiobook app |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2025
- Study start30 Jun 2026 (estimated)
- Primary completion25 Jul 2026 (estimated)
- Study completion30 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- The study will be conducted for 2 groups as experimental and control groups.
- Masking
- None (open label)
- Enrolment
- 93 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beyza Yilmaz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Beyza Yilmaz, Ahi Evran University Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06905899
- Sponsor's protocol ID
- AhiEvranUERHseslikitap1487
- Status last verified
- Apr 2026
- First submitted
- 19 Feb 2025
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: ı don't know
Publications
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.
PubMed 32146074
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Audio Book applıcatıon on patıents Blood Pressure, Pulse Rate and anxıety Levels Before Total Knee Replacement Surgery
- ClinicalTrials.gov ID
- NCT06905899
- Acronym / sponsor ID
- AhiEvranUERHseslikitap1487
- Conditions
- Stress
- Keywords
- anxiety, blood pressure, before surgery, total knee prosthesis, audio book
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 93 participants (estimated)
- Lead sponsor
- Beyza YilmazUniversity, hospital or other
- Study start
- 30 Jun 2026 (estimated)
- Primary completion
- 25 Jul 2026 (estimated)
- Study completion
- 30 Aug 2026 (estimated)
- First posted
- 2 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Before the TDP surgery, the anxiety levels of the patients in the experimental group will be measured by listening to an audio book.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The study will be conducted for 2 groups as experimental and control groups.
| Arm | Type | Receives |
|---|---|---|
| Effect of preoperative audiobook application on blood pressure, pulse and anxiety levels of patients | Experimental | Other: audiobook appPatients in the experimental group will listen to an audio book for 20 minutes. |
Who may qualify
- Ages
- 40 to 80 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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,
Key exclusion criteria (3 listed)
- Refusing to participate in the study,
- Any communication barrier,
- Cancellation of TKA surgery for any reason.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| audiobook appaudio book listening | Other | Effect of preoperative audiobook application on blood pressure, pulse and anxiety levels of patients |
Primary outcome
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.
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- Background: PubMed 32146074Sahin 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.
- Individual participant dataSharing planned: No. ı don't know
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing audiobook app in people with Stress, run by Beyza Yilmaz.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Beyza yılmaz (+905457736979 ext. 5457736979, byzaymz40@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Surgery Specific Anxiety Scale will be used for preoperative anxiety. (time frame: up to 12 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06905899, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026.