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Not yet recruiting NCT06905899

Effect of Audio Book applıcatıon on patıents Blood Pressure, Pulse Rate and anxıety Levels Before Total Knee Replacement Surgery

No phase Interventional Stress

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: audiobook app.
Who it may be relevant to
Registry conditions: Stress. Basic parameters: 40 months — 80 months · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • Other audiobook app
    audio book listening

Primary outcome measures

  • The Surgery Specific Anxiety Scale will be used for preoperative anxiety. [Time frame: up to 12 months]
  • Patient Introduction Form [Time frame: up to 12 months]
  • Patient Pulse Form, [Time frame: up to 12 months]
  • patient blood pressure form [Time frame: up to 12 months]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Sequential
Masking
Open label
Primary purpose
Supportive care

Study locations

Center list to be confirmed — check the primary protocol.

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. PMID 32146074

Identifiers

NCT: NCT06905899 · AhiEvranUERHseslikitap1487

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗