Binaural-beat music during knee replacement with spinal anesthesia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized controlled experimental study comparing binaural beat music played during spinal anesthesia to a control condition in patients having unilateral knee arthroplasty. Forty adults will be randomized (20 music, 20 control) and measures of anxiety, pain scores, and salivary or serum cortisol will be taken around the procedure. Eligible participants are first-time unilateral knee replacement patients ASA I–III who can communicate and have no neurological or psychiatric diagnosis, and procedures are scheduled as first cases of the day. The intervention is noninvasive music playback during the operation, with standard perioperative care otherwise unchanged.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Patients who are older than 18 years,
* Who have undergone unilateral knee arthroplasty under spinal anesthesia for the first time,
* Who can communicate verbally,
* Who are in the ASA 1-2-3 group,
* Who do not have a neurological or psychiatric diagnosis will be included in the study.
* Since cortisol levels will be measured in our study, the first cases of the day will be included in the study.

Exclusion Criteria:

* Patients who refused to participate in the study were those with hearing impairment due to age or disease,
* Those who had any contraindications for spinal anesthesia,
* Those who were transferred to intensive care after the procedure,
* Those who developed complications during and after the procedure,
* Those who underwent general anesthesia,
* Those whose type of anesthesia was changed during surgery.

Where it's running

• Kayseri City Hospital
  Kocasinan, Kayseri, Turkey (Türkiye) Recruiting

Study contacts

• Principal investigator: Fadime Ertural — Nuh Naci Yazgan Üniversity
• Study coordinator: Fadime Ertural
• Email: fertural@nny.edu.tr
• Phone: +905535904409

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.