Binaural-beat music during knee replacement with spinal anesthesia
Effect of Binaural Beat Music Played During Knee Arthroplasty With Spinal Anesthesia on Anxiety, Pain and Cortisol Levels.
This study will test whether listening to binaural beat music during knee replacement under spinal anesthesia reduces anxiety, pain, and cortisol levels in adults.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Nuh Naci Yazgan University Academic / other |
| Locations | 1 site (Kocasinan, Kayseri) |
| Trial ID | NCT06729294 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults older than 18 undergoing a first-time unilateral knee arthroplasty under spinal anesthesia (ASA 1–3), who can communicate and have no neurological or psychiatric diagnoses, are ideal candidates.
Not a fit: Patients with hearing impairment, those receiving or converted to general anesthesia, those who develop complications or require ICU transfer, or those with relevant neurological/psychiatric conditions are unlikely to benefit.
Why it matters
Potential benefit: If successful, the approach could reduce perioperative anxiety and pain and lower stress hormone responses, potentially improving comfort and recovery.
How similar studies have performed: Previous studies of music interventions and some binaural-beat research have reported mixed but occasionally positive effects on perioperative anxiety and pain, so the approach has some supportive but not definitive evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Kocasinan, Kayseri
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.