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NCT07858058
The Effect of White and Pink Noise in Patients Undergoing Total Hip and Knee Arthroplasty
Conditions: Arthroplasty, Replacement, Knee, Hip, Postoperative Nausea and Vomiting, Anxiety, Postoperative Pain After Arthroscopic Knee Surgery, Sleep Quality
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 165
Sponsor: Ataturk University
Location: Erzincan Binali Yildirim University Mengucek Gazi Training and Research Hospital Erzincan Merkez
Summary
This study aims to investigate the effects of preoperative white noise and pink noise interventions on sleep quality, anxiety, postoperative pain, nausea, and physiological parameters in patients undergoing elective total hip arthroplasty (THA) or total knee arthroplasty (TKA). A total of 165 adult patients will be randomly allocated into three equal groups: a white noise group, a pink noise group, and a control group (55 participants per group). On the evening prior to surgery (around 10:00 PM), participants in the experimental groups will listen to standardized white noise or pink noise at 45-50 dB for 30 minutes via over-ear, active noise-cancelling headphones. Participants in the control group will receive routine perioperative care without any auditory intervention. Data regarding sleep quality, anxiety levels, pain intensity, nausea, and hemodynamics (blood pressure, heart rate, respiratory rate, and oxygen saturation) will be collected using validated scales and physiological monitoring before and after the intervention as well as in the postoperative period (at 0, 12, and 24 hours).
Eligibility Criteria
Inclusion Criteria:
* Scheduled for elective primary unilateral total hip or knee arthroplasty
* Aged 18 years or older
* American Society of Anesthesiologists (ASA) physical status classification I, II, or III
* Literate and able to understand, communicate, and independently complete questionnaires in Turkish
* Intact hearing ability (no self-reported or diagnosed severe hearing loss)
* Voluntarily agreed to participate in the study and signed written informed consent
Exclusion Criteria:
* Diagnosed psychiatric, cognitive, or neurological disorders that impair communication or scale completion
* Clinically diagnosed chronic sleep disorders (e.g., severe obstructive sleep apnea, chronic insomnia)
* Regular use of sedative-hypnotics, anxiolytics, or psychiatric medications within the last month
* Administration of preoperative sedative or hypnotic premedication on the night before surgery
* Active ear infection, dermatological lesions, or anatomical deformities preventing the use of over-ear headphones
* Severe tinnitus, hyperacusis, or hearing aid usage
* Emergency surgery, bilateral procedures, or revision arthroplasty
* Known history of substance or alcohol dependence
Source: ClinicalTrials.gov (NCT07858058). StuddyBuddy aggregates publicly available trial information.