[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658842":3},{"organization":4,"outcomesModule":7,"designInfo":26,"detailedDescription":25,"studyPopulation":25,"armGroups":35,"interventions":51,"overallOfficials":61,"centralContacts":66,"locations":71,"responsibleParty":87,"collaborators":25,"id":90,"slug":91,"hasResults":92,"nctId":93,"briefTitle":94,"officialTitle":95,"acronym":25,"eligibilityCriteria":96,"healthyVolunteers":92,"sex":97,"minAge":98,"maxAge":25,"enrollmentInfo":99,"targetDuration":25,"studyType":102,"phases":103,"briefSummary":105,"conditions":106,"keywords":112,"overallStatus":121,"whyStopped":25,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":123,"startDateStruct":126,"completionDateStruct":128,"leadSponsor":130,"locationsCount":131},{"fullName":5,"class":6},"Ataturk University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":17,"otherOutcomes":25},[9,13],{"measure":10,"description":11,"timeFrame":12},"Preoperative Sleep Quality","Assessed using the Richard-Campbell Sleep Questionnaire (RCSQ). The scale evaluates depth of sleep, falling asleep latency, awakenings, time spent awake, and overall sleep quality (scores range from 0 to 100 mm, where higher scores represent better sleep quality).","Assessed on the morning of surgery (at approximately 07:00 AM, following the preoperative night intervention).",{"measure":14,"description":15,"timeFrame":16},"Preoperative State Anxiety","Assessed using the State-Trait Anxiety Inventory - State Subscale (STAI-S \u002F STAI Form TX-1). The scale consists of 20 items rated on a 4-point Likert scale (1 = Not at all to 4 = Very much so). Total scores range from 20 to 80, with higher scores reflecting greater levels of acute state anxiety.","Assessed at baseline (pre-intervention, preoperative evening around 21:30) and immediately after the 30-minute intervention (preoperative evening around 22:30).",[18,22],{"measure":19,"description":20,"timeFrame":21},"Systolic and Diastolic Blood Pressure","Systolic and diastolic blood pressure measured in millimeters of mercury (mmHg) using a calibrated clinical monitor to evaluate autonomic nervous system responses to auditory interventions.","Baseline (preoperative evening, immediately before intervention at approximately 21:30) and immediately post-intervention (approximately 22:30)",{"measure":23,"description":24,"timeFrame":21},"Heart Rate","Heart rate measured in beats per minute (bpm) using a clinical monitor to evaluate autonomic nervous system responses to auditory interventions.",null,{"allocation":27,"interventionModel":28,"interventionModelDescription":29,"primaryPurpose":30,"observationalModel":25,"timePerspective":25,"maskingInfo":31},"RANDOMIZED","PARALLEL","A prospective, randomized, controlled, parallel-group clinical trial with three arms: White Noise group, Pink Noise group, and Control group (allocation ratio 1:1:1). Eligible participants undergoing elective total knee or hip arthroplasty are stratified by type of surgery (knee vs. hip) and allocated into the three parallel groups using computer-generated block randomization.","SUPPORTIVE_CARE",{"masking":32,"maskingDescription":25,"whoMasked":33},"SINGLE",[34],"OUTCOMES_ASSESSOR",[36,42,47],{"label":37,"type":38,"description":39,"interventionNames":40},"White Noise Group","EXPERIMENTAL","Participants will listen to standardized white noise at 45-50 dB for 30 minutes via over-ear, active noise-cancelling headphones on the preoperative evening (at 10:00 PM) before elective total hip or knee arthroplasty.",[41],"Behavioral: White Noise Intervention",{"label":43,"type":38,"description":44,"interventionNames":45},"Pink Noise Group","Participants will listen to standardized pink noise at 45-50 dB for 30 minutes via over-ear, active noise-cancelling headphones on the preoperative evening (at 10:00 PM) before elective total hip or knee arthroplasty.",[46],"Behavioral: Pink Noise Intervention",{"label":48,"type":49,"description":50,"interventionNames":25},"Control Group","NO_INTERVENTION","Participants will receive standard routine perioperative care and nursing management without any auditory intervention or headphone application.",[52,57],{"type":53,"name":54,"description":55,"armGroupLabels":56,"otherNames":25},"BEHAVIORAL","White Noise Intervention","Participants will listen to standardized white noise played at a volume of 45-50 dB for 30 minutes using over-ear active noise-cancelling headphones on the preoperative night (at approximately 10:00 PM).",[37],{"type":53,"name":58,"description":59,"armGroupLabels":60,"otherNames":25},"Pink Noise Intervention","Participants will listen to standardized pink noise played at a volume of 45-50 dB for 30 minutes using over-ear active noise-cancelling headphones on the preoperative night (at approximately 10:00 PM).",[43],[62],{"name":63,"affiliation":64,"role":65},"Mehmet Günay Uyar, PhD","Erzincan Binali Yildirim Universitesi","PRINCIPAL_INVESTIGATOR",[67],{"name":63,"role":68,"phone":69,"phoneExt":25,"email":70},"CONTACT","05543488391","mehmet.uyar@erzincan.edu.tr",[72],{"facility":73,"status":25,"city":74,"state":75,"zip":76,"country":77,"countryCode":25,"cosmosGeoPoint":78,"geoPoint":83,"contacts":84},"Erzincan Binali Yildirim University Mengucek Gazi Training and Research Hospital","Erzincan","Merkez","24000","Turkey (Türkiye)",{"type":79,"coordinates":80},"Point",[81,82],39.49015,39.73919,{"lat":82,"lon":81},[85],{"name":63,"role":68,"phone":69,"phoneExt":25,"email":86},"mgu38@hotmail.com",{"type":65,"investigatorFullName":88,"investigatorTitle":89,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Mehmet Gunay Uyar","Assistant Professor","100658842","the-effect-of-white-and-pink-noise-in-patients-undergoing-total-hip-and-knee-arthroplasty-100658842",false,"NCT07858058","The Effect of White and Pink Noise in Patients Undergoing Total Hip and Knee Arthroplasty","The Effect of White and Pink Noise on Sleep, Anxiety and Physiological Parameters in Patients Undergoing Total Hip and Knee Arthroplasty: A Randomized Controlled Trial","Inclusion Criteria:\n\n* Scheduled for elective primary unilateral total hip or knee arthroplasty\n* Aged 18 years or older\n* American Society of Anesthesiologists (ASA) physical status classification I, II, or III\n* Literate and able to understand, communicate, and independently complete questionnaires in Turkish\n* Intact hearing ability (no self-reported or diagnosed severe hearing loss)\n* Voluntarily agreed to participate in the study and signed written informed consent\n\nExclusion Criteria:\n\n* Diagnosed psychiatric, cognitive, or neurological disorders that impair communication or scale completion\n* Clinically diagnosed chronic sleep disorders (e.g., severe obstructive sleep apnea, chronic insomnia)\n* Regular use of sedative-hypnotics, anxiolytics, or psychiatric medications within the last month\n* Administration of preoperative sedative or hypnotic premedication on the night before surgery\n* Active ear infection, dermatological lesions, or anatomical deformities preventing the use of over-ear headphones\n* Severe tinnitus, hyperacusis, or hearing aid usage\n* Emergency surgery, bilateral procedures, or revision arthroplasty\n* Known history of substance or alcohol dependence","ALL","18 Years",{"count":100,"type":101},165,"ESTIMATED","INTERVENTIONAL",[104],"NA","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).",[107,108,109,110,111],"Arthroplasty, Replacement, Knee, Hip","Postoperative Nausea and Vomiting","Anxiety","Postoperative Pain After Arthroscopic Knee Surgery","Sleep Quality",[113,114,115,116,117,118,119,120],"Coloured noise","Total knee arthroplasty","Total hip arthroplasty","Sleep quality","Preoperative anxiety","Postoperative pain","Postoperative nausea","Nursing intervention","NOT_YET_RECRUITING","2026-10-02",{"date":124,"type":125},"2026-10-05","ACTUAL",{"date":127,"type":101},"2026-10-10",{"date":129,"type":101},"2027-03-15",{"name":5,"class":6},1]