[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659641":3},{"organization":4,"outcomesModule":7,"designInfo":25,"detailedDescription":31,"studyPopulation":24,"armGroups":32,"interventions":43,"overallOfficials":47,"centralContacts":51,"locations":24,"responsibleParty":59,"collaborators":24,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":66,"acronym":24,"eligibilityCriteria":67,"healthyVolunteers":64,"sex":68,"minAge":69,"maxAge":24,"enrollmentInfo":70,"targetDuration":24,"studyType":73,"phases":74,"briefSummary":76,"conditions":77,"keywords":79,"overallStatus":83,"whyStopped":24,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":24},{"fullName":5,"class":6},"Ataturk University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":20,"otherOutcomes":24},[9,13,16],{"measure":10,"description":11,"timeFrame":12},"Richard-Campbell Sleep Questionnaire","The scale was developed by Richards in 1987. Its validity and reliability in Turkey were established by Özlü and Özer in 2015. The RCUÖ assesses the depth of nighttime sleep, sleep onset latency, frequency of awakenings, duration of wakefulness after waking, sleep quality, and environmental noise levels. It consists of a total of six items. Each item is evaluated using a visual analog scale ranging from 0 to 100. A score of 0-25 indicates \"very poor sleep,\" while a score of 76-100 indicates \"very good sleep.\" As the scale score increases, the patients' sleep quality improves.","Postoperative days 1 and 2",{"measure":14,"description":15,"timeFrame":12},"Quality of Recovery Scale-15","The Turkish validity and reliability study of the scale developed by Stark et al. (2013) was conducted by Kara et al. (2022). A visual analog scale is used within the quality of recovery scale to assess general well-being. The scale consists of 15 items and two sub-dimensions; for each item, the visual analog scale comprises a horizontal line 10 cm in length. Each centimeter represents 1 point, and the score range for each item is 0-10. Scoring is defined as 0 = \"never\" to 10 = \"always\" for positive items, and 0 = \"always\" to 10 = \"never\" for negative items; the total score range for the scale is 0-150. Higher scores indicate better quality of recovery.",{"measure":17,"description":18,"timeFrame":19},"VAS-Patient Satisfaction Scale:","This will be used to determine patients' levels of satisfaction with the care process and the procedure. The scale consists of a 10 cm horizontal line, with the phrase \"Not at all satisfied\" at one end and \"Very satisfied\" at the other. The patient will mark their level of satisfaction regarding the care process on the line. The marked point will indicate the patient's satisfaction score, with a higher score signifying a higher level of satisfaction.","Postoperative days 2",[21],{"measure":22,"description":23,"timeFrame":12},"Total Sleep Duration Measured by [Smartwatch Brand and Model]","Total sleep duration will be assessed using the \\[full brand and model name of the smartwatch\\]. Total sleep duration will be recorded in minutes, representing the total amount of sleep detected by the device during the nighttime sleep period.",null,{"allocation":26,"interventionModel":27,"interventionModelDescription":24,"primaryPurpose":28,"observationalModel":24,"timePerspective":24,"maskingInfo":29},"RANDOMIZED","PARALLEL","SUPPORTIVE_CARE",{"masking":30,"maskingDescription":24,"whoMasked":24},"NONE","Studies indicate that patients must cope with issues such as pain, anxiety, and environmental noise during the postoperative period following surgical interventions. These factors negatively affect patients' sleep, quality of recovery, and satisfaction with care. Although laparoscopic cholecystectomy involves a short hospital stay, sleep problems are frequently observed during the first 24 hours postoperatively due to factors such as shoulder and abdominal pain, nausea, and ward noise. While pharmacological pain control and sleep-regulating agents are used to alleviate insomnia, they are not fully effective on their own due to potential side effects such as respiratory depression, delirium, and nausea\u002Fvomiting; therefore, it is recommended that pharmacological approaches be supplemented with non-pharmacological interventions. Recent studies demonstrate a growing interest in non-pharmacological methods within postoperative care.\n\nNon-pharmacological methods include practices such as taking a warm shower, optimizing the environment for sleep, massage, listening to music, and aromatherapy. One such method is the use of white noise. White noise is a non-pharmacological intervention that creates a more suitable and uninterrupted sleep environment by masking irregular environmental sounds. By providing constant acoustic stimulation, it reduces the perception of environmental noise, facilitates the transition to sleep, supports sleep quality, and can help reduce nighttime awakenings. The literature indicates that white noise suppresses the stress response by increasing parasympathetic activity and contributes to the quality of recovery and patient satisfaction by lowering pain thresholds and anxiety levels. Studies in the literature demonstrate the positive effects of white noise on sleep quality and patient experience across various patient groups. Cho and Hwang (2021) reported that white noise application improved sleep quality in hospitalized patients. Similarly, a 2016 study conducted with individuals aged 65 and older in a coronary intensive care unit found that white noise enhanced sleep quality and patient satisfaction. Positive effects of white noise have also been observed in surgical patient groups. Dai et al. (2026) reported beneficial effects of white noise on sleep in patients following ureteroscopic lithotripsy. Furthermore, a study involving intensive care patients determined that white noise contributed to improvements in sleep duration and sleep efficiency. In a study of patients undergoing lumbar disc herniation surgery, Kızılkaya et al. (2026) noted that white noise increased levels of sleep quality, comfort, and satisfaction. Another study reported that white noise administered during arthroscopic surgery increased patient satisfaction and comfort levels, while also resulting in significant increases in respiratory rate and oxygen saturation, and significant decreases in heart rate and systolic and diastolic blood pressure. Oshvandi et al. (2020) reported that the application of white noise-consisting of sounds such as ocean waves, rivers, and rain-reduced sleep disturbances and increased patient comfort in patients monitored in the intensive care unit following open-heart surgery.\n\nThese findings indicate that white noise is a safe and feasible method capable of supporting sleep quality, enhancing patient comfort, and contributing to satisfaction with care across various clinical settings. A review of the literature reveals that while most studies on white noise application have focused on newborns and intensive care patients, research regarding its use in the postoperative period remains limited. In particular, the scarcity of studies simultaneously evaluating the effects of white noise on sleep quality, recovery quality, and patient satisfaction-specifically in patients undergoing laparoscopic cholecystectomy-underscores the necessity of this research.\n\nIn this context, it is anticipated that the application of white noise could serve as an effective, innovative, and easily implementable nursing intervention to improve sleep and recovery quality among surgical patients. Although the literature contains numerous studies on the use of white noise in neonatal intensive care units and with pediatric patients, there is a notable gap regarding its application as a specific intervention for surgical patient populations. By addressing this gap, the proposed randomized controlled trial will contribute to the development of evidence-based, non-pharmacological nursing practices applicable during the postoperative period. The findings are expected to provide a scientific basis for clinical practices aimed at enhancing patient safety and sleep quality, as well as improving the overall quality of care.",[33,37],{"label":34,"type":35,"description":36,"interventionNames":24},"Control Group","NO_INTERVENTION","Participants will receive routine postoperative care without white noise",{"label":38,"type":39,"description":40,"interventionNames":41},"White Noise","EXPERIMENTAL","Participants will receive white noise in addition to routine postoperative care",[42],"Other: White Noise",[44],{"type":6,"name":38,"description":45,"armGroupLabels":46,"otherNames":24},"Patients in the white noise group will receive white noise in addition to routine nursing care. The intervention will be administered in the patient's room in a manner that does not disturb them. Patients will listen to white noise (sounds of rain and waterfalls) via Bluetooth headphones for 30 minutes before bedtime on the evening of postoperative days 0 and 1. Following the white noise intervention, sleep monitoring will be initiated using a smartwatch worn by the patient. Data obtained from the smartwatch will be recorded on the mornings of postoperative days 1 and 2. Subsequently, the Richard-Campbell Sleep Questionnaire and the Quality of Recovery Scale will be completed on the mornings of postoperative days 1 and 2, following morning treatment. A satisfaction scale will be administered on postoperative day 2 to assess the level of satisfaction with the intervention.",[38],[48],{"name":49,"affiliation":5,"role":50},"TÜLAY KILINÇ, PhD","PRINCIPAL_INVESTIGATOR",[52,57],{"name":53,"role":54,"phone":55,"phoneExt":24,"email":56},"Tülay KILINÇ, PhD","CONTACT","05376592051","tlyhmsre@hotmail.com",{"name":53,"role":54,"phone":55,"phoneExt":24,"email":58},"ayseguul21@hotmail.com",{"type":50,"investigatorFullName":60,"investigatorTitle":61,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"Tülay KILINÇ","Assistant Professor","100659641","the-effect-of-white-noise-on-sleep-quality-of-recovery-and-satisfaction-in-patients-undergoing-laparoscopic-cholecystectomy-100659641",false,"NCT07867613","The Effect of White Noise on Sleep, Quality of Recovery, and Satisfaction in Patients Undergoing Laparoscopic Cholecystectomy","Inclusion Criteria:\n\n* Being 18 years of age or older,Undergoing laparoscopic cholecystectomy,\n* Being conscious, oriented, and cooperative,\n* Having no hearing impairment,\n* Having no condition that would prevent listening to white noise,\n* Having no physical condition that would prevent the use of a smartwatch,\n* Being in a stable general condition,\n* Volunteering to participate in the study.\n* Having no diagnosed psychiatric, neurological, or cognitive disorder.\n* Having no diagnosed sleep disorder and not regularly using sleep medication\n\nExclusion Criteria:\n\n* Conversion from laparoscopic surgery to open surgery,\n* Developing a serious postoperative complication,","ALL","18 Years",{"count":71,"type":72},64,"ESTIMATED","INTERVENTIONAL",[75],"NA","This randomized controlled trial aims to evaluate the effect of white noise on sleep, recovery quality, and satisfaction in patients undergoing laparoscopic cholecystectomy. In the postoperative period, patients encounter numerous physical and psychological stressors, such as pain, difficulty adapting to the hospital environment, immobilization, environmental noise, frequent nursing interventions, individual characteristics, and illness-related anxieties. These factors disrupt sleep patterns; a decline in sleep quality can negatively affect tissue healing, immune function, pain control, psychological well-being, and the overall recovery process. Consequently, patient satisfaction with the care process may also decrease. Although pharmacological methods are commonly used to manage postoperative insomnia, they are not always sufficiently effective and carry various limitations, such as sedation, drug interactions, and other adverse effects. Therefore, interest has grown in recent years regarding non-pharmacological interventions that are safe, cost-effective, easy to implement, and carry a low risk of side effects. White noise, one such intervention, can create a more favorable sleep environment by masking irregular environmental sounds, promote relaxation, and has the potential to improve sleep quality.",[78],"Laparoscopic Cholecystectomy",[38,80,81,82,78],"Sleep Quality","Quality of Recovery","Patient Satisfaction","NOT_YET_RECRUITING","2026-10-07",{"date":86,"type":87},"2026-10-09","ACTUAL",{"date":89,"type":72},"2026-10-01",{"date":91,"type":72},"2027-08-01",{"name":5,"class":6}]