The Effect of White Noise on Sleep, Quality of Recovery, and Satisfaction in Patients Undergoing Laparoscopic Cholecystectomy

NCT07867613 | Not Yet Recruiting

• 1 other identifier: tulay27
• Study Type: interventional
• Target: 64
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Laparoscopic Cholecystectomy

Keywords

White Noise; Sleep Quality; Quality of Recovery; Patient Satisfaction; Laparoscopic Cholecystectomy

Outcome Measures

Primary Outcomes (3)

• 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

• 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.

  Postoperative days 1 and 2

• 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

Secondary Outcomes (1)

• Total Sleep Duration Measured by [Smartwatch Brand and Model]

  Postoperative days 1 and 2

Study Arms (2)

Control Group

NO INTERVENTION

Participants will receive routine postoperative care without white noise

White Noise

EXPERIMENTAL

Participants will receive white noise in addition to routine postoperative care

Other: White Noise

Interventions

White Noise OTHER

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.

White Noise

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Being 18 years of age or older,Undergoing laparoscopic cholecystectomy,
• Being conscious, oriented, and cooperative,
• Having no hearing impairment,
• Having no condition that would prevent listening to white noise,
• Having no physical condition that would prevent the use of a smartwatch,
• Being in a stable general condition,
• Volunteering to participate in the study.
• Having no diagnosed psychiatric, neurological, or cognitive disorder.
• Having no diagnosed sleep disorder and not regularly using sleep medication

You may not qualify if:

• Conversion from laparoscopic surgery to open surgery,
• Developing a serious postoperative complication,

Sponsors & Collaborators

• Ataturk University: lead

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Patient Satisfaction

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• TÜLAY KILINÇ, PhD

  Ataturk University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tülay KILINÇ, PhD

CONTACT

05376592051; tlyhmsre@hotmail.com

Tülay KILINÇ, PhD

CONTACT

05376592051; ayseguul21@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: September 18, 2026
• First Posted: October 9, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: October 9, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will not share