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Laparoscopic CholecystectomyNCT07867613

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

A study testing White Noise in people with Laparoscopic Cholecystectomy, run by Ataturk University.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Laparoscopic Cholecystectomy
What is being tested?
White Noise
Could I receive a placebo?
No, everyone receives an active treatment
How many people
64 participants
Where
No sites listed yet
Study dates
1 Oct 2026to 1 Aug 2027
Phase
Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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,
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  • 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

Who cannot join

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

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Tülay KILINÇ, PhD contact

05376592051

tlyhmsre@hotmail.com

Tülay KILINÇ, PhD contact

05376592051

ayseguul21@hotmail.com

About this study

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.

Read the detailed description

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/vomiting; 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.

Non-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.

These 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.

In 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.

Being tested
White Noise
Keywords
White Noise, Sleep Quality, Quality of Recovery, Patient Satisfaction, Laparoscopic Cholecystectomy
Medical subject headings
Sleep Initiation and Maintenance Disorders, Patient Satisfaction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • White NoiseOther

    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.

Study groups in NCT07867613
Study groupRoleWhat they receive
Control GroupNo interventionParticipants will receive routine postoperative care without white noise
White NoiseExperimentalParticipants will receive white noise in addition to routine postoperative care
Receives: Other: White Noise

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Postoperative days 1 and 2

  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.

    Measured: Postoperative days 1 and 2

  3. 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.

    Measured: Postoperative days 2

Secondary outcomes (1)
  1. 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.

    Measured: Postoperative days 1 and 2

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Oct 2026
  2. Study start1 Oct 2026 (estimated)
  3. Primary completion1 Aug 2027 (estimated)
  4. Study completion1 Aug 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
64 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07867613
Sponsor's protocol ID
tulay27
Status last verified
Oct 2026
First submitted
18 Sep 2026
Last updated
9 Oct 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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