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Completed

NCT Number: NCT06936384

The Effect of White Noise Sleep Mask on Patients' Sleep Quality and Comfort After Transurethral Resection of the Prostate (TUR-P) Surgery

One of the greatest challenges patients face in the postoperative period is the deterioration of sleep quality. Decreased sleep quality in the postoperative period is commonly observed due to pain, stress, anxiety, hospital environment noise, and environmental factors. Poor sleep quality can have negative effects on tissue healing, immune system activity, and overall well-being.

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Key information

Conditions

Surgical Procedures, Elective Nurse Based Care Management

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seda Cansu Yeniğün

Antalya, Kumluca, 07350, Turkey (Türkiye)

About this study

Transurethral prostate resection (TUR-P) is one of the most commonly performed surgical procedures for the treatment of benign prostatic hyperplasia (BPH). Patients undergoing TUR-P surgery may experience sleep problems in the postoperative period due to the use of urinary catheters, discomfort in the pelvic region, frequent urination urges, bladder spasms, and factors related to the hospital environment. Improving comfort and sleep quality during the recovery process for these patients may contribute to the improvement of their overall health status. White noise is a type of sound that contains all frequencies at equal intensity and helps mask environmental noises, allowing individuals to have a more restful sleep experience . Literature has reported positive effects of white noise, such as increasing sleep duration, reducing sleep onset time, and decreasing nighttime awakenings. Studies have shown that the use of white noise, particularly in hospital settings, improves sleep quality. For example, a study conducted in an intensive care unit reported that white noise significantly improved sleep quality by masking disruptive sounds in the hospital environment. Similarly, findings suggest that the use of white noise in the postoperative period helps patients experience deeper and uninterrupted sleep. White noise sleep masks can support the sleep process by both blocking environmental sounds and minimizing visual stimuli. Considering that factors such as lighting and noise in the hospital environment can lead to sleep disturbances, it is believed that white noise sleep masks may be effective in improving sleep quality in the postoperative period. This study aims to evaluate the effect of using a white noise sleep mask on sleep quality and comfort in patients after TUR-P surgery. The current literature on non-pharmacological approaches to improving sleep quality in patients after TUR-P is limited. Therefore, evaluating the effectiveness of white noise sleep masks is an important new intervention area that may contribute to postoperative patient care

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18 years of age or older,
  • No hearing and perception problems,
  • No visual impairment,
  • Will undergo elective TUR-P

Exclusion criteria

  • Use of any sleep/hypnotic medication or antidepressants before or after the procedure,
  • Having a psychiatric disorder.
  • Urgent surgery
  • Suffering from sleep apnea

Treatment and study plan

In this group, patients will be provided with a white noise sleep mask in accordance with the protocol determined for the postoperative period. Patients will sign an informed voluntary consent form be

Behavioral

White Noise Sleep Mask Group In this group, patients will be provided with a white noise sleep mask in accordance with the protocol determined for the postoperative period. Patients will sign an informed voluntary consent form before the surgery and fill out a patient information form.

Primary outcomes

  1. Visual Analog Scale-Comfort

    Time frame: Postop day 1

    It is a form consisting of a 10 cm long horizontal line used to assess the subjective discomfort of patients. It is used to determine many conditions. VAS is a measurement tool that is 0-10 cm (0-100 mm) long. This measurement tool can be used horizontally or vertically. The scale starts with "I am not comfortable at all" and ends with "I am perfectly comfortable".

  2. Visual Analog Scale-Comfort

    Time frame: Postop day 3

    It is a form consisting of a 10 cm long horizontal line used to assess the subjective discomfort of patients. It is used to determine many conditions. VAS is a measurement tool that is 0-10 cm (0-100 mm) long. This measurement tool can be used horizontally or vertically. The scale starts with "I am not comfortable at all" and ends with "I am perfectly comfortable".

  3. Sleep Quality

    Time frame: Postop day 1

    The scale, which consists of 6 items in total, is evaluated on a chart with numbers between 0 and 100, each of the 6 items evaluating the depth of night sleep, the time to fall asleep, the frequency of waking up, the time to stay awake when waking up, the quality of sleep and the level of noise in the environment. Scores in the range "0-25" indicate very poor sleep and scores in the range "76-100" indicate very good sleep. The increase in the scores on the scale increases in direct proportion to the sleep quality of the participants.

  4. Sleep Quality

    Time frame: Postop day 2

    The scale, which consists of 6 items in total, is evaluated on a chart with numbers between 0 and 100, each of the 6 items evaluating the depth of night sleep, the time to fall asleep, the frequency of waking up, the time to stay awake when waking up, the quality of sleep and the level of noise in the environment. Scores in the range "0-25" indicate very poor sleep and scores in the range "76-100" indicate very good sleep. The increase in the scores on the scale increases in direct proportion to the sleep quality of the participants.

  5. Sleep Quality

    Time frame: Postop day 3

    The scale, which consists of 6 items in total, is evaluated on a chart with numbers between 0 and 100, each of the 6 items evaluating the depth of night sleep, the time to fall asleep, the frequency of waking up, the time to stay awake when waking up, the quality of sleep and the level of noise in the environment. Scores in the range "0-25" indicate very poor sleep and scores in the range "76-100" indicate very good sleep. The increase in the scores on the scale increases in direct proportion to the sleep quality of the participants.

Sponsors and collaborators

Lead sponsor

Akdeniz University

Other

Registry information

Official study title

The Investigation of the Effect of White Noise Sleep Mask on Patients' Sleep Quality and Comfort After Transurethral Resection of the Prostate (TUR-P) Surgery: A Single-Blind Randomized Controlled Trial

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Apr 20, 2025
Registry last updated
Dec 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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