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

NCT06936384 | Completed DMC

• 1 other identifier: White19999172490
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Surgical Procedures, Elective; Nurse Based Care Management

Keywords

White noise; sleep mask; surgical nursing; TUR-P; Transurethral Resection of the Prostate; surgery

Outcome Measures

Primary Outcomes (5)

• Visual Analog Scale-Comfort

  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".

  Postop day 1

• Visual Analog Scale-Comfort

  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".

  Postop day 3

• Sleep Quality

  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.

  Postop day 1

• Sleep Quality

  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.

  Postop day 2

• Sleep Quality

  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.

  Postop day 3

Study Arms (2)

Control Group

NO INTERVENTION

In this group of patients, standard care will be applied during the postoperative period. Patients will sign an informed voluntary consent form before the surgery and fill out a patient information form. * Postoperative Day 1: Comfort level will be measured in the morning using the Richard Campbell Sleep Scale and the Visual Analog Scale (VAS). Patients will receive standard postoperative care without any additional interventions. * Postoperative Day 2: Reassessment will be done in the morning using the Richard Campbell Sleep Scale. Patients will be monitored according to standard care protocols during the postoperative process. * Postoperative Day 3: The final comfort assessment will be conducted using the Richard Campbell Sleep Scale and VAS. During this process, no additional mask or intervention will be applied; only routine postoperative care procedures will be followed.

White Noise Sleep Mask Group

EXPERIMENTAL

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. * Postoperative Day 1: Comfort level will be measured in the morning using the Richard Campbell Sleep Scale and the Visual Analog Scale (VAS). On the same day, in the morning, the nurse will recommend the patient use the white noise sleep mask twice a day for two hours. In the evening, the researcher will visit the hospital to ensure the mask is applied. * Postoperative Day 2: Reassessment will be done in the morning using the Richard Campbell Sleep Scale, and the mask usage will continue twice a day for two hours. * Postoperative Day 3: The final comfort assessment will be conducted using the Richard Campbell Sleep Scale and VAS.

Behavioral: 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

Interventions

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.

White Noise Sleep Mask Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Akdeniz University: lead

Study Sites (1)

Seda Cansu Yeniğün

Antalya, Kumluca, 07350, Turkey (Türkiye)

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer Dr

Study Record Dates

• First Submitted: April 13, 2025
• First Posted: April 20, 2025
• Study Start: April 19, 2025
• Primary Completion: October 30, 2025
• Study Completion: November 20, 2025
• Last Updated: December 1, 2025

Record last verified: 2025-11

Locations

TU (1)