Surgical Procedures, ElectiveNCT06936384
The Effect of White Noise Sleep Mask on Patients' Sleep Quality and Comfort After Transurethral Resection of the Prostate (TUR-P) Surgery
A study testing 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 in people with Surgical Procedures, Elective and Nurse Based Care Management, run by Akdeniz University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Surgical Procedures, Elective, Nurse Based Care Management
- What is being tested?
- 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
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 19 Apr 2025to 20 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years of age or older,
- No hearing and perception problems,
- No visual impairment,
- Will undergo elective TUR-P
Who cannot join
- Use of any sleep/hypnotic medication or antidepressants before or after the procedure,
- Having a psychiatric disorder.
- Urgent surgery
- Suffering from sleep apnea
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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.
Read the detailed description
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
- Being tested
- 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
- Keywords
- White noise, sleep mask, surgical nursing, TUR-P, Transurethral Resection of the Prostate, surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 beBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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".
Measured: 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".
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Postop day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2025
- Study start19 Apr 2025
- Primary completion30 Oct 2025
- Study completion20 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical Procedures, ElectiveStudies of the same condition, open and under way.
- More trials run by Akdeniz UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Akdeniz University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seda Cansu Yeniğün, Akdeniz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06936384
- Sponsor's protocol ID
- White19999172490
- Status last verified
- Nov 2025
- First submitted
- 13 Apr 2025
- Last updated
- 1 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06936384
- Acronym / sponsor ID
- White19999172490
- Keywords
- White noise, sleep mask, surgical nursing, TUR-P, Transurethral Resection of the Prostate, surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Akdeniz UniversityUniversity, hospital or other
- Study start
- 19 Apr 2025 (actual)
- Primary completion
- 30 Oct 2025 (actual)
- Study completion
- 20 Nov 2025 (actual)
- First posted
- 20 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | 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 beWhite 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years of age or older,
- No hearing and perception problems,
- No visual impairment,
- Will undergo elective TUR-P
Key exclusion criteria (4 listed)
- Use of any sleep/hypnotic medication or antidepressants before or after the procedure,
- Having a psychiatric disorder.
- Urgent surgery
- Suffering from sleep apnea
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 beWhite 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. | Behavioural | White Noise Sleep Mask Group |
Primary outcome
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".
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".
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 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 in people with Surgical Procedures, Elective and Nurse Based Care Management, run by Akdeniz University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale-Comfort (time frame: Postop day 1). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2025.