- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06936384
The Effect of White Noise Sleep Mask on Patients' Sleep Quality and Comfort After Transurethral Resection of the Prostate (TUR-P) Surgery
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
Study Overview
Status
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Kumluca
-
Antalya, Kumluca, Turkey (Türkiye), 07350
- Seda Cansu Yeniğün
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control Group
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.
During this process, no additional mask or intervention will be applied; only routine postoperative care procedures will be followed. |
|
|
Experimental: White Noise Sleep Mask Group
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 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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".
|
Postop day 1
|
|
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".
|
Postop day 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.
|
Postop day 1
|
|
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.
|
Postop day 2
|
|
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.
|
Postop day 3
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- White19999172490
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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