The Effect of White Noise in Patients Undergoing Lumbar Disc Herniation Surgery

Study Overview
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Brief Summary
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The aim of this clinical trial is to determine the effectiveness of listening to white noise on the sleep quality, comfort level, satisfaction level of patients after lumbar disc herniation surgery. The main hypotheses are: Is there a difference between the sleep quality of patients who listen to white noise and those who do not? Is there a difference between the comfort levels of patients who listen to white noise and those who do not? Is there a difference between the satisfaction levels of patients who listen to white noise and those who do not? The main tasks that the participants will be asked to do will be explained and Their informed consent will be obtained. The two research groups will be compared.

Detailed Description
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This study will be conducted with a total of 60 patients who underwent surgery for lumbar disc herniation at a hospital in Istanbul. Participants in the study who had lumbar disc herniation surgery will be divided into two groups: intervention (n = 30) and control group (n = 30), according to the randomization method created with computer-based random numbers. On the 1st and 2nd postoperative days, patients in the intervention group will listen to white noise with a bluetooth headset for 30 minutes before going to sleep, and they will be kept under observation during this time.Patients in the control group will be monitored according to their routine clinical procedures. Since there are no procedures or interventions in clinical procedures, only patient monitoring will be performed. Patients in the control group will also be followed up at the same times and with the same forms. Descriptive Characteristics Form, Informed Consent Form, The Richards-Campbell Sleep Questionnaire, General Comfort Questionnaire,Visual Analog Scale for Satisfaction Level will be used in data collection.

Official Title
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The Effect of White Noise on Sleep Quality, Comfort and Satisfaction Level in Patients Undergoing Lumbar Disc Herniation Surgery: A Randomized Controlled Study

Conditions
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Disc Herniation

Intervention / Treatment
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* Other: White Noise


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: underwent lumbar disc herniation surgery hospitalized for at least 48 hours agreed to participate in research Exclusion Criteria: chronic sleep problems and taking medication Not filling out the questionnaire

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This study is a single-center parallel-group randomized controlled clinical trial. Participants who accepted to participate in the study and met the inclusion criteria will be assigned to the intervention (n=30) or control group (n=30) according to the computer-based randomization table.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intervention Group<br>On the 1st and 2nd postoperative days, patients in the intervention group will listen to white noise with a bluetooth headset for 30 minutes before going to sleep, and they will be kept under observation during this time.Patients in the control group will be monitored according to their routine clinical procedures. Since there are no procedures or interventions in clinical procedures, only patient monitoring will be performed. Patients in the control group will also be followed up at the same times and with the same forms. | Other: White Noise<br>* White noise is produced by digitally combining sounds of equal frequency in the laboratory. Then, all of the frequencies in this sound are calibrated to generate noise at each frequency. If the contribution of each region to the noise level is the same, the noise is referred to as white noise. Waterfalls, ocean waves, and wind blowing through trees all produce similar to white noise. Patients in the intervention group are observed by the investigator on the 1st and 2nd postoperative days.Before going to sleep, a bluetooth headset will be used to listen to white noise for 30 minutes and vital signs will be measured before and after the procedure.<br>|
| No Intervention: No Intervention Group<br>Patients in the control group will not receive any intervention other than their routine. Data collection forms will be applied to the participants in the control group at the same time as the intervention group. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Sleep Quality Assessed by the Richard Campbell Sleep Scale | The sleep quality of the patients was evaluated with the Richard Campbell Sleep Scale on the 1st, 2nd and 3rd postoperative days after morning treatment. This scale consists of 6 items and the total score range is 0-100 points. As the scale score increases, the sleep quality of the patients also increases. | Change from baseline sleep quality at three days after surgery | 
| Change of Comfort Level Assessed by the General Comfort Questionnaire Short Form | The general comfort levels of the patients were evaluated with the General Comfort Questionnaire Short Form after the morning treatment on the 1st and 3rd postoperative days. This scale consists of 28 items and includes three sub-dimensions; comfort, relaxation and relaxation. The scale score is calculated by dividing the total score obtained from the scale by the number of scale items. The scale total score range is between 0-6 points. As the scale score increases, the comfort level of the patients also increases. | Change from baseline comfort level at three days after surgery | 
| Change of Satisfaction Level Assessed by Visual Analogue Scale | The satisfaction levels of the patients were evaluated with the Visual Analogue Scale on the 1st and 3rd postoperative days, after the morning treatment. This scale consists of 10 cm horizontal lines and is evaluated between 0-10 points. As the scale score increases, the satisfaction level of the patients also increases. | Change from baseline satisfaction level at three days after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lumbar Disc Herniation, White Noise, Sleep Quality, Comfort Level