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

Primary Purpose

Disc Herniation

Status
Active
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
White Noise
Sponsored by
Saglik Bilimleri Universitesi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Disc Herniation focused on measuring Lumbar Disc Herniation, White Noise, Sleep Quality, Comfort Level

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Melike Kızılkaya

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Intervention Group

No Intervention Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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 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 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.

Secondary Outcome Measures

Full Information

First Posted
December 30, 2022
Last Updated
January 17, 2023
Sponsor
Saglik Bilimleri Universitesi
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1. Study Identification

Unique Protocol Identification Number
NCT05687305
Brief Title
The Effect of White Noise in Patients Undergoing Lumbar Disc Herniation Surgery
Official Title
The Effect of White Noise on Sleep Quality, Comfort and Satisfaction Level in Patients Undergoing Lumbar Disc Herniation Surgery: A Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 25, 2022 (Actual)
Primary Completion Date
February 28, 2023 (Anticipated)
Study Completion Date
April 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Saglik Bilimleri Universitesi

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Disc Herniation
Keywords
Lumbar Disc Herniation, White Noise, Sleep Quality, Comfort Level

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention Group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
No Intervention Group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
White Noise
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change of Sleep Quality Assessed by the Richard Campbell Sleep Scale
Description
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.
Time Frame
Change from baseline sleep quality at three days after surgery
Title
Change of Comfort Level Assessed by the General Comfort Questionnaire Short Form
Description
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.
Time Frame
Change from baseline comfort level at three days after surgery
Title
Change of Satisfaction Level Assessed by Visual Analogue Scale
Description
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.
Time Frame
Change from baseline satisfaction level at three days after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Melike Kızılkaya, RN
Organizational Affiliation
Saglik Bilimleri Universitesi
Official's Role
Principal Investigator
Facility Information:
Facility Name
Melike Kızılkaya
City
Istanbul
ZIP/Postal Code
34255
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26444713
Citation
Murase K, Tabara Y, Ito H, Kobayashi M, Takahashi Y, Setoh K, Kawaguchi T, Muro S, Kadotani H, Kosugi S, Sekine A, Yamada R, Nakayama T, Mishima M, Matsuda S, Matsuda F, Chin K. Knee Pain and Low Back Pain Additively Disturb Sleep in the General Population: A Cross-Sectional Analysis of the Nagahama Study. PLoS One. 2015 Oct 7;10(10):e0140058. doi: 10.1371/journal.pone.0140058. eCollection 2015.
Results Reference
result
PubMed Identifier
19363455
Citation
Chou R, Baisden J, Carragee EJ, Resnick DK, Shaffer WO, Loeser JD. Surgery for low back pain: a review of the evidence for an American Pain Society Clinical Practice Guideline. Spine (Phila Pa 1976). 2009 May 1;34(10):1094-109. doi: 10.1097/BRS.0b013e3181a105fc.
Results Reference
result
PubMed Identifier
15480148
Citation
Kavcic N, Grenier S, McGill SM. Quantifying tissue loads and spine stability while performing commonly prescribed low back stabilization exercises. Spine (Phila Pa 1976). 2004 Oct 15;29(20):2319-29. doi: 10.1097/01.brs.0000142222.62203.67.
Results Reference
result
PubMed Identifier
32838628
Citation
Akiyama A, Tsai JD, W Y Tam E, Kamino D, Hahn C, Go CY, Chau V, Whyte H, Wilson D, McNair C, Papaioannou V, Hugh SC, Papsin BC, Nishijima S, Yamazaki T, Miller SP, Ochi A. The Effect of Music and White Noise on Electroencephalographic (EEG) Functional Connectivity in Neonates in the Neonatal Intensive Care Unit. J Child Neurol. 2021 Jan;36(1):38-47. doi: 10.1177/0883073820947894. Epub 2020 Aug 24.
Results Reference
result

Learn more about this trial

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

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