The Effect of White Noise in Patients Undergoing Lumbar Disc Herniation Surgery
NCT ID: NCT05687305
Last Updated: 2024-03-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
60 participants
INTERVENTIONAL
2022-05-25
2024-01-30
Brief Summary
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* 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.
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Detailed Description
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On the 0th and 1st 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
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.
OTHER
SINGLE
Study Groups
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Intervention Group
On the 0th and 1st 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.
White Noise
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 0th and 1st 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.
No Intervention Group
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.
No interventions assigned to this group
Interventions
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White Noise
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 0th and 1st 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.
Eligibility Criteria
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Inclusion Criteria
* hospitalized for at least 48 hours
* agreed to participate in research
Exclusion Criteria
* Not filling out the questionnaire
18 Years
65 Years
ALL
Yes
Sponsors
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Saglik Bilimleri Universitesi
OTHER
Responsible Party
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Elif Gezginci
Assoc. Prof.
Principal Investigators
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Melike Kızılkaya, RN
Role: PRINCIPAL_INVESTIGATOR
Saglik Bilimleri Universitesi
Locations
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Melike Kızılkaya
Istanbul, , Turkey (Türkiye)
Countries
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References
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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.
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.
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.
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.
Other Identifiers
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27.05.2022-22-36
Identifier Type: -
Identifier Source: org_study_id
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