Clinical trial NCT05687305: 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
Overall status: COMPLETED
Phase: NA
Conditions: Disc Herniation
Keywords: Lumbar Disc Herniation
White Noise
Sleep Quality
Comfort Level
Lead sponsor: Saglik Bilimleri Universitesi
Sponsor class: OTHER
First posted: 2023-01-18
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: OTHER

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 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.

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

Primary outcomes:
measure: Change of Sleep Quality Assessed by the Richard Campbell Sleep Scale
timeFrame: Change from baseline sleep quality at two days after surgery
measure: Change of Comfort Level Assessed by the General Comfort Questionnaire Short Form
timeFrame: Change from baseline comfort level at two days after surgery
measure: Change of Satisfaction Level Assessed by Visual Analogue Scale
timeFrame: Change from baseline satisfaction level at two days after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Melike Kızılkaya
Study officials:
affiliation: Saglik Bilimleri Universitesi
name: Melike Kızılkaya, RN
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.