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

March 28, 2024 updated by: Elif Gezginci, Saglik Bilimleri Universitesi

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey, 34255
        • Melike Kızılkaya

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: 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.
Active Comparator: 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.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of Sleep Quality Assessed by the Richard Campbell Sleep Scale
Time Frame: Change from baseline sleep quality at two days after surgery
The sleep quality of the patients was evaluated with the Richard Campbell Sleep Scale on the 1st and 2nd 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 two days after surgery
Change of Comfort Level Assessed by the General Comfort Questionnaire Short Form
Time Frame: Change from baseline comfort level at two days after surgery
The general comfort levels of the patients were evaluated with the General Comfort Questionnaire Short Form after the morning treatment on the 1st and 2nd 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 two days after surgery
Change of Satisfaction Level Assessed by Visual Analogue Scale
Time Frame: Change from baseline satisfaction level at two days after surgery
The satisfaction levels of the patients were evaluated with the Visual Analogue Scale on the 1st and 2nd 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 two days after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Saglik Bilimleri Universitesi

Investigators

  • Principal Investigator: Melike Kızılkaya, RN, Saglik Bilimleri Universitesi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 25, 2022

Primary Completion (Actual)

February 28, 2023

Study Completion (Actual)

January 30, 2024

Study Registration Dates

First Submitted

December 30, 2022

First Submitted That Met QC Criteria

January 17, 2023

First Posted (Actual)

January 18, 2023

Study Record Updates

Last Update Posted (Actual)

March 29, 2024

Last Update Submitted That Met QC Criteria

March 28, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 27.05.2022-22-36

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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