Skip to main content
Clinical Trials/NCT05687305
NCT05687305
Completed
Not Applicable

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

Saglik Bilimleri Universitesi1 site in 1 country60 target enrollmentMay 25, 2022
ConditionsDisc Herniation

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Disc Herniation
Sponsor
Saglik Bilimleri Universitesi
Enrollment
60
Locations
1
Primary Endpoint
Change of Satisfaction Level Assessed by Visual Analogue Scale
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 25, 2022
End Date
January 30, 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Elif Gezginci

Assoc. Prof.

Saglik Bilimleri Universitesi

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

Outcomes

Primary Outcomes

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 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 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.

Study Sites (1)

Loading locations...

Similar Trials