Ignite Creation Date:
2025-12-25 @ 3:10 AM
Ignite Modification Date:
2025-12-26 @ 1:49 AM
Study NCT ID:
NCT05687305
Status:
COMPLETED
Last Update Posted:
2024-03-29
First Post:
2022-12-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effect of White Noise in Patients Undergoing Lumbar Disc Herniation Surgery
Sponsor:
Saglik Bilimleri Universitesi
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
* 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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: