Ignite Creation Date:
2025-12-24 @ 2:53 PM
Ignite Modification Date:
2025-12-26 @ 1:49 PM
Study NCT ID:
NCT05203159
Status:
COMPLETED
Last Update Posted:
2023-11-18
First Post:
2021-12-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Ocean Sound In Premature Retinopathy Examination
Sponsor:
Necmettin Erbakan University
Organization:
Study Overview
Official Title:
The Effect of Ocean Sound on Physiological Parameters, Pain and Comfort Level In Premature Retinopathy Examination: A Randomized Controlled Study
Status:
COMPLETED
Status Verified Date:
2023-11
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:
Purpose: It was planned as a randomized controlled experiment in order to evaluate the effectiveness of the ocean sound on pain, comfort and physiological parameters in the NICU, Retinopathy of Prematurity (ROP) examination.
Design: This is single-center. randomized controlled trial, double blind, parallel.
Hypotheses:
H0a: There is no difference between the pain levels (scale score) of premature babies in the control group and the ocean sound group.
H0b: There is no difference between the comfort levels (scale score) of premature babies in the control group and the ocean sound group.
H0c: There is no difference between the physiological parameters of the premature babies in the control group and the ocean sound group.
H1a: There is a difference between the pain levels (scale score) of premature babies in the control group and the ocean sound group.
H1b: There is a difference between the comfort levels (scale score) of premature babies in the control group and the ocean sound group.
H1c: There is a difference between the physiological parameters of the premature babies in the control group and the ocean sound group.
Method:
The population of the research will be preterm babies who are treated at Necmettin Erbakan University Meram Medical Faculty NICU and will have their first ROP examination.
Premature babies to be included in the study will be assigned to two study groups using the quadruple balanced block randomization method created in the computer environment according to their gestational age.
In the study, the baby information form, Premature Baby Pain Profile Scale-Revised Form (PIPP-R), and Premature Baby Comfort Scale (PBIC) created by the researcher by scanning the literature will be used.
Data will be collected by researcher GA. Infants who meet the criteria for inclusion in the study will be selected from the infants who are planned to undergo an ROP examination, and written and verbal consent will be obtained from the families by explaining the purpose of the study before the application.
The information contained in the "Baby Information Form" will be obtained from the nurse observation form and patient files. On the day of the ROP examination, babies who meet the inclusion criteria before the procedure will be recorded outside the incubator with a video recorder in the room where the ROP examination will be performed (a room with 45-50 dB sound). Two minutes before the ROP, the baby will be monitored and physiological parameters will be recorded, and one minute before the ROP, the experimental group will start to listen to the ocean sound (Video recordings will be evaluated by two experts, PIPP-R and PBIC). After the necessary disinfection process is done, the voice recorder will be placed in the incubator at a distance of 20 cm from the baby's head and the sound level will be adjusted to an average of 55 decibels. The examination will begin with the placement of the speculum in the eye. The duration of the examination varies according to the visibility of the retinal vascularity, and the examination will end with the removal of the speculum from the eye. Ocean Sound Group; The ocean sound recording will continue to be played during the ROP examination. Control Group; No sound will be played before, during and after the ROP examination.
Physiological parameters will be recorded at the 1st and 5th minutes after the procedure. (Video recordings will be evaluated by two experts for PIPP-R and PBIC). Video recording will be stopped.Ocean Sound Group;The ocean sound recording will be played at the 5th minute after the ROP inspection. Control Group; No sound will be played before, during and after the ROP examination.
Design: This is single-center. randomized controlled trial, double blind, parallel.
Hypotheses:
H0a: There is no difference between the pain levels (scale score) of premature babies in the control group and the ocean sound group.
H0b: There is no difference between the comfort levels (scale score) of premature babies in the control group and the ocean sound group.
H0c: There is no difference between the physiological parameters of the premature babies in the control group and the ocean sound group.
H1a: There is a difference between the pain levels (scale score) of premature babies in the control group and the ocean sound group.
H1b: There is a difference between the comfort levels (scale score) of premature babies in the control group and the ocean sound group.
H1c: There is a difference between the physiological parameters of the premature babies in the control group and the ocean sound group.
Method:
The population of the research will be preterm babies who are treated at Necmettin Erbakan University Meram Medical Faculty NICU and will have their first ROP examination.
Premature babies to be included in the study will be assigned to two study groups using the quadruple balanced block randomization method created in the computer environment according to their gestational age.
In the study, the baby information form, Premature Baby Pain Profile Scale-Revised Form (PIPP-R), and Premature Baby Comfort Scale (PBIC) created by the researcher by scanning the literature will be used.
Data will be collected by researcher GA. Infants who meet the criteria for inclusion in the study will be selected from the infants who are planned to undergo an ROP examination, and written and verbal consent will be obtained from the families by explaining the purpose of the study before the application.
The information contained in the "Baby Information Form" will be obtained from the nurse observation form and patient files. On the day of the ROP examination, babies who meet the inclusion criteria before the procedure will be recorded outside the incubator with a video recorder in the room where the ROP examination will be performed (a room with 45-50 dB sound). Two minutes before the ROP, the baby will be monitored and physiological parameters will be recorded, and one minute before the ROP, the experimental group will start to listen to the ocean sound (Video recordings will be evaluated by two experts, PIPP-R and PBIC). After the necessary disinfection process is done, the voice recorder will be placed in the incubator at a distance of 20 cm from the baby's head and the sound level will be adjusted to an average of 55 decibels. The examination will begin with the placement of the speculum in the eye. The duration of the examination varies according to the visibility of the retinal vascularity, and the examination will end with the removal of the speculum from the eye. Ocean Sound Group; The ocean sound recording will continue to be played during the ROP examination. Control Group; No sound will be played before, during and after the ROP examination.
Physiological parameters will be recorded at the 1st and 5th minutes after the procedure. (Video recordings will be evaluated by two experts for PIPP-R and PBIC). Video recording will be stopped.Ocean Sound Group;The ocean sound recording will be played at the 5th minute after the ROP inspection. Control Group; No sound will be played before, during and after the ROP examination.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
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?: