Ignite Creation Date:
2024-05-06 @ 8:26 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06387888
Status:
COMPLETED
Last Update Posted:
2024-04-29
First Post:
2024-04-20
Brief Title:
The Effect of Mothers Voice on the Levels of Pain and Comfort in Newborns
Sponsor:
Istanbul Medipol University Hospital
Organization:
Istanbul Medipol University Hospital
Study Overview
Official Title:
The Effect of Mothers Voice on the Levels of Pain and Comfort in Newborns on Mechanical Ventilation a Randomized Controlled Study
Status:
COMPLETED
Status Verified Date:
2024-04
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:
Newborn
Brief Summary:
This study was conducted in a randomized controlled experimental type to determine the effect of maternal voice during care on pain and comfort level in term newborns receiving mechanical ventilation The sample of the study was consisted of 60 term newborns receiving mechanical ventilation who were hospitalized in the 7-bed Neonatal Intensive Care Unit of a private hospital in Istanbul in accordance with the selection criteria Introductory Information Form Vital Signs Follow-up Form Neonatal Comfort Behavior Scale and Neonatal Pain Scale NPASS forms prepared by the researchers were used as data collection tools
Detailed Description:
Intervention group During the care from the beginning to the end mothers voice was played to the newborns It took about 20 minutes The mini Bluetooth speaker and the decibel meter were disinfected with the rapid surface disinfectant used in the clinic The speaker was placed 30 cm away from the infants ear and the sound level in the incubator was adjusted to be 50-60 dB by using a decibel meter Mothers voice was played from the beginning of the provision of care and continued for 15 minutes after the end of the provision of care During the provision of care COMFORTneo scores pain scores and vital signs were measured and recorded on the vital signs follow-up form
Control group Standard nursing care lasting 20 minutes was performed in the routine sound environment of the neonatal intensive care unit COMFORTneo scores pain scores and vital signs were measured and recorded on the vital signs follow-up form
Control group Standard nursing care lasting 20 minutes was performed in the routine sound environment of the neonatal intensive care unit COMFORTneo scores pain scores and vital signs were measured and recorded on the vital signs follow-up form
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?:
None