Clinical Trials Directory

Trials / Completed

CompletedNCT06387888

The Effect of Mother's Voice on the Levels of Pain and Comfort in Newborns

The Effect of Mother's Voice on the Levels of Pain and Comfort in Newborns on Mechanical Ventilation: a Randomized Controlled Study

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
60 (actual)
Sponsor
Istanbul Medipol University Hospital · Academic / Other
Sex
All
Age
3 Weeks – 41 Weeks
Healthy volunteers
Accepted

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, mother's 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 infant's ear and the sound level in the incubator was adjusted to be 50-60 dB by using a decibel meter Mother's 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.

Conditions

Interventions

TypeNameDescription
OTHERListening to mother's voiceDuring the care, from the beginning to the end, mother's 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 infant's ear and the sound level in the incubator was adjusted to be 50-60 dB by using a decibel meter (Official Gazette, 2018). Mother's 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.

Timeline

Start date
2021-07-01
Primary completion
2021-09-01
Completion
2022-04-30
First posted
2024-04-29
Last updated
2024-04-29

Locations

1 site across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT06387888. Inclusion in this directory is not an endorsement.