Istanbul Medipol University Hospital
Istanbul, Beykoz, Turkey (Türkiye)
NCT Number: NCT06387888
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.
Looking for future studies?
Notify Me3 week–41 week
All sexes
Interventional
Not applicable
Istanbul, Beykoz, Turkey (Türkiye)
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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 (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.
Time frame: 20 minutes
The scale is for 0-100-day-old infants and term or preterm newborns experiencing acute or chronic pain and treated with or without mechanical ventilation.
Time frame: 20 minutes
COMFORTneo consists of 7 items on alertness, calmness/agitation, respiratory response, crying, body movement, facial tension, and muscle tone. Of these items, "respiratory response" is evaluated in newborns on mechanical ventilation and "crying" is evaluated in spontaneously breathing newborns.
Istanbul Medipol University Hospital
Other
The Effect of Mother's Voice on the Levels of Pain and Comfort in Newborns on Mechanical Ventilation: a Randomized Controlled Study
Acronym: Newborn
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06350071
Acute Pain, Behavior
Burdur, Bucak, Turkey (Türkiye)
View Trial DetailsNCT06944054
Newborns
Ankara, Turkey (Türkiye)
View Trial DetailsNCT04492579
Behavior, Breast Feeding
Port Saint Lucie, Florida, United States
View Trial DetailsNCT03637894
Innate Immunity, Microbiota
Milan, Italy
View Trial Details