Clinical trial NCT06387888: The Effect of Mother's Voice on the Levels of Pain and Comfort in Newborns
Official title: The Effect of Mother's Voice on the Levels of Pain and Comfort in Newborns on Mechanical Ventilation: a Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Newborns
Keywords: Comfort,
Mechanical ventilatör,
Mother's voice,
Newborn,
Pain
Lead sponsor: Istanbul Medipol University Hospital
Sponsor class: OTHER
First posted: 2024-04-29
Enrollment: 60
Sex: ALL
Minimum age (years): 3
Maximum age (years): 41
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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, 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.

Eligibility criteria: Inclusion Criteria:

* Connected to a mechanical ventilator (intubation or nasal CPAP),
* Term newborns (born at 37-42 weeks),
* No neurological disorders,
* No congenital or acquired hearing malformations,
* The family consents for their infant to participate in the study,

Exclusion Criteria:

* Diagnosis of asphyxia,
* Use of sedatives or analgesics,
* Congenital anomaly,
* Underwent an extra invasive procedure or surgical intervention,
* Parents with congenital hearing problems.

Primary outcomes:
measure: Neonatal Comfort Behavior Scale
timeFrame: 20 minutes
Secondary outcomes:
measure: Neonatal Comfort Behavior Scale (COMFORTneo):
timeFrame: 20 minutes
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Medipol University Hospital
state: Beykoz
Study officials:
affiliation: Istanbul Medipol University Hospital
name: Aysel Kökcü Doğan
role: STUDY_DIRECTOR
References: