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

NCT06387888 — Not applicable, Completed, 60 participants, Istanbul Medipol University Hospital

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

Registry	NCT06387888, acronym Newborn
Status	Completed
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: single, supportive care
Enrollment	60 (Actual)
Sponsor	Istanbul Medipol University Hospital (Other)
Conditions	Newborns
Interventions	Listening to mother's voice (Other)
Dates	start 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 in Turkey (Türkiye)

-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.

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
Intervention group-30	Experimental	Other: Listening to mother's voice	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-30	No intervention		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.

Listening to mother's voice (Other): 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.

+Outcome measures

Primary outcomes

Neonatal Comfort Behavior Scale [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.

Secondary outcomes

Neonatal Comfort Behavior Scale (COMFORTneo): [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.

+Eligibility

Sex: All, ages: 3 Weeks to 41 Weeks, accepts healthy volunteers

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.

+Locations (1)

Facility	City	Country	Status
Istanbul Medipol University Hospital	Istanbul, Beykoz	Turkey (Türkiye)

+Investigators

Aysel Kökcü Doğan, Study director, Istanbul Medipol University Hospital

My Notes

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