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

NCT06387888 | Completed

• 1 other identifier: E-31034136-302.08.01-4221
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Newborns

Keywords

Comfort,; Mechanical ventilatör,; Mother's voice,; Newborn,; Pain

Outcome Measures

Primary Outcomes (1)

• Neonatal Comfort Behavior Scale

  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.

  20 minutes

Secondary Outcomes (1)

• Neonatal Comfort Behavior Scale (COMFORTneo):

  20 minutes

Study Arms (2)

Intervention group-30

EXPERIMENTAL

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.

Other: Listening to mother's voice

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.

Interventions

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.

Intervention group-30

Eligibility Criteria

• Age: 3 Weeks - 41 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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,

You may not qualify if:

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

Sponsors & Collaborators

• Istanbul Medipol University Hospital: lead

Study Sites (1)

Istanbul Medipol University Hospital

Istanbul, Beykoz, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Aysel Kökcü Doğan

  Istanbul Medipol University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: April 20, 2024
• First Posted: April 29, 2024
• Study Start: July 1, 2021
• Primary Completion: September 1, 2021
• Study Completion: April 30, 2022
• Last Updated: April 29, 2024

Record last verified: 2024-04

Locations

TU (1)