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

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

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.

Study Overview

• Status: Completed
• Conditions: Newborns
• Intervention / Treatment: Other: Listening to mother's voice

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Beykoz
    • Istanbul, Beykoz, Turkey
      • Istanbul Medipol University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group-30; 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; 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.
No Intervention: Control group-30; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neonatal Comfort Behavior Scale (COMFORTneo):	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.	20 minutes

Collaborators and Investigators

• Sponsor: Istanbul Medipol University Hospital
• Investigators: Study Director: Aysel Kökcü Doğan, Istanbul Medipol University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2021
• Primary Completion (Actual): September 1, 2021
• Study Completion (Actual): April 30, 2022

Study Registration Dates

• First Submitted: April 20, 2024
• First Submitted That Met QC Criteria: April 25, 2024
• First Posted (Actual): April 29, 2024

Study Record Updates

• Last Update Posted (Actual): April 29, 2024
• Last Update Submitted That Met QC Criteria: April 25, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Pain; Comfort,; Newborn,; Mechanical ventilatör,; Mother's voice,
• Other Study ID Numbers: E-31034136-302.08.01-4221

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No