Effect of Maternal Heart Sound on Crying Time and Pain Level in Newborns During Heel Blood Collection

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-01

Study Completion Date

2020-03-01

Brief Summary

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This study was carried out to determine the effect of maternal heart sound listened to by newborns during heel blood collection on pain level and crying time.

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Detailed Description

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The randomized controlled and experimental study was conducted with 60 newborns applied to a public family health center for heel blood collection. The infants in the experimental group (n=30) were listened to the maternal heart sound before, during, and after the heel blood collection procedure, and routine blood collection was applied to the control group (n=30). Newborn Information Form and Newborn Infant Pain Scale (NIPS) were used to collect data.

Conditions

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Pain Infant, Newborn, Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The study is a randomized controlled trial.

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

The two separate clinicians conducting the assessment were masked to allow for impartiality.

Study Groups

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Control Group

Routine heel blood was taken from the control group. At the same time, the behaviors of newborns were recorded on camera throughout the procedure. At the end of the study, the camera recording was watched and scored by two midwives who had training in the Neonatal Pain Scale.

Group Type NO_INTERVENTION

No interventions assigned to this group

Experimental Group

The newborns in the experimental group listened to the recorded heart sounds of their mothers for 1 minute before the heel blood procedure, during the procedure and for 1 minute after the procedure. At the same time, the behaviors of newborns were recorded on camera throughout the procedure. At the end of the study, the camera recording was monitored and scored by two midwives trained in the Neonatal Pain Scale.

Group Type EXPERIMENTAL

Listening the maternal heart sound during the invasive interventions

Intervention Type OTHER

Heart sounds of the newborns' own mothers were recorded on the voice recorder with the help of a hand doppler device. This sound was listened by the newborns in the experimental group during the heel blood procedure.

Interventions

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Listening the maternal heart sound during the invasive interventions

Heart sounds of the newborns' own mothers were recorded on the voice recorder with the help of a hand doppler device. This sound was listened by the newborns in the experimental group during the heel blood procedure.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Gestational age of 38-41 weeks,
* Chronological age of 2-28 days,
* Without any physical, metabolic or genetic disease,
* Newborns who did not use any analgesic drugs before the procedure