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

Effect of Maternal Heart Sound on Crying Time and Pain Level in Newborns During Heel Blood Collection: A Randomized Controlled Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05520164
Enrollment
60
Registered
2022-08-29
Start date
2019-10-01
Completion date
2020-03-01
Last updated
2022-09-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infant, Newborn, Disease, Pain

Keywords

Pain, Newborn, Non-Drug Pain Management

Brief summary

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.

Detailed description

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.

Interventions

OTHERListening 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.

Sponsors

Pendik District Health Directorate
CollaboratorOTHER_GOV
Saglik Bilimleri Universitesi
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)

Masking description

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

Intervention model description

The study is a randomized controlled trial.

Eligibility

Sex/Gender
ALL
Age
2 Days to 28 Days
Healthy volunteers
Yes

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

Exclusion criteria

* Newborns whose heel blood cannot be taken at once

Design outcomes

Primary

MeasureTime frameDescription
The Newborn Infant Pain Scale (NIPS)15 minutesThe Newborn Infant Pain Scale (NIPS) was used. NIPS: Scale Lawrence et al. (1993) was developed to evaluate the behavioral and physiological pain responses of preterm and term infants. The scale consists of five behavioral factors (facial expression, crying, arousal, arm and leg movements) and one physiological (breathing pattern) factor. The crying factor is given 0-1-2 points, the other factors are given 0-1 points, and the total score is between 0-7. A high score indicates greater severity of pain.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026