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CompletedNCT05520164Updated Sep 2, 2022

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

An interventional study of Listening the maternal heart sound during the invasive interventions in Pain and Infant, Newborn, Disease, sponsored by Saglik Bilimleri Universitesi. Completed at 1 site in Turkey (Türkiye). Open to participants aged 2 Days to 28 Days, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-09-02.

Sponsored by Saglik Bilimleri Universitesi · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 2 years 10 months after the study started (first participant enrolled Oct 2019, registered Aug 2022).
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
2 Days to 28 Days
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Pain
  • Infant, Newborn, Disease

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Keywords

  • Pain
  • Newborn
  • Non-Drug Pain Management
03

In context

Pain

2,450 studies on the registry are indexed under Pain; 945 are open to participants now.

This study's enrollment of 60 is below the median of 70 across 2,101 interventional studies indexed under Pain.

Browse Pain studies →

Lead sponsor

Saglik Bilimleri Universitesi is the lead sponsor of 447 studies on the registry; 138 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
2 Days to 28 Days
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Newborns whose heel blood cannot be taken at once
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Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
60 participants (actual)

Study arms

  • No intervention
    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.

  • Experimental
    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.

    Other: Listening the maternal heart sound during the invasive interventions

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.

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What researchers measure

Primary outcomes

  1. The Newborn Infant Pain Scale (NIPS)

    The 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.

    Time frame: 15 minutes

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Study locations

1 site
  • Pendik Mehmet Oguz Family Health Center
    Istanbul, 34668, Turkey (Türkiye)
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References and documents

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 2, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05520164
Collaborators
Pendik District Health Directorate
Responsible party
Sponsor
First posted
Aug 29, 2022
Start date
Oct 1, 2019
Primary completion
Feb 1, 2020
Completion
Mar 1, 2020
Last update
Sep 2, 2022

Study contacts

Sümeyye KOSE, Phd Student
principal investigator · Pendik District Health Directorate
Besey OREN, Associate Prof
study director · Saglik Bilimleri Universitesi

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.

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