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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05520164
• Other study ID #: Saglik Bilimleri U
• Status: Completed
• Phase: N/A
• Start date: October 1, 2019
• Est. completion date: March 1, 2020

Study information

• Verified date: August 2022
• Source: Saglik Bilimleri Universitesi
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 1, 2020
• Est. primary completion date: February 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Days to 28 Days

Eligibility

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

Related Conditions & MeSH terms

• Infant, Newborn, Disease
• Infant, Newborn, Diseases
• Pain

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Turkey	Pendik Mehmet Oguz Family Health Center	Istanbul

Sponsors (2)

Lead Sponsor	Collaborator
Saglik Bilimleri Universitesi	Pendik District Health Directorate

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	15 minutes

External Links

•   Effect of inhalation aromatherapy with lavender essence on pain associated with intravenous catheter insertion in preschool children: a quasi-experimental study. Com
•   Effect of interactive distraction versus cutaneous stimulation for venipuncture pain relief in school age children.
•   Pain control with lavender oil in premature infants: a double-blind randomized controlled study. The Journal of Alternative and Complementary Medicine, 27(2), 136-141.