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Clinical Trials/NCT05526378
NCT05526378
Completed
Not Applicable

Effect of Three Different Sensory Interventions on Pain Level During Heel Blood Collection in Term Infant: a Randomized Controlled Study

Istanbul University - Cerrahpasa (IUC)1 site in 1 country120 target enrollmentDecember 22, 2022
ConditionsInfantPain

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Infant
Sponsor
Istanbul University - Cerrahpasa (IUC)
Enrollment
120
Locations
1
Primary Endpoint
NIPS scale
Status
Completed
Last Updated
last year

Overview

Brief Summary

Background: Healthy newborns undergo many painful procedures in the first hours of life. Damage caused by painful procedures can lead to structural and functional changes that can affect adult life. Various non-pharmacological methods have been reported in the literature for pain management. The aim of the study is to investigate the effect of the method that appeals to 3 different senses (mother's voice, breast milk smell, mother's contact) on the level of pain during heel blood collection.

Method: The population of the study consisted of babies who were hospitalized in a hospital's neonatal unit between December 2022 and May 2023 and who heel blood taken. The Neonatal-Infant Pain (NIPS) Scale and data collection form were used to obtain the data. 120 newborns who met the study criteria were randomly divided into group 1 (n=30) , group 2 (n=30), group 3 (n=30), control group (n=30). All intervention was continued 5 minutes before the heel blood collection and continued until the 5th minute after the procedure. The mother called her baby between 40 and 60 decibels loudness for group 1. Breast milk was dripped onto the gauze in an amount to wet the entire 2,5cm*2,5cm sterile gauze and the gauze was then placed close to the baby's nose wings for group 2. Skin-to-skin contact between mother and baby is provided for group 3. NIPS score was saved in 5 minutes before the heel blood collection and continued until the 5th minute after the procedure for all groups.

Registry
clinicaltrials.gov
Start Date
December 22, 2022
End Date
May 15, 2023
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Istanbul University - Cerrahpasa (IUC)
Responsible Party
Principal Investigator
Principal Investigator

Elif Dogan

Principal Investigator

Istanbul University - Cerrahpasa (IUC)

Eligibility Criteria

Inclusion Criteria

  • Born between 37+0/7 - 41+6/7 gestational weeks,
  • Gestational age and birth weight are compatible,
  • Healthy newborns with stable vital signs.

Exclusion Criteria

  • Hearing problems,
  • Suction problem
  • Congenital anomaly,
  • Need hospitalization in the neonatal intensive care unit.

Outcomes

Primary Outcomes

NIPS scale

Time Frame: 5 minutes after procedure

Neonatal Infant Pain Scale (NIPS) consists of 6 items (facial expression, crying, breathing pattern, arms, legs, alertness) and is evaluated between 0-7 points in total. As the score increases, the level of pain increases.

Study Sites (1)

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