Skip to main content
Clinical Trials/NCT04625010
NCT04625010CompletedNot Applicable

The Effectiveness of Two Different Methods Applied During Heel Blood Collection on Pain Level of Healthy Term Newborns

Istanbul University - Cerrahpasa2 sites in 2 countries105 target enrollmentStarted: March 1, 2016Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
105
Locations
2
Primary Endpoint
NIPS (Neonatal Infant Pain Scale)

Study Overview

Brief Summary

This study was planned to evaluate the effect of two different non-pharmacologic pain relief methods (swaddling and maternal holding) on healthy term newborn's pain levels during heel stick.

Study hypotheses are; Hypothesis 1. Swaddling is effective at relieving pain due to heel stick procedures in newborns. Hypothesis 2. Maternal holding is effective at relieving pain due to heel stick in newborns. Hypothesis 3. Maternal holding is more effective than swaddling at relieving pain due to heel stick in newborns.

Detailed Description

This study was conducted in the baby's nursery of Bandirma State Hospital, Turkey between March and June 2016. It was designed as a prospective randomized clinical trial that evaluated and experimentally determined the effects of swaddling and maternal holding during heel stick on pain levels in healthy term neonates.

The study comprised all newborns who came to the baby's nursery for a heel stick procedure for routine metabolic screening; the study sample consisted of 105 healthy newborns who matched the case selection criteria and underwent heel stick. The inclusion criteria were as follows: full term neonates (38-42 weeks of gestation) who underwent heel stick blood drawing for routine metabolic screening, were aged 2 to 4 days, and had passed the hearing screening. Babies with congenital anomalies were excluded from the study.

In the power analysis conducted using heel stick literature1,4,9, the sample size required for 80% reliability and α=0.05 was 35 in each group; the total was 105. Neonates were randomized into three groups and 35 babies were evaluated in each group (swaddling [n=35], maternal holding [n=35], control [n=35]) (Figure 1). Numbers from 1-105 were randomly distributed by a computer program to the three groups with no number repetition to determine which child would be allocated to which group.

The study data were obtained using an information form and the Neonatal Infant Pain Scale (NIPS).

Information Form: This form contained questions about the sociodemographic characteristics of the neonate and family. It consisted of 20 questions in total comprising personal characteristics information of the families, and sex, delivery method (vaginal or cesarean), gestational age, birth weight, postnatal age (hours after birth) of the neonate and period of procedures.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
None

Eligibility Criteria

Ages
2 Days to 4 Days (Child)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • full term neonates (38-42 weeks of gestation)
  • underwent heel stick blood drawing for routine metabolic screening,
  • aged 2 to 4 days
  • passed the hearing screening

Exclusion Criteria

  • Congenital anomalies

Outcomes

Primary Outcomes

NIPS (Neonatal Infant Pain Scale)

Time Frame: Pain levels of the newborns evaluated during the procedures

Neonatal Infant Pain Scale: NIPS was developed by Lawrence et al. (1993)21 to evaluate behavioral and physiologic pain responses of preterm and term infants. The scale was adapted to Turkish by Akdovan (1999)22. In the present study, NIPS was used to evaluate the interventional (procedural) pain level of newborns. The scale consists of five behavioral (facial expressions, crying, wakefulness, arm and leg movements) and a physiologic (breathing) signs; 0-2 points are given to the crying indicator, 0-1 points are given to other indicators, and the total score is between 0 and 7. High scores indicate that the severity of pain is excessive.

Secondary Outcomes

  • Total criying time(The time of the procedure was measured from the beginning to the end of the heel stick procedure.)
  • The time to first calming(Procedure (The calming time was measured from the time of the first cry to the first calming time.))

Investigators

Sponsor
Istanbul University - Cerrahpasa
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Sevil Inal

Prof. Dr.

Istanbul University - Cerrahpasa

Study Sites (2)

Loading locations...

Similar Trials