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Clinical Trials/NCT06350084
NCT06350084
Completed
N/A

The Effect of Mother's Touch and Nurse's Therapeutic Touch on Pain Level and Crying Time During Heel Blood Collection in Newborns: A Randomized Controlled Study

Burdur Mehmet Akif Ersoy University1 site in 1 country120 target enrollmentSeptember 4, 2023

Overview

Phase
N/A
Intervention
Not specified
Conditions
Pain, Acute
Sponsor
Burdur Mehmet Akif Ersoy University
Enrollment
120
Locations
1
Primary Endpoint
NIPS (Neonatal Infant Pain Scale)
Status
Completed
Last Updated
9 months ago

Overview

Brief Summary

This prospective study is planned as a randomized controlled study with the purpose of determining the effect of Mother's Touch and Nurse's Therapeutic Touch on pain levels and crying times by newborns during heel blood collection.

Detailed Description

Among the non-pharmacological methods frequently used to reduce the effects of invasive interventions on the newborn; Practices such as reducing environmental stimuli, individualized developmental care, music therapy, breast milk, pacifier giving, sucrose, non-nutritive sucking, oral sucrose, kangaroo care, facilitated tucking position, and sweet solutions, massage and touching, positioning, nesting, kangaroo care, fetal positioning are included. This study is a prospective, randomized and controlled trial. In this study aim, the effect of Mother's Touch and Nurse's Therapeutic Touch applied during heel blood collection on the pain levels and crying times in newborns will be examined. Sample of the study consisted of a total of 120 newborns who met the sample selection criteria and were selected via randomization method. Newborns were divided into three groups; Mother's Touch group, Nurse's Therapeutic Touch group, and Control group. Data were collected using the Infant-family Information Form, NIPS-Neonatal Infant Pain Scale, and Crying Follow-up Form.

Registry
clinicaltrials.gov
Start Date
September 4, 2023
End Date
February 10, 2025
Last Updated
9 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Burdur Mehmet Akif Ersoy University
Responsible Party
Principal Investigator
Principal Investigator

Selda Ateş Beşirik

Principal Investigator

Burdur Mehmet Akif Ersoy University

Eligibility Criteria

Inclusion Criteria

  • Parents who volunteered and gave consent to participate in the research
  • Full term neonates (38-42 weeks of gestation)
  • Underwent heel stick blood drawing for routine metabolic screening
  • Aged 1 to 4 days
  • Passed the hearing screening
  • Birth weight between 2500-4400 grams
  • Parents who know how to read, write and speak Turkish.

Exclusion Criteria

  • Parents with any mental problems
  • Infants with any chronic disease and congenital anomalies.

Outcomes

Primary Outcomes

NIPS (Neonatal Infant Pain Scale)

Time Frame: during the heel blood collection procedures (10 minutes)

It was developed in 1993 to evaluate interventional pain in newborns. Its Turkish adaptation was made in 1999. NIPS is an assessment tool that focuses on six behavioral responses of newborns: facial expressions, crying, breathing, arm movements, leg movements, and arousal. A score between 0 and 7 is obtained from the scale, and as the score obtained from the scale increases, the pain of newborns also increases. In the Turkish adaptation study of the scale, the Cronbach's alpha value was calculated as 0.83 before the procedure, 0.83 during the procedure and 0.86 after the procedure.

Secondary Outcomes

  • Crying times(during the heel blood collection procedures (average 10 minutes))
  • Processing time(during the heel blood collection procedures (average 10 minutes))

Study Sites (1)

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