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Clinical Trials/NCT06535061
NCT06535061
Completed
Not Applicable

The Effect of White Noise and Pacifier Applications on Pain and Crying Time in Newborns in the Postoperative Period

Sanko University1 site in 1 country60 target enrollmentMarch 1, 2022
ConditionsNewborn

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Newborn
Sponsor
Sanko University
Enrollment
60
Locations
1
Primary Endpoint
Neonatal Pain Scale
Status
Completed
Last Updated
last year

Overview

Brief Summary

The objective of the study was to determine the effect of white noise and pacifier applications on pain and crying time in newborns during painful interventions. The research was planned experimentally. Pacifier application was applied to the newborns, who had undergone surgery, and they formed the control group. White noise and pacifier applications were applied to the newborns, who had undergone surgery, and they formed the experimental group.

Detailed Description

Data from children's hospitals around the world reveal that pain in pediatric patients from infancy to adolescence is common, under-recognized and undertreated. Compared to adult patients, pediatric patients with the same diagnosis receive fewer doses of analgesics, and the younger children are, the less likely they are to receive adequate analgesia in the medical setting. A particularly vulnerable group of patients are infants and newborns. During the day, newborns most frequently experience painful interventions such as heel prick blood collection and peripheral venous catheter placement in the neonatal intensive care unit. Within the scope of the research, no research comparing the effectiveness of white noise and pacifier applications was found in the literature review. By examining this information, the effects of two effective methods on pain management and crying time in newborns in the postoperative period were examined in this study.

Registry
clinicaltrials.gov
Start Date
March 1, 2022
End Date
September 15, 2022
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Sanko University
Responsible Party
Principal Investigator
Principal Investigator

Ebru Karaaslan

research assistant

Sanko University

Eligibility Criteria

Inclusion Criteria

  • Birth weight over 1500 grams
  • Having passed the newborn hearing screening test
  • Having a history of previous surgery (excluding brain surgeries)
  • Not using sedative substances (dormicum, fentanyl)
  • Not using opioids
  • Having a full stomach 30 minutes before painful interventions
  • Having permission from their mothers
  • Newborns undergoing blood transfusion only

Exclusion Criteria

  • Being intubated
  • Having hiberbilirubinemia
  • Birth weight below 1500 grams
  • Having cerebral palsy
  • Having hydrocephalus
  • Having spina bifida
  • Having had brain surgery

Outcomes

Primary Outcomes

Neonatal Pain Scale

Time Frame: a day

The factors evaluated in the neonatal pain scale are facial expression, arms, legs, oxygen saturation, arousal status, breathing pattern, crying, and heart rate factors. It can be preferred in post-operative pain and used for procedural pain. It has 8 parameters in total. A maximum of 7 points can be awarded: 0 points = no pain; 1-2 points = mild pain; 3-4 points = moderate pain; \>4 points = severe pain

Secondary Outcomes

  • Neonatal Physiological Evaluation Form(a day)

Study Sites (1)

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