White Noise and Pacifier Use on Postoperative Pain and Crying in Newborns

Not Applicable

Completed

• Conditions: Pain
• Interventions: Other: Pacifier and White Noise Therapy; Other: pacifier therapy

• Registration Number: NCT06610656
• Lead Sponsor: Yuksek Ihtisas University

Brief Summary

The study was conducted to determine the effect of white noise and pacifier applications on pain and crying time during painful interventions in newborns who underwent surgery

Detailed Description

Newborns most often experience painful procedures such as heel blood collection and peripheral venous catheter placement in the neonatal intensive care unit. Exposure to pain early in life has even been shown to increase the risk of developing problems (chronic pain, anxiety, and depressive disorders) in adulthood. This result implies that newborn or child pain should be adequately managed. Thus, pain in newborns or children should be prevented before it occurs, and if it cannot be prevented, it should be determined in the early period and the pain should be alleviated. Managing this pain in newborns should be one of the primary duties of newborn nurses. The first and most important determinant in relieving pain is determining the severity of pain, and non-pharmacological or pharmacological methods should be preferred according to the severity of the pain. Many non-pharmacological methods are used to manage pain that may occur in interventional procedures. Some of these methods are: giving sugar solution, kangaroo care, positioning (Kaşıkçıoğlu, 2014), breast milk and breastfeeding and swaddling, listening to music, lullaby. Two other effective methods are non-nutritive suction and white noise. As a result of studies, it was proven that the use of multiple non-pharmacological methods together was much more effective in reducing pain. Within the scope of the research, no research was found in the literature regarding which application - white noise or pacifier - could be more effective. By examining this information, the effects of the two effective methods on pain management and crying time in newborns in the postoperative period were examined in this study.

Study Timeline

• Study Start: 2022-03-01
• Primary Completion: 2022-09-15
• Study Completion: 2022-09-15
• Status Verified: 2024-09
• Study First Submitted: 2024-09-16
• Study First Submitted QC: 2024-09-20
• Last Update Submitted: 2024-09-20
• Study First Posted: 2024-09-24
• Last Update Posted: 2024-09-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
White noise and pacifier applications group	Pacifier and White Noise Therapy	In this group, infants will receive pacifier and white noise therapy. The white noise will be used to enhance the quality of sleep and reduce restlessness in infants. During the intervention, participants will receive pacifiers, and white noise will be continuously administered.
pacifier applications group	pacifier therapy	In this group, infants will receive only pacifier therapy. The aim is to provide comfort and support for sleep through the use of pacifiers. White noise will not be utilized in this group. This intervention focuses solely on assessing the effects of pacifier use without any additional auditory stimuli

Primary Outcome Measures

Name	Time	Method
1. Neonatal Pain Scale (NIPS	20 minutes	The factors evaluated in the newborn baby pain scale are facial expression, arms, legs, oxygen saturation, arousal, breathing pattern, crying, heart rate. It can be preferred in post-operative pain. It can be used in procedural pain. It has a total of 8 parameters. The highest score can be given is 7. 0 points = no pain, 1-2 points = mild pain, 3-4 points = moderate pain, \>4 points = severe pain is accepted.

Trial Locations

Locations (1)

Yüksek Ihtisas Üniversity; 🇹🇷 Ankara, Çankaya, Turkey