Clinical trial NCT06610656: White Noise and Pacifier Use on Postoperative Pain and Crying in Newborns
Official title: The Effect of White Noise and Pacifier Applications on Pain and Crying Time in Newborns in the Postoperative Period
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Keywords: white noise
pacifier
newborn
surgery
Lead sponsor: Yuksek Ihtisas University
Sponsor class: OTHER
First posted: 2024-09-24
Enrollment: 30
Sex: ALL
Minimum age (years): 1
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study uses a parallel assignment design in which participants are assigned to one of two intervention groups. Group 1 will receive pacifier and white noise therapy, while Group 2 will receive pacifier therapy only. Each group will be treated independently, and there will be no crossover between the groups.
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: 1. Neonatal Pain Scale (NIPS
timeFrame: 20 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Yüksek Ihtisas Üniversity
state: Çankaya
Study officials:
affiliation: Yüksek Ihtisas University
name: arzu bahar
role: PRINCIPAL_INVESTIGATOR
References: