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Completed

NCT Number: NCT06610656

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

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

Completed

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Key information

Age range

1 day–28 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yüksek Ihtisas Üniversity

Ankara, Çankaya, 62510, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pacifier and White Noise Therapy

Other

Infants will receive both pacifier and white noise therapy to enhance sleep quality and reduce restlessness

pacifier therapy

Other

Infants will receive pacifier therapy to enhance sleep quality and reduce restlessness

Primary outcomes

  1. 1. Neonatal Pain Scale (NIPS

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Yuksek Ihtisas University

Other

Registry information

Official study title

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

Acronym: CLİNİCAL

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Sep 24, 2024
Registry last updated
Sep 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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