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

NCT ID: NCT06610656

Last Updated: 2024-09-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-01
• Study Completion Date: 2022-09-15

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.

Conditions

Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

White noise and pacifier applications group

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.

Group Type: EXPERIMENTAL

Pacifier and White Noise Therapy

Intervention Type: OTHER

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

pacifier applications group

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

Group Type: ACTIVE_COMPARATOR

pacifier therapy

Intervention Type: OTHER

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

Interventions

Pacifier and White Noise Therapy

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

Intervention Type: OTHER

pacifier therapy

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 1 Day
• Maximum Eligible Age: 28 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yuksek Ihtisas University

OTHER

Sponsor Role: lead

Responsible Party

Arzu Bahar

Associate Pofessor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

arzu bahar

Role: PRINCIPAL_INVESTIGATOR

Yüksek Ihtisas University

Locations

Yüksek Ihtisas Üniversity

Ankara, Çankaya, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

ABAHAR-004

Identifier Type: -

Identifier Source: org_study_id