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

NCT06610656 | Completed

• 1 other identifier: ABAHAR-004
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Conditions

Pain

Keywords

white noise; pacifier; newborn; surgery

Outcome Measures

Primary Outcomes (1)

• 1. Neonatal Pain Scale (NIPS

  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.

  20 minutes

Study Arms (2)

White noise and pacifier applications group

EXPERIMENTAL

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.

Other: Pacifier and White Noise Therapy

pacifier applications group

ACTIVE COMPARATOR

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

Other: pacifier therapy

Interventions

Pacifier and White Noise Therapy OTHER

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

White noise and pacifier applications group

pacifier therapy OTHER

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

pacifier applications group

Eligibility Criteria

• Age: 1 Day - 28 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Yuksek Ihtisas University: lead

Study Sites (1)

Yüksek Ihtisas Üniversity

Ankara, Çankaya, 62510, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain

Interventions

Pacifiers

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Infant Equipment; Equipment and Supplies

Study Officials

• arzu bahar

  Yüksek Ihtisas University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: n this study, both participants and investigators are masked to the group assignment. Participants will not be aware of whether they are receiving pacifier therapy alone or in combination with white noise therapy. Investigators will not know the specific group assignments during the intervention to minimize bias in observations and assessments.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Pofessor

Model Details: 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.

Study Record Dates

• First Submitted: September 16, 2024
• First Posted: September 24, 2024
• Study Start: March 1, 2022
• Primary Completion: September 15, 2022
• Study Completion: September 15, 2022
• Last Updated: September 24, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)