White Noise in Nasal Cpap Application

NCT05440669 | Completed

• 1 other identifier: B.30.2.ATA.0.01.00/448
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to determine the effect of white noise application on the pain and stress level of newborns receiving oxygen support via nasal CPAP in the Neonatal Intensive Care Unit. The research is a randomized controlled trial. The population of the study will be infants aged 0-28 days who were hospitalized for treatment in Şanlıurfa Training and Research Hospital between July and December 2022. The research sample; Babies of families who are hospitalized in the Neonatal Intensive Care Unit on the specified dates and meet the research criteria and volunteer to participate in the research will be formed. "Survey Form", "Follow-up Form" and "ALPS Neo Neonatal Pain and Stress Assessment Scale", White Noise, MP 3 Player, and Sound Decibel Measuring Device will be used to collect data.

Conditions

Nasal Continuous Positive Airway Pressure

Outcome Measures

Primary Outcomes (1)

• ALPS Neo Neonatal Pain and Stress Rating Scale

  The "ALPS Neo Neonatal Pain and Stress Rating Scale" was developed in 2014, based on the individualized developmental care of the newborn, in order to evaluate pain and stress in premature and term newborns. In 2017, this scale was adapted to Turkish and its validity and reliability study was conducted. The scale is a 3-point Likert-type scale consisting of 5 parameters: "newborn's facial expression, breathing pattern, tone of the extremities, hand/foot activities, and activity level". As the scores increase, pain and stress increase in the newborn. As a result of the evaluation, "3-5 points indicate the presence of mild pain and stress, and more than 5 points indicate the presence of severe pain and stress".

  9 MONTHS

Study Arms (2)

White Noise

EXPERIMENTAL

white noise will reduce pain and stress

Behavioral: white noise

control

NO INTERVENTION

white noise will not reduce pain and stress

Interventions

white noise BEHAVIORAL

white noise will reduce pain and stress in nasal cpap application

White Noise

Eligibility Criteria

• Age: 38 Weeks - 40 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• weeks of gestation
• Receiving oxygen support in nasal CPAP
• Not taking opioids or sedatives 4 hours before the procedure

You may not qualify if:

• Not at 38-40 weeks of gestation
• Not receiving oxygen support in nasal CPAP
• Taking opioids or sedatives 4 hours before the procedure

Sponsors & Collaborators

• Ataturk University: lead

Study Sites (1)

Ataturk University Nursing of Faculty

Erzurum, Center, 25240, Turkey (Türkiye)

Location

Related Publications (1)

• Gokturk G, Sarialioglu A. Effect of white noise during nasal continuous positive airway pressure application on newborn's pain and stress levels, physiological parameters, and crying durations: A randomized controlled study. J Pediatr Nurs. 2024 Sep-Oct;78:e330-e337. doi: 10.1016/j.pedn.2024.07.022. Epub 2024 Jul 26.

  PMID: 39060170 DERIVED

Study Officials

• ARZU SARIALİOĞLU, PHD

  Ataturk University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 22, 2022
• First Posted: July 1, 2022
• Study Start: June 19, 2022
• Primary Completion: September 27, 2022
• Study Completion: January 19, 2024
• Last Updated: March 8, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)