The Effect of White Noise and Pacifier Applications on Pain and Crying Time

August 1, 2024 updated by: Ebru Karaaslan, Sanko University

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

The objective of the study was to determine the effect of white noise and pacifier applications on pain and crying time in newborns during painful interventions. The research was planned experimentally. Pacifier application was applied to the newborns, who had undergone surgery, and they formed the control group. White noise and pacifier applications were applied to the newborns, who had undergone surgery, and they formed the experimental group.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Data from children's hospitals around the world reveal that pain in pediatric patients from infancy to adolescence is common, under-recognized and undertreated. Compared to adult patients, pediatric patients with the same diagnosis receive fewer doses of analgesics, and the younger children are, the less likely they are to receive adequate analgesia in the medical setting.

A particularly vulnerable group of patients are infants and newborns. During the day, newborns most frequently experience painful interventions such as heel prick blood collection and peripheral venous catheter placement in the neonatal intensive care unit.

Within the scope of the research, no research comparing the effectiveness of white noise and pacifier applications was found in the literature review. By examining this information, the effects of two effective methods on pain management and crying time in newborns in the postoperative period were examined in this study.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Gazi̇antep
      • Şehitkamil, Gazi̇antep, Turkey
        • Ebru Karaaslan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: control
Pacifiers suitable for the mouth diameter of all newborns were given. Heel blood was collected from the heel of the right foot of all newborns. The heel was stroked by hand before the procedure. Blood flow was accelerated.
Other: white noise
The experimental group was exposed to a white noise sound combined from 4 different sounds: ultrasound heartbeat sound, wave sound, vacuum cleaner sound and hair removal machine sound at 50 dBSPL 5 minutes before the procedure. The experimental group was exposed to white noise for a total of 15 minutes before, during and after the procedure. At the same time, the newborn in the experimental group I was given a pacifier.
Experimental: intervention
White noise sound and pacifier implemented Group
Other: white noise
The experimental group was exposed to a white noise sound combined from 4 different sounds: ultrasound heartbeat sound, wave sound, vacuum cleaner sound and hair removal machine sound at 50 dBSPL 5 minutes before the procedure. The experimental group was exposed to white noise for a total of 15 minutes before, during and after the procedure. At the same time, the newborn in the experimental group I was given a pacifier.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neonatal Pain Scale
Time Frame: a day
The factors evaluated in the neonatal pain scale are facial expression, arms, legs, oxygen saturation, arousal status, breathing pattern, crying, and heart rate factors. It can be preferred in post-operative pain and used for procedural pain. It has 8 parameters in total. A maximum of 7 points can be awarded: 0 points = no pain; 1-2 points = mild pain; 3-4 points = moderate pain; >4 points = severe pain
a day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neonatal Physiological Evaluation Form
Time Frame: a day

This form included the newborns' fever, heart rate, respiratory rate and saturation, crying time, and NIPS pain scores 5 minutes before painful interventions, during painful interventions, and 5 minutes after painful interventions. A Nimomed Non-Contact Infrared Thermometer was used to measure the temperature of the newborns. The Nihon Kohden Monitor was used to measure the newborn's heart rate and saturation.

A newborn scale was used to weigh the newborn's weight. The sound level (lower limit 200-250 Hz, upper limit 10-16 kHz) was evaluated with a Saunal Meter. The newborns were monitored with the above medical instruments. The crying time of the newborns was recorded with a voice recorder, and discussed on a minute basis. The newborn white noise sound was created by combining hair dryer, vacuum cleaner, wave sound and ultrasound device with heartbeat sound. The newborns in the experimental group listened to it for a total of 15 minutes in 5-minute periods.
a day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanko University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2022

Primary Completion (Actual)

September 15, 2022

Study Completion (Actual)

September 15, 2022

Study Registration Dates

First Submitted

July 28, 2024

First Submitted That Met QC Criteria

August 1, 2024

First Posted (Actual)

August 2, 2024

Study Record Updates

Last Update Posted (Actual)

August 2, 2024

Last Update Submitted That Met QC Criteria

August 1, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • SankoU-Nursing-EK-002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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