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

NCT06535061 | Completed

• 1 other identifier: SankoU-Nursing-EK-002
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Newborn

Keywords

White Noise; Pain; Crying Time; Newborn

Outcome Measures

Primary Outcomes (1)

• Neonatal Pain Scale

  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 Outcomes (1)

• Neonatal Physiological Evaluation Form

  a day

Study Arms (2)

control

ACTIVE COMPARATOR

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

intervention

EXPERIMENTAL

White noise sound and pacifier implemented Group

Other: white noise

Interventions

white noise OTHER

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.

control; intervention

Eligibility Criteria

• Age: 0 Days - 30 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

• Sanko University: lead

Study Sites (1)

Ebru Karaaslan

Şehitkamil, Gazi̇antep, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: research assistant

Model Details: After the newborns left intubation in the postoperative period, physical parameters were measured before, during, after venous blood collection, before, during, after heel blood collection, and before, during and after intravenous intervention, and were evaluated with the Neonatal Infant Pain Scale (NIPS).

Study Record Dates

• First Submitted: July 28, 2024
• First Posted: August 2, 2024
• Study Start: March 1, 2022
• Primary Completion: September 15, 2022
• Study Completion: September 15, 2022
• Last Updated: August 2, 2024

Record last verified: 2024-08

Locations

TU (1)