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Completed

NCT Number: NCT06535061

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

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.

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Key information

Conditions

Newborn Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

0 day–30 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ebru Karaaslan

Şehitkamil, Gazi̇antep, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Sanko University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Aug 2, 2024
Registry last updated
Aug 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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