Skip to content

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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06610656
Acronym
CLİNİCAL
Enrollment
30
Registered
2024-09-24
Start date
2022-03-01
Completion date
2022-09-15
Last updated
2024-09-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain

Keywords

white noise, pacifier, newborn, surgery

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

Detailed description

Newborns most often experience painful procedures such as heel blood collection and peripheral venous catheter placement in the neonatal intensive care unit. Exposure to pain early in life has even been shown to increase the risk of developing problems (chronic pain, anxiety, and depressive disorders) in adulthood. This result implies that newborn or child pain should be adequately managed. Thus, pain in newborns or children should be prevented before it occurs, and if it cannot be prevented, it should be determined in the early period and the pain should be alleviated. Managing this pain in newborns should be one of the primary duties of newborn nurses. The first and most important determinant in relieving pain is determining the severity of pain, and non-pharmacological or pharmacological methods should be preferred according to the severity of the pain. Many non-pharmacological methods are used to manage pain that may occur in interventional procedures. Some of these methods are: giving sugar solution, kangaroo care, positioning (Kaşıkçıoğlu, 2014), breast milk and breastfeeding and swaddling, listening to music, lullaby. Two other effective methods are non-nutritive suction and white noise. As a result of studies, it was proven that the use of multiple non-pharmacological methods together was much more effective in reducing pain. Within the scope of the research, no research was found in the literature regarding which application - white noise or pacifier - could be more effective. By examining this information, the effects of the two effective methods on pain management and crying time in newborns in the postoperative period were examined in this study.

Interventions

OTHERPacifier and White Noise Therapy

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

OTHERpacifier therapy

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

Sponsors

Yuksek Ihtisas University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Outcomes Assessor)

Masking description

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.

Intervention model description

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.

Eligibility

Sex/Gender
ALL
Age
1 Days to 28 Days
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
1. Neonatal Pain Scale (NIPS20 minutesThe 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.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026