Clinical trial NCT06535061: The Effect of White Noise and Pacifier Applications on Pain and Crying Time
Official title: The Effect of White Noise and Pacifier Applications on Pain and Crying Time in Newborns in the Postoperative Period
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Newborn
Keywords: White Noise
Pain
Crying Time
Newborn
Lead sponsor: Sanko University
Sponsor class: OTHER
First posted: 2024-08-02
Enrollment: 60
Sex: ALL
Minimum age (years): 0
Maximum age (years): 30
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: 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).
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Neonatal Pain Scale
timeFrame: a day
Secondary outcomes:
measure: Neonatal Physiological Evaluation Form
timeFrame: a day
Other outcomes:
Locations:
city: Şehitkamil
country: Turkey
facility: Ebru Karaaslan
state: Gazi̇antep
Study officials:
References: