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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-01

Study Completion Date

2022-09-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

The Efficacy of Non-pharmacological Interventions on Pain Levels, Crying Times and Voice Decibels in Newborns

NCT04033874

Newborn

UNKNOWN NA

Investigation of the Effect of White Noise Listening on Pain and Comfort During Invasive Interventions in Newborns

NCT05103800

Pain, Acute Child Behavior Newborn

COMPLETED NA

The Effects of Auditory Interventions on Comfort and Mothers' Anxiety in Newborns

NCT05079594

Pain, Acute

COMPLETED NA

White Noise in Nasal Cpap Application

NCT05440669

Nasal Continuous Positive Airway Pressure

COMPLETED NA

The Effect of Heart Sound and White Noise on Pain and Physiological Parameters During Hepatitis B Vaccine Injection

NCT06279169

Pain, Acute Newborn; Vitality

RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Newborn

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

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 Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type ACTIVE_COMPARATOR

white noise

Intervention Type 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.

intervention

White noise sound and pacifier implemented Group

Group Type EXPERIMENTAL

white noise

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

0 Days

Maximum Eligible Age

30 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No