Kangaroo Care Reduces Infant Pain Caused By Vaccination

October 15, 2020 updated by: DENİZ YİĞİT, Eskisehir Osmangazi University
The aim of this randomized controlled study determine the effect of KMC on pain in infants during vaccination.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Infants undergo many painful procedures from the time they are born. Kangaroo mother care (KMC) is one of the nonpharmacological methods that are effective in alleviating pain. The aim of this randomized controlled study determine the effect of KMC on pain in infants during vaccination. The study subjects were 128 healthy, 1-month-old infants and their mothers. A sociodemographic questionnaire, the Neonatal Infant Pain Scale (NIPS), a pulse oximeter, and a chronometer were used in collecting the data. This study indicate that KMC reduced crying duration, heart rate, and pain in vaccinated infants, whereas it increased oxygen saturation levels in the blood.

Study Type

Interventional

Enrollment (Actual)

128

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 minute to 1 month (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • The consent of the parents to participate in the application of the study,
  • The infant being 1 month old
  • Parents and infants being healthy

Exclusion Criteria:

  • The consent of the parents not to participate in the application of the study,
  • The infant not being 1 month old
  • The parents and infants not being healthy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: İnfant pain management
Kangaroo mother care was applied to the infants during heel prick. With kangaroo mother care, the pain of infants was reduced.
Behavioral: İnfant pain management
Kangaroo mother care was applied to the infants during heel prick. With kangaroo mother care, the pain of infants was reduced.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain control of infants
Time Frame: during 5 minutes
The infant's pain was reduced by applying kangaroo mother care during the heel blood collection of infants.Pain level was determined with the pain scale. Pain score decreased at the end of the application.
during 5 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reduce crying time of infants
Time Frame: during 5 minutes
Crying time of infants decreased with kangaroo mother care applied during heel prick.
during 5 minutes
Control heart rate of infants
Time Frame: during 5 minutes
With kangaroo mother care applied during the heel prick, the heart rate of the babies was kept under control.
during 5 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eskisehir Osmangazi University

Investigators

  • Principal Investigator: Deniz YİĞİT, Res.Asst., ESOGU

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 1, 2016

Primary Completion (ACTUAL)

January 1, 2017

Study Completion (ACTUAL)

June 15, 2017

Study Registration Dates

First Submitted

October 8, 2020

First Submitted That Met QC Criteria

October 15, 2020

First Posted (ACTUAL)

October 22, 2020

Study Record Updates

Last Update Posted (ACTUAL)

October 22, 2020

Last Update Submitted That Met QC Criteria

October 15, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • DYIGIT2
  • Emel SEZICI (OTHER: Kütahya Health Sciences University)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Other researchers can access the entire article.

IPD Sharing Time Frame

They can reach constantly

IPD Sharing Access Criteria

Being a healthcare professional working with infants

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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