Clinical trial NCT04596137: Kangaroo Care Reduces Infant Pain Caused By Vaccination
Official title: Kangaroo Care Reduces Infant Pain Caused By Vaccination
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infant
Pain
Kangaroo Mother Care
Nursing
Evidence-based Practices
Keywords: infant
pain
kangaroo mother care
nursing
evidence-based practices
Lead sponsor: Eskisehir Osmangazi University
Sponsor class: OTHER
First posted: 2020-10-22
Enrollment: 128
Sex: ALL
Minimum age (years): 1
Maximum age (years): 30
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The study was conducted between May -September 2016 in FHC. As 1-month-old infants were enrolled for the study, the total number of infants enrolled in FHCs each month was determined. Post-natal infants numbers were recorded in May-June, June-July, July-August, and August-September, for 48, 52, 59, and 57 infants, respectively. A pilot study was conducted on 20 infants born in May. Following the pilot study, monthly randomization was performed by an investigator. Accordingly, the study and control groups were determined monthly. There was no blinding in this study.
Primary purpose: PREVENTION

Brief summary: The aim of this randomized controlled study determine the effect of KMC on pain in infants during vaccination.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Pain control of infants
timeFrame: during 5 minutes
Secondary outcomes:
measure: Reduce crying time of infants
timeFrame: during 5 minutes
measure: Control heart rate of infants
timeFrame: during 5 minutes
Other outcomes:
Locations:
Study officials:
affiliation: ESOGÜ
name: Deniz YİĞİT, Res.Asst.
role: PRINCIPAL_INVESTIGATOR
References:
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