Kangaroo Care Reduces Infant Pain Caused By Vaccination

NCT ID: NCT04596137

Last Updated: 2020-10-22

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

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

128 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-01

Study Completion Date

2017-06-15

Brief Summary

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

Detailed Description

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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.

Conditions

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Infant Pain Kangaroo Mother Care Nursing Evidence-based Practices

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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 Study Purpose

PREVENTION

Blinding Strategy

NONE

Researchers and family of infants knew about all the details of the study. Verbal and written permission was obtained from families.

Study Groups

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İnfant pain management

Kangaroo mother care was applied to the infants during heel prick. With kangaroo mother care, the pain of infants was reduced.

Group Type EXPERIMENTAL

İnfant pain management

Intervention Type BEHAVIORAL

Kangaroo mother care was applied to the infants during heel prick. With kangaroo mother care, the pain of infants was reduced.

Interventions

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İnfant pain management

Kangaroo mother care was applied to the infants during heel prick. With kangaroo mother care, the pain of infants was reduced.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

1 Minute

Maximum Eligible Age

30 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Eskisehir Osmangazi University

OTHER

Sponsor Role lead

Responsible Party

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DENİZ YİĞİT

Research Assistant

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Deniz YİĞİT, Res.Asst.

Role: PRINCIPAL_INVESTIGATOR

ESOGÜ

References

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Buyukgonenc L, Toruner EK. Pain and nursing management in childhood. In: Conk Z, Başbakkal Z, Bal Yılmaz H, Bolışık B, eds. Pediatric Nursing (pp.881-889). Ankara: Academician Bookstore; 2013.

Reference Type RESULT

Johnston C, Campbell-Yeo M, Fernandes A, Inglis D, Streiner D, Zee R. Skin-to-skin care for procedural pain in neonates. Cochrane Database Syst Rev. 2014 Jan 23;(1):CD008435. doi: 10.1002/14651858.CD008435.pub2.

Reference Type RESULT
PMID: 24459000 (View on PubMed)

Kostandy R, Anderson GC, Good M. Skin-to-skin contact diminishes pain from hepatitis B vaccine injection in healthy full-term neonates. Neonatal Netw. 2013 Jul-Aug;32(4):274-80. doi: 10.1891/0730-0832.32.4.274.

Reference Type RESULT
PMID: 23835546 (View on PubMed)

Witt N, Coynor S, Edwards C, Bradshaw H. A Guide to Pain Assessment and Management in the Neonate. Curr Emerg Hosp Med Rep. 2016;4:1-10. doi: 10.1007/s40138-016-0089-y. Epub 2016 Mar 12.

Reference Type RESULT
PMID: 27073748 (View on PubMed)

Choudhary M, Dogiyal H, Sharma D, Datt Gupta B, Madabhavi I, Choudhary JS, Choudhary SK. To study the effect of Kangaroo Mother Care on pain response in preterm neonates and to determine the behavioral and physiological responses to painful stimuli in preterm neonates: a study from western Rajasthan. J Matern Fetal Neonatal Med. 2016 Mar;29(5):826-31. doi: 10.3109/14767058.2015.1020419. Epub 2015 Mar 18.

Reference Type RESULT
PMID: 25758623 (View on PubMed)

Hartley KA, Miller CS, Gephart SM. Facilitated tucking to reduce pain in neonates: evidence for best practice. Adv Neonatal Care. 2015 Jun;15(3):201-8. doi: 10.1097/ANC.0000000000000193.

Reference Type RESULT
PMID: 26002861 (View on PubMed)

Asadi-Noghabi F, Tavassoli-Farahi M, Yousefi H, Sadeghi T. Neonate pain management: what do nurses really know? Glob J Health Sci. 2014 Jul 14;6(5):284-93. doi: 10.5539/gjhs.v6n5p284.

Reference Type RESULT
PMID: 25168978 (View on PubMed)

Conde-Agudelo A, Diaz-Rossello JL. Kangaroo mother care to reduce morbidity and mortality in low birthweight infants. Cochrane Database Syst Rev. 2016 Aug 23;2016(8):CD002771. doi: 10.1002/14651858.CD002771.pub4.

Reference Type RESULT
PMID: 27552521 (View on PubMed)

Moore ER, Bergman N, Anderson GC, Medley N. Early skin-to-skin contact for mothers and their healthy newborn infants. Cochrane Database Syst Rev. 2016 Nov 25;11(11):CD003519. doi: 10.1002/14651858.CD003519.pub4.

Reference Type RESULT
PMID: 27885658 (View on PubMed)

Cho ES, Kim SJ, Kwon MS, Cho H, Kim EH, Jun EM, Lee S. The Effects of Kangaroo Care in the Neonatal Intensive Care Unit on the Physiological Functions of Preterm Infants, Maternal-Infant Attachment, and Maternal Stress. J Pediatr Nurs. 2016 Jul-Aug;31(4):430-8. doi: 10.1016/j.pedn.2016.02.007. Epub 2016 Mar 11.

Reference Type RESULT
PMID: 26975461 (View on PubMed)

Kostandy RR, Ludington-Hoe SM. Clustered pain procedures in skin-to-skin contact (ssc) position for full term newborns. World. 2017;7:38-47. Doi: 10.4236/wjns.2017.71004.

Reference Type RESULT

Bera A, Ghosh J, Singh AK, Hazra A, Som T, Munian D. Effect of kangaroo mother care on vital physiological parameters of the low birth weight newborn. Indian J Community Med. 2014 Oct;39(4):245-9. doi: 10.4103/0970-0218.143030.

Reference Type RESULT
PMID: 25364150 (View on PubMed)

Sutar R, Baraha S, Mummidi PS. Effects of kangaroo mother care on common vital parameters of preterm infants. Int J Sci Res. 2015;4(12):373-375.

Reference Type RESULT

World Health Organization (WHO) (2003). Kangaroo mother care: A practical guide. Available at https://www.who.int/maternal_child_adolescent/documents/9241590351/en/. Accessed February 18, 2019.

Reference Type RESULT

Saeidi R, Asnaashari Z, Amirnejad M, Esmaeili H, Robatsangi MG. Use of "kangaroo care" to alleviate the intensity of vaccination pain in newborns. Iran J Pediatr. 2011 Mar;21(1):99-102.

Reference Type RESULT
PMID: 23056772 (View on PubMed)

Lawrence J, Alcock D, McGrath P, Kay J, MacMurray SB, Dulberg C. The development of a tool to assess neonatal pain. Neonatal Netw. 1993 Sep;12(6):59-66.

Reference Type RESULT
PMID: 8413140 (View on PubMed)

Akdovan T, Yıldırım, Z. Assessment of pain in healthy neonates, investigation of the effects of pacifying and holding in the arms [master dissertation]. Istanbul: Health Sciences Institute; 1999.

Reference Type RESULT

Akyurek B, Conk Z. 2006. Examining the effectiveness of nonpharmacological pain-reducing methods in newborns during needle-based procedures. J Ege Univ Sch Nurs. 2006;22(1):1-17.

Reference Type RESULT

Okan F, Ozdil A, Bulbul A, Yapici Z, Nuhoglu A. Analgesic effects of skin-to-skin contact and breastfeeding in procedural pain in healthy term neonates. Ann Trop Paediatr. 2010;30(2):119-28. doi: 10.1179/146532810X12703902516121.

Reference Type RESULT
PMID: 20522298 (View on PubMed)

Gray L, Watt L, Blass EM. Skin-to-skin contact is analgesic in healthy newborns. Pediatrics. 2000 Jan;105(1):e14. doi: 10.1542/peds.105.1.e14.

Reference Type RESULT
PMID: 10617751 (View on PubMed)

Nimbalkar SM, Chaudhary NS, Gadhavi KV, Phatak A. Kangaroo Mother Care in reducing pain in preterm neonates on heel prick. Indian J Pediatr. 2013 Jan;80(1):6-10. doi: 10.1007/s12098-012-0760-6. Epub 2012 Apr 28.

Reference Type RESULT
PMID: 22544676 (View on PubMed)

Kashaninia Z, Sajedi F, Rahgozar M, Noghabi FA. The effect of Kangaroo Care on behavioral responses to pain of an intramuscular injection in neonates. J Spec Pediatr Nurs. 2008 Oct;13(4):275-80. doi: 10.1111/j.1744-6155.2008.00165.x.

Reference Type RESULT
PMID: 19238715 (View on PubMed)

Dezhdar S, Jahanpour F, Firouz Bakht S, Ostovar A. The Effects of Kangaroo Mother Care and Swaddling on Venipuncture Pain in Premature Neonates: A Randomized Clinical Trial. Iran Red Crescent Med J. 2016 Feb 21;18(4):e29649. doi: 10.5812/ircmj.29649. eCollection 2016 Apr.

Reference Type RESULT
PMID: 27274399 (View on PubMed)

Stuard W. The effects of kangaroo care on a newborn development and vital physiology. Clin Mother Child Health. 2016;13(1):1-4. Doi: 10.4172/2090-7214.1000225.

Reference Type RESULT

Moore ER, Anderson GC, Bergman N, Dowswell T. Early skin-to-skin contact for mothers and their healthy newborn infants. Cochrane Database Syst Rev. 2012 May 16;5(5):CD003519. doi: 10.1002/14651858.CD003519.pub3.

Reference Type RESULT
PMID: 22592691 (View on PubMed)

Other Identifiers

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Emel SEZICI

Identifier Type: OTHER

Identifier Source: secondary_id

DYIGIT2

Identifier Type: -

Identifier Source: org_study_id

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