Kangaroo Care Reduces Infant Pain Caused By Vaccination

NCT04596137 | Completed

• 2 other identifiers: DYIGIT2Emel SEZICI
• Study Type: interventional
• Target: 128
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Infant; Pain; Kangaroo Mother Care; Nursing; Evidence-based Practices

Keywords

infant; pain; kangaroo mother care; nursing; evidence-based practices

Outcome Measures

Primary Outcomes (1)

• Pain control of infants

  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 Outcomes (2)

• Reduce crying time of infants

  during 5 minutes

• Control heart rate of infants

  during 5 minutes

Study Arms (1)

İnfant pain management

EXPERIMENTAL

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

Interventions

İnfant pain management BEHAVIORAL

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

İnfant pain management

Eligibility Criteria

• Age: 1 Minute - 30 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eskisehir Osmangazi University: lead

Related Publications (25)

• 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.

  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.

  PMID: 24459000 RESULT

• 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.

  PMID: 23835546 RESULT

• 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.

  PMID: 27073748 RESULT

• 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.

  PMID: 25758623 RESULT

• 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.

  PMID: 26002861 RESULT

• 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.

  PMID: 25168978 RESULT

• 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.

  PMID: 27552521 RESULT

• 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.

  PMID: 27885658 RESULT

• 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.

  PMID: 26975461 RESULT

• 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.

  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.

  PMID: 25364150 RESULT

• 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.

  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.

  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.

  PMID: 23056772 RESULT

• 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.

  PMID: 8413140 RESULT

• 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.

  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.

  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.

  PMID: 20522298 RESULT

• 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.

  PMID: 10617751 RESULT

• 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.

  PMID: 22544676 RESULT

• 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.

  PMID: 19238715 RESULT

• 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.

  PMID: 27274399 RESULT

• 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.

  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.

  PMID: 22592691 RESULT

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Deniz YİĞİT, Res.Asst.

  ESOGÜ

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Researchers and family of infants knew about all the details of the study. Verbal and written permission was obtained from families.
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Model Details: 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.

Study Record Dates

• First Submitted: October 8, 2020
• First Posted: October 22, 2020
• Study Start: June 1, 2016
• Primary Completion: January 1, 2017
• Study Completion: June 15, 2017
• Last Updated: October 22, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: They can reach constantly
• Access Criteria: Being a healthcare professional working with infants