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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04596137
Other study ID # DYIGIT2
Secondary ID Emel SEZICI
Status Completed
Phase N/A
First received
Last updated
Start date June 1, 2016
Est. completion date June 15, 2017

Study information

Verified date October 2020
Source Eskisehir Osmangazi University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 128
Est. completion date June 15, 2017
Est. primary completion date January 1, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A to 30 Days
Eligibility 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 Design


Intervention

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

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Eskisehir Osmangazi University

References & Publications (25)

Akdovan T, Yildirim, 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.

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.

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. — View Citation

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. — View Citation

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

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): — View Citation

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 pre — View Citation

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

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. eCol — View Citation

Gray L, Watt L, Blass EM. Skin-to-skin contact is analgesic in healthy newborns. Pediatrics. 2000 Jan;105(1):e14. — View Citation

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. Review. — View Citation

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. Review. Update in: Cochrane Database Syst R — View Citation

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. — View Citation

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. — View Citation

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.

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. — View Citation

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):CD003519. doi: 10.1002/14651858.CD003519.pub3. Review. Update in: Cochrane Database Syst Re — View Citation

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:CD003519. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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.

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.

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. Epub 2016 Mar 12. Review. — View Citation

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.

* Note: There are 25 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Reduce crying time of infants Crying time of infants decreased with kangaroo mother care applied during heel prick. during 5 minutes
Secondary Control heart rate of infants With kangaroo mother care applied during the heel prick, the heart rate of the babies was kept under control. during 5 minutes
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