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InfantNCT04596137

Kangaroo Care Reduces Infant Pain Caused By Vaccination

A study testing İnfant pain management in people with Infant and Pain, run by Eskisehir Osmangazi University.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 1 minute to 30 daysHealthy volunteers can take part
Conditions the study is for
Infant, Pain, Kangaroo Mother Care
What is being tested?
İnfant pain management
Could I receive a placebo?
No, everyone receives an active treatment
How many people
128 participants
Where
No sites listed yet
Study dates
1 Jun 2016to 15 Jun 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 1 minute to 30 days
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

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

Who cannot join

  • 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.

About this study

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

Read the 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.

Being tested
İnfant pain management
Keywords
infant, pain, kangaroo mother care, nursing, evidence-based practices
Medical subject headings
Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • İnfant pain managementBehavioural

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

Study groups in NCT04596137
Study groupRoleWhat they receive
İnfant pain managementExperimentalKangaroo mother care was applied to the infants during heel prick. With kangaroo mother care, the pain of infants was reduced.
Receives: Behavioral: İnfant pain management

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: during 5 minutes

Secondary outcomes (2)

  1. Reduce crying time of infants

    Crying time of infants decreased with kangaroo mother care applied during heel prick.

    Measured: during 5 minutes

  2. Control heart rate of infants

    With kangaroo mother care applied during the heel prick, the heart rate of the babies was kept under control.

    Measured: during 5 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Oct 2020
  2. Study start1 Jun 2016
  3. Primary completion1 Jan 2017
  4. Study completion15 Jun 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
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.
Masking
None (open label)
Enrolment
128 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04596137
Sponsor's protocol ID
DYIGIT2
Other IDs
Emel SEZICI
Status last verified
Oct 2020
First submitted
8 Oct 2020
Last updated
22 Oct 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Other researchers can access the entire article.

Publications

  • 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.

  • 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.

    PubMed 24459000

  • 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.

    PubMed 23835546

  • 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.

    PubMed 27073748

  • 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.

    PubMed 25758623

  • 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.

    PubMed 26002861

  • 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.

    PubMed 25168978

  • 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.

    PubMed 27552521

  • 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.

    PubMed 27885658

  • 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.

    PubMed 26975461

  • 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.

  • 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.

    PubMed 25364150

  • 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.

  • 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.

  • 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.

    PubMed 23056772

Questions about this trial

What is this clinical trial studying?

A study testing İnfant pain management in people with Infant and Pain, run by Eskisehir Osmangazi University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain control of infants (time frame: during 5 minutes). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04596137, which also lists 25 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2020.

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