Effect of Three Different Sensory Interventions on Pain Level During Heel Blood Collection in Term Infant
NCT ID: NCT05526378
Last Updated: 2024-10-18
Study Results
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Basic Information
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COMPLETED
NA
120 participants
INTERVENTIONAL
2022-12-22
2023-05-15
Brief Summary
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Method: The population of the study consisted of babies who were hospitalized in a hospital's neonatal unit between December 2022 and May 2023 and who heel blood taken. The Neonatal-Infant Pain (NIPS) Scale and data collection form were used to obtain the data. 120 newborns who met the study criteria were randomly divided into group 1 (n=30) , group 2 (n=30), group 3 (n=30), control group (n=30). All intervention was continued 5 minutes before the heel blood collection and continued until the 5th minute after the procedure. The mother called her baby between 40 and 60 decibels loudness for group 1. Breast milk was dripped onto the gauze in an amount to wet the entire 2,5cm\*2,5cm sterile gauze and the gauze was then placed close to the baby's nose wings for group 2. Skin-to-skin contact between mother and baby is provided for group 3. NIPS score was saved in 5 minutes before the heel blood collection and continued until the 5th minute after the procedure for all groups.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
TRIPLE
Study Groups
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Group 1 (mother's voice)
The mother called her baby between 40 and 60 decibels loudness. The intervention was continued 5 minutes before the heel blood collection and continued until the 5th minute after the procedure. NIPS score was saved in 5 minutes before the heel blood collection and continued until the 5th minute after the procedure.
Benetech brand GM1352 model decibel meter was used to measure the loudness.
Sensory Interventions
Group 1 will be hear mother's voice before, during and after the procedure. Group 2 will be sniffed mother's breast milk before, during and after the procedure.
Group 3 will be skin contact with mother's before, during and after the procedure.
Group 2 (mother's milk)
Breast milk was dripped onto the gauze in an amount to wet the entire 2,5cm\*2,5cm sterile gauze. The gauze was then placed close to the baby's nose wings. The intervention was continued 5 minutes before the heel blood collection and continued until the 5th minute after the procedure. NIPS score was saved in 5 minutes before the heel blood collection and continued until the 5th minute after the procedure
Sensory Interventions
Group 1 will be hear mother's voice before, during and after the procedure. Group 2 will be sniffed mother's breast milk before, during and after the procedure.
Group 3 will be skin contact with mother's before, during and after the procedure.
Group 3 (skin to skin contact)
Skin-to-skin contact between mother and baby is provided. The intervention was continued 5 minutes before the heel blood collection and continued until the 5th minute after the procedure. NIPS score was saved in 5 minutes before the heel blood collection and continued until the 5th minute after the procedure
Sensory Interventions
Group 1 will be hear mother's voice before, during and after the procedure. Group 2 will be sniffed mother's breast milk before, during and after the procedure.
Group 3 will be skin contact with mother's before, during and after the procedure.
Control group
No interventions assigned to this group
Interventions
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Sensory Interventions
Group 1 will be hear mother's voice before, during and after the procedure. Group 2 will be sniffed mother's breast milk before, during and after the procedure.
Group 3 will be skin contact with mother's before, during and after the procedure.
Eligibility Criteria
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Inclusion Criteria
* Gestational age and birth weight are compatible,
* Healthy newborns with stable vital signs.
Exclusion Criteria
* Suction problem
* Congenital anomaly,
* Need hospitalization in the neonatal intensive care unit.
24 Hours
48 Hours
ALL
Yes
Sponsors
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Istanbul University - Cerrahpasa
OTHER
Responsible Party
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Elif Dogan
Principal Investigator
Principal Investigators
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Elif Dogan
Role: PRINCIPAL_INVESTIGATOR
Researcher Assistant
Locations
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Istanbul University Cerrahpasa
Istanbul, , Turkey (Türkiye)
Countries
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References
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Lin CH, Liaw JJ, Chen YT, Yin T, Yang L, Lan HY. Efficacy of Breast Milk Olfactory and Gustatory Interventions on Neonates' Biobehavioral Responses to Pain during Heel Prick Procedures. Int J Environ Res Public Health. 2022 Jan 22;19(3):1240. doi: 10.3390/ijerph19031240.
McPherson C, Miller SP, El-Dib M, Massaro AN, Inder TE. The influence of pain, agitation, and their management on the immature brain. Pediatr Res. 2020 Aug;88(2):168-175. doi: 10.1038/s41390-019-0744-6. Epub 2020 Jan 2.
McNair C, Campbell-Yeo M, Johnston C, Taddio A. Nonpharmacologic Management of Pain During Common Needle Puncture Procedures in Infants: Current Research Evidence and Practical Considerations: An Update. Clin Perinatol. 2019 Dec;46(4):709-730. doi: 10.1016/j.clp.2019.08.006. Epub 2019 Aug 26.
Zhang S, Su F, Li J, Chen W. The Analgesic Effects of Maternal Milk Odor on Newborns: A Meta-Analysis. Breastfeed Med. 2018 Jun;13(5):327-334. doi: 10.1089/bfm.2017.0226. Epub 2018 May 7.
Benoit B, Newman A, Martin-Misener R, Latimer M, Campbell-Yeo M. The influence of breastfeeding on cortical and bio-behavioural indicators of procedural pain in newborns: Findings of a randomized controlled trial. Early Hum Dev. 2021 Mar;154:105308. doi: 10.1016/j.earlhumdev.2021.105308. Epub 2021 Jan 12.
Kucuk Alemdar D, Kardas Ozdemir F. Effects of Having Preterm Infants Smell Amniotic Fluid, Mother's Milk, and Mother's Odor During Heel Stick Procedure on Pain, Physiological Parameters, and Crying Duration. Breastfeed Med. 2017 Jun;12:297-304. doi: 10.1089/bfm.2017.0006. Epub 2017 Apr 17.
Yilmaz D, Yilmaz Kurt F. The effect of foot reflexology on procedural pain before heel lancing in neonates. Arch Pediatr. 2021 May;28(4):278-284. doi: 10.1016/j.arcped.2021.02.015. Epub 2021 Mar 11.
Filippa M, Devouche E, Arioni C, Imberty M, Gratier M. Live maternal speech and singing have beneficial effects on hospitalized preterm infants. Acta Paediatr. 2013 Oct;102(10):1017-20. doi: 10.1111/apa.12356. Epub 2013 Aug 8.
Cakirli M, Acikgoz A. A Randomized Controlled Trial: The Effect of Own Mother's Breast Milk Odor and Another Mother's Breast Milk Odor on Pain Level of Newborn Infants. Breastfeed Med. 2021 Jan;16(1):75-81. doi: 10.1089/bfm.2020.0222. Epub 2020 Oct 20.
Filippa M, Monaci MG, Spagnuolo C, Serravalle P, Daniele R, Grandjean D. Maternal speech decreases pain scores and increases oxytocin levels in preterm infants during painful procedures. Sci Rep. 2021 Aug 27;11(1):17301. doi: 10.1038/s41598-021-96840-4.
Duman R, Dogan E, Kaya HD, Tepe M. The Effect of Three Different Sensory Interventions (Mother's Voice, Mother's Milk, and Mother's Holding) During Heel Lance on Pain Level in Term Newborns: A Randomized Controlled Trial. Breastfeed Med. 2025 May;20(5):345-352. doi: 10.1089/bfm.2024.0197. Epub 2025 Feb 7.
Other Identifiers
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2022/94
Identifier Type: -
Identifier Source: org_study_id
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