Effect of Swaddling and Inhaling Breast Milk Odour on the Pain and Comfort
NCT ID: NCT06120062
Last Updated: 2023-11-07
Study Results
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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COMPLETED
120 participants
OBSERVATIONAL
2020-10-01
2023-01-13
Brief Summary
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Detailed Description
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This randomized controlled experimental study was conducted to determine the effect of swaddling and inhaling mother's breast milk odour on the pain and comfort during the placement of peripheral intravenous catheter in term infants.
The population of the study consisted of term infants hospitalized in the neonatal intensive care unit of Karadeniz Ereğli State Hospital between 1st October 2020 and 1st October 2021. According to the G-Power analysis, the sample size was calculated as 120 and term infants were equallyassigned to three experimental groups and a control group, each of which consisted of 30 infants. During the placement of peripheral intravenous catheter, the infants in the 1st experimental group were swaddled, the infants in the 2ndexperimentalgroup were made to inhale the mother's breast milk odour, the infants in the 3rd experimentalgroup were both swaddled and made to inhale the mother's breast milkodour and no procedure was applied to the infants in the control group. The pain and comfort levels of infants in the experimental and control groups were assessed before, during and after the placement of peripheral intravenous catheter."Infant Descriptive Information Form", "Neonatal Infant Pain Scale" and "Neonatal Comfort Behaviour Scale were used to collect data.
Conditions
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Study Design
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CASE_CONTROL
CROSS_SECTIONAL
Study Groups
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1st experimental group
swaddled
swaddled
the 1st experimental group were swaddled
2nd experimental group
inhale the mother's breast milk odour
mother's breast milk odor
the 2nd experimental group were made to inhale mother's breast milk odor
3rd experimental group
both swaddled and made to inhale the mother's breast milk odour
both swaddled and made to inhale mother's breast milk odor
the 3rd experimental group were both swaddled and made to inhale mother's breast milk odor
the control group
no procedure
No procedure
No procedure was applied to the infants in the control group.
Interventions
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swaddled
the 1st experimental group were swaddled
mother's breast milk odor
the 2nd experimental group were made to inhale mother's breast milk odor
both swaddled and made to inhale mother's breast milk odor
the 3rd experimental group were both swaddled and made to inhale mother's breast milk odor
No procedure
No procedure was applied to the infants in the control group.
Eligibility Criteria
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Exclusion Criteria
* Having been given analgesics
* Inability to open the vascular access in one go
1 Day
27 Days
ALL
Yes
Sponsors
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Zonguldak Bulent Ecevit University
OTHER
Responsible Party
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Ayla Gündoğdu Karakaya
Doctor of Pediatric Nursing
Principal Investigators
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ayla gündoğdu karakaya
Role: STUDY_DIRECTOR
zonguldak beun
Locations
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zonguldak BEU
Zonguldak, , Turkey (Türkiye)
Countries
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References
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Rad ZA, Aziznejadroshan P, Amiri AS, Ahangar HG, Valizadehchari Z. The effect of inhaling mother's breast milk odor on the behavioral responses to pain caused by hepatitis B vaccine in preterm infants: a randomized clinical trial. BMC Pediatr. 2021 Feb 1;21(1):61. doi: 10.1186/s12887-021-02519-0.
Lan HY, Yang L, Lin CH, Hsieh KH, Chang YC, Yin T. Breastmilk as a Multisensory Intervention for Relieving Pain during Newborn Screening Procedures: A Randomized Control Trial. Int J Environ Res Public Health. 2021 Dec 10;18(24):13023. doi: 10.3390/ijerph182413023.
Yilmaz D, Inal S. Effects of three different methods used during heel lance procedures on pain level in term neonates. Jpn J Nurs Sci. 2020 Oct;17(4):e12338. doi: 10.1111/jjns.12338. Epub 2020 Apr 2.
Related Links
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national thesis center
Other Identifiers
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3272493AGK
Identifier Type: -
Identifier Source: org_study_id
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