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Clinical Trials/NCT06120062
NCT06120062
Completed
Not Applicable

The Effect of Swaddling and Inhaling Breast Milk Odour on the Pain and Comfort During the Placement of Peripheral Intravenous Catheter in Term Infants

Zonguldak Bulent Ecevit University1 site in 1 country120 target enrollmentOctober 1, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Infant, Newborn
Sponsor
Zonguldak Bulent Ecevit University
Enrollment
120
Locations
1
Primary Endpoint
the effect of swaddling the pain and comfort during the placement of peripheral intravenous catheter
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

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 equally assigned 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 experimental group were both swaddled and made to inhale the mother's breast milk odour 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 (NIPS)" and "Neonatal Comfort Behaviour Scale (NCBS) were used to collect data.

Detailed Description

The effect of Swaddling and Inhaling Breast Milk Odour on the Pain and Comfort During the Placement of Peripheral Intravenous Catheter in Term Infants. 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.

Registry
clinicaltrials.gov
Start Date
October 1, 2020
End Date
January 13, 2023
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Zonguldak Bulent Ecevit University
Responsible Party
Principal Investigator
Principal Investigator

Ayla Gündoğdu Karakaya

Doctor of Pediatric Nursing

Zonguldak Bulent Ecevit University

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

the effect of swaddling the pain and comfort during the placement of peripheral intravenous catheter

Time Frame: 20 minutes

Infants in the 1st experimental group (Swaddling) were swaddled when they were laid under a radiant heater for the insertion of peripheral intravenous catheter. The Neonatal Infant Pain Scale (NIPS) and the Newborn Comfort Behavior Scale were evaluated by the researcher before and during the procedure, and 5 minutes after they were taken into the incubator.

Secondary Outcomes

  • the effect of inhaling mother's breast milk odour on the pain and comfort during the placement of peripheral intravenous catheter(20 minutes)

Study Sites (1)

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