Clinical trial NCT06120062: Effect of Swaddling and Inhaling Breast Milk Odour on the Pain and Comfort
Official title: The Effect of Swaddling and Inhaling Breast Milk Odour on the Pain and Comfort During the Placement of Peripheral Intravenous Catheter in Term Infants
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infant, Newborn
Pain Perception
Keywords: newborn
pain
comfort
nurse
Non-pharmacological Method
Lead sponsor: Zonguldak Bulent Ecevit University
Sponsor class: OTHER
First posted: 2023-11-07
Enrollment: 120
Sex: ALL
Minimum age (years): 1
Maximum age (years): 27
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 120 and term infants were equallyassigned to three experimental groups and a control group, each of which consisted of 30 infants

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.

Eligibility criteria: Sample selection criteria of the study

* Being a term infant (born at 37-41 weeks of gestation)
* Being currently hospitalized in the neonatal intensive care unit
* Not having a previous insertion of peripheral intravenous catheter
* Having the insertion of peripheral intravenous catheter for the first time
* Having no invasive procedures before (insertion of peripheral intravenous catheter, urethral Foley catheterisation, nasogastric tube insertion, etc.)
* Having no analgesic before the procedure

Exclusion criteria of the study

* Refusing to participate in the research
* Having been given analgesics
* Inability to open the vascular access in one go

Primary outcomes:
measure: the effect of swaddling the pain and comfort during the placement of peripheral intravenous catheter
timeFrame: 20 minutes
Secondary outcomes:
measure: the effect of inhaling mother's breast milk odour on the pain and comfort during the placement of peripheral intravenous catheter
timeFrame: 20 minutes
Other outcomes:
measure: the effect of both swaddled and made to inhale mother's breast milk odor.
timeFrame: 20 minutes
Locations:
city: Zonguldak
country: Turkey
facility: zonguldak BEU
Study officials:
affiliation: zonguldak beun
name: ayla gündoğdu karakaya
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.