Skip to content

Effect of Swaddling and Inhaling Breast Milk Odour on the Pain and Comfort

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06120062
Enrollment
120
Registered
2023-11-07
Start date
2020-10-01
Completion date
2023-01-13
Last updated
2023-11-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infant, Newborn, Pain Perception

Keywords

newborn, pain, comfort, nurse, Non-pharmacological Method

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.

Interventions

OTHERswaddled

the 1st experimental group were swaddled

OTHERmother's breast milk odor

the 2nd experimental group were made to inhale mother's breast milk odor

OTHERboth 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

OTHERNo procedure

No procedure was applied to the infants in the control group.

Sponsors

Zonguldak Bulent Ecevit University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
1 Days to 27 Days
Healthy volunteers
Yes

Inclusion 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

Design outcomes

Primary

MeasureTime frameDescription
the effect of swaddling the pain and comfort during the placement of peripheral intravenous catheter20 minutesInfants 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

MeasureTime frameDescription
the effect of inhaling mother's breast milk odour on the pain and comfort during the placement of peripheral intravenous catheter20 minutesInfants in the 2nd experimental group (Inhaling mother's breast milk odor) were made to inhale their mothers' breast milk odor 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.

Other

MeasureTime frameDescription
the effect of both swaddled and made to inhale mother's breast milk odor.20 minutesInfants in the 3rd experimental group (Swaddling and inhaling mother's breast milk odor) were both swaddled and made to inhale their mothers' breast milk odor 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.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026