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

Sponsor

Zonguldak Bulent Ecevit University (Other)

Overall Status

Completed

CT.gov ID

NCT06120062

Collaborator

(none)

120

Enrollment

Location

27.4

Actual Duration (Months)

4.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Infant, Newborn Pain Perception	Other: swaddled Other: mother's breast milk odor Other: both swaddled and made to inhale mother's breast milk odor Other: No procedure

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.

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.

Study Design

Study Type:

Observational

Actual Enrollment :

120 participants

Observational Model:

Case-Control

Time Perspective:

Cross-Sectional

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

Actual Study Start Date :

Oct 1, 2020

Actual Primary Completion Date :

Oct 1, 2021

Actual Study Completion Date :

Jan 13, 2023

Arms and Interventions

Arm	Intervention/Treatment
1st experimental group swaddled	Other: swaddled the 1st experimental group were swaddled
2nd experimental group inhale the mother's breast milk odour	Other: 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	Other: 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	Other: No procedure No procedure was applied to the infants in the control group.

Outcome Measures

Primary Outcome Measures

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

the effect of inhaling mother's breast milk odour on the pain and comfort during the placement of peripheral intravenous catheter [20 minutes]
Infants 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 Outcome Measures

the effect of both swaddled and made to inhale mother's breast milk odor. [20 minutes]
Infants 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Day to 27 Days

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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