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

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.

Study Overview

• Status: Completed
• Conditions: Infant, Newborn; Pain Perception
• Intervention / Treatment: 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.

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.

• Study Type: Observational
• Enrollment (Actual): 120

Contacts and Locations

Study Locations

• Turkey
  • Zonguldak, Turkey
    • zonguldak BEU

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

• 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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the effect of swaddling the pain and comfort during the placement of peripheral intravenous catheter	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.	20 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the effect of inhaling mother's breast milk odour on the pain and comfort during the placement of peripheral intravenous catheter	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.	20 minutes

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
the effect of both swaddled and made to inhale mother's breast milk odor.	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.	20 minutes

Collaborators and Investigators

• Sponsor: Zonguldak Bulent Ecevit University
• Investigators: Study Director: ayla gündoğdu karakaya, zonguldak beun

Publications and helpful links

General Publications

• 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.

Helpful Links

• national thesis center

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2020
• Primary Completion (Actual): October 1, 2021
• Study Completion (Actual): January 13, 2023

Study Registration Dates

• First Submitted: February 19, 2023
• First Submitted That Met QC Criteria: October 31, 2023
• First Posted (Actual): November 7, 2023

Study Record Updates

• Last Update Posted (Actual): November 7, 2023
• Last Update Submitted That Met QC Criteria: October 31, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: pain; comfort; nurse; newborn; Non-pharmacological Method
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Respiratory Aspiration
• Other Study ID Numbers: 3272493AGK

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No