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

NCT06120062 | Completed

• 1 other identifier: 3272493AGK
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Infant, Newborn; Pain Perception

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

  20 minutes

Other Outcomes (1)

• the effect of both swaddled and made to inhale mother's breast milk odor.

  20 minutes

Study Arms (4)

1st experimental group

swaddled

Other: swaddled

2nd experimental group

inhale the mother's breast milk odour

Other: 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 control group

no procedure

Other: No procedure

Interventions

swaddled OTHER

the 1st experimental group were swaddled

1st experimental group

mother's breast milk odor OTHER

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

2nd experimental group

both swaddled and made to inhale mother's breast milk odor OTHER

the 3rd experimental group were both swaddled and made to inhale mother's breast milk odor

3rd experimental group

No procedure OTHER

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

the control group

Eligibility Criteria

• Age: 1 Day - 27 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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

You may not qualify if:

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

Sponsors & Collaborators

• Zonguldak Bulent Ecevit University: lead

Study Sites (1)

zonguldak BEU

Zonguldak, Turkey (Türkiye)

Location

Related Publications (3)

• 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.

  PMID: 33522927 RESULT

• 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.

  PMID: 34948633 RESULT

• 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.

  PMID: 32239753 RESULT

Related Links

• national thesis center

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• ayla gündoğdu karakaya

  zonguldak beun

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor of Pediatric Nursing

Study Record Dates

• First Submitted: February 19, 2023
• First Posted: November 7, 2023
• Study Start: October 1, 2020
• Primary Completion: October 1, 2021
• Study Completion: January 13, 2023
• Last Updated: November 7, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)