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

NCT06120062 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 120

Last updated 2023-11-07

No results posted yet for this study

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

Interventions

OTHER

swaddled

the 1st experimental group were swaddled

OTHER

mother's breast milk odor

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

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

OTHER

No procedure

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

Sponsors & Collaborators

  • Zonguldak Bulent Ecevit University

    lead OTHER

Principal Investigators

  • ayla gündoğdu karakaya · zonguldak beun

Eligibility

Min Age
1 Day
Max Age
27 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-10-01
Primary Completion
2021-10-01
Completion
2023-01-13

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06120062 on ClinicalTrials.gov