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

Completed

• Conditions: Pain Perception; Infant, Newborn
• Interventions: Other: swaddled; Other: No procedure; Other: mother's breast milk odor; Other: both swaddled and made to inhale mother's breast milk odor

• Registration Number: NCT06120062
• Lead Sponsor: Zonguldak Bulent Ecevit University

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.

Study Timeline

• Study Start: 2020-10-01
• Primary Completion: 2021-10-01
• Study Completion: 2023-01-13
• Study First Submitted: 2023-02-19
• Status Verified: 2023-10
• Study First Submitted QC: 2023-10-31
• Last Update Submitted: 2023-10-31
• Study First Posted: 2023-11-07
• Last Update Posted: 2023-11-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
1st experimental group	swaddled	swaddled
the control group	No procedure	no procedure
2nd experimental group	mother's breast milk odor	inhale the mother's breast milk odour
3rd experimental group	both swaddled and made to inhale mother's breast milk odor	both swaddled and made to inhale the mother's breast milk odour

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

zonguldak BEU; 🇹🇷 Zonguldak, Turkey