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

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Effect of Swaddling and Inhaling Breast Milk Odour on the Pain and Comfort During the Placement of Peripheral Intravenous Catheter in Term Infants

Conditions
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Infant, Newborn, Pain Perception

Intervention / Treatment
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* Other: swaddled
* Other: mother's breast milk odor
* Other: both swaddled and made to inhale mother's breast milk odor
* Other: No procedure


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 27 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1st experimental group<br>swaddled | Other: swaddled<br>* the 1st experimental group were swaddled<br>|
| 2nd experimental group<br>inhale the mother's breast milk odour | Other: mother's breast milk odor<br>* the 2nd experimental group were made to inhale mother's breast milk odor<br>|
| 3rd experimental group<br>both swaddled and made to inhale the mother's breast milk odour | Other: both swaddled and made to inhale mother's breast milk odor<br>* the 3rd experimental group were both swaddled and made to inhale mother's breast milk odor<br>|
| the control group<br>no procedure | Other: No procedure<br>* No procedure was applied to the infants in the control group.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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newborn, pain, comfort, nurse, Non-pharmacological Method