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NCT Number: NCT06120062

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

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.

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Key information

Conditions

Infant, Newborn Neurologic Manifestations Pain Pain Perception Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

1 day–27 day

Sex eligibility

All sexes

Study type

Observational

Primary location

zonguldak BEU

Zonguldak, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

swaddled

Other

the 1st experimental group were swaddled

mother's breast milk odor

Other

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

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

No procedure

Other

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

Primary outcomes

  1. the effect of swaddling the pain and comfort during the placement of peripheral intravenous catheter

    Time frame: 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 outcomes

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

    Time frame: 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.

Other outcomes

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

    Time frame: 20 minutes

    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.

Sponsors and collaborators

Lead sponsor

Zonguldak Bulent Ecevit University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2023
First posted
Nov 7, 2023
Registry last updated
Nov 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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