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Study aim
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Comparison the effect of breast milk and rosa damascena essential oil odor on pain and duration of crying due to blood sampling in neonates
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Design
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Cross over clinical trial, phase 2-3 with 40 neonates
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Settings and conduct
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In this research, the study population are neonates with a fetal age more than 32 weeks admitted to the NICU of Ali Ibn Abitaleb Hospital. Neonates will be select by convenience sampling method based on inclusion criteria. In the first stage, the neonate will expose to a cotton ball soaked in 2 cc of breast milk at a distance of 3 cm from the nose 3 minutes before the blood sampling until the end. In the next step, a cotton ball soaked in 2 drops of 10% rose essential oil will used similar to the breast milk method. For second sample, rose essential oil will used first time and then breast milk in the second time and so on until the end.
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Participants/Inclusion and exclusion criteria
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Fetal age between 32-42 weeks, neonatal age between 1-10 days, 5-minute Apgar scores higher than 7, parental inform consent for participate, stability of clinical status, newborn awake state and one hour after breastfeeding are inclusion criteria. Hypoglycemia, intubation, congenital or chromosomal abnormalities, painful procedure such as suctioning or blood sampling before the intervention, receiving sedative 24 hours before the intervention, crying and feeding with formula are exclusion criteria.
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Intervention groups
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Group A: the neonate will expose to a cotton ball soaked in 2 cc of breast milk at a distance of 3 cm from the nose 3 minutes before the blood sampling until the end. In the next step, the need for blood sampling in this neonate, a cotton ball soaked in 2 drops of 10% rose essential oil will used similar to the breast milk method. Group B: rose essential oil will used first time and then breast milk in the second time.
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Main outcome variables
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Score of pain؛ Duration of crying