IRCT201505142639N16.

Trial name or title	Efficacy of kangaroo mother care, breastfeeding and swaddling on BCG vaccine pain score in neonates
Methods	RCT
Participants	Inclusion criteria: Inclusion criteria: term neonates (gestation age of 37–42 weeks); birth weight of 2500 to 4000 g; product of normal vaginal delivery; without systemic illness and with healthy medical condition Exclusion criteria: birth asphyxia; severe congenital malformation; receiving sedative hypnotic drugs within the past 24 hours Exclusion criteria: Age minimum: 0 Age maximum: 0 Gender: both male and female
Interventions	Intervention 1: breast feeding two minutes before vaccination until one minute after BCG vaccination . Intervention 2: kangaroo mother care of neonate with close contact of thorax and abdomen skin of mother ten minutes before vaccination until one minute after BCG vaccination. Intervention 3: swaddling of neonate ten minutes before vaccination until one minute after BCG vaccination .
Outcomes	Obtaining of pain score of less than four during BCG vaccine injection. Timepoint: during BCG vaccine injection. Method of measurement: Neonatal/Infant Pain Scale Pain score of BCG vaccine injection. Timepoint: before, during, one minute and two minutes after BCG vaccine injection. Method of measurement: Neonatal/Infant Pain Scale Duration of neonate crying during BCG vaccine injection. Timepoint: every 10 seconds after vaccine injection until stopping of crying. Method of measurement: By chronometer
Starting date	24 April 2015
Contact information	Name: Dr. Razieh Fallah Address: Pediatric Ward, Shahid Sadoughi Hospital, Ebn ‐ Sina BLVD, Shahid Ghandi BlVD, Yazd, I.R.Iran Yazd Iran, Islamic Republic Of Telephone: 00983538224000 Email: dr.raziehfallah@yahoo.com Affiliation: Shahid Sadoughi University of Medical Sciences, Yazd, Iran
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