None listed
Conditions
Brief summary
This study addresses the question of whether there are differences in measures of infant stress during a routine heel prick blood sampling procedure between two conditions: a non-parental adult talking empathically during the procedure compared with silence during the procedure. Participating infants will be allocated to the two conditions, in random order. Each preterm infant will be 32 to 35 weeks gestational age at birth and will be having the heel prick blood tests as part of their usual treatment. Behavioural measures of infant stress will be captured on video. Physiological measures of stress will be assessed through continuous monitoring of infant heart rate, breathing and blood oxygen levels during the study period as well as six cotton wool swab saliva samples per infant to measure the stress hormone cortisol.
Interventions
All infants in this randomized controlled study will be exposed to the two study conditions – vocal soothing by a non parental adult during a routine heel prick procedure and no vocal soothing during a routine heel prick procedure. The vocal soothing will be offered by the primary investigator for this study. Vocal soothing will comprise matching vocal tone to the perceived infant emotional and physical experience, for example higher pitch, loud and with shorter sounds during the infant’s high
All infants in this randomized controlled study will be exposed to the two study conditions – vocal soothing by a non parental adult during a routine heel prick procedure and no vocal soothing during a routine heel prick procedure. The vocal soothing will be offered by the primary investigator for this study. Vocal soothing will comprise matching vocal tone to the perceived infant emotional and physical experience, for example higher pitch, loud and with shorter sounds during the infant’s high arousal and a lower pitch, quieter, longer sounds during low arousal. The purpose of the intervention will be to communicate to the infant that an adult is there and is sympathetic towards them. The vocal soothing intervention will be offered for 1 hour over the time of the heel prick procedure and subsequent care activities. There will be at least 12 hours between conditions. The exact timing between conditions will vary as the second study will take place at the time of the infant's next scheduled heelprick blood test, which will be dependant on clinical need.
Sponsors
Department of Paediatrics and Child health
Study design
Allocation
Randomised controlled trial
Primary purpose
Prevention
Eligibility
Sex/Gender
All
Age
24 Hours to 2 Weeks
Healthy volunteers
No
Inclusion criteria
Non-surgical preterm infants born at 32-35 weeks gestational age, who are in their first two weeks of life, having the heel prick blood tests as part of their usual care and are thought to be healthy enough to participate by their nurse.
Exclusion criteria
Infants who are sedated, on respiratory support or have had a surgical procedure (surgical infants)
Outcome results
None listed