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Completed
NCT05656677
Parental Involvement in Pain Reducing Measures
Conditions: Procedural Pain, Preterm Infants, Parents
Sex: All
Phase: NA
Enrollment: 20
Sponsor: University Hospital Inselspital, Berne
Location: Switzerland
Summary
This pilot study was conceptualised to determine the feasibility of involving parents via facilitated tucking or observing during painful procedures and to measure change in parental stress and infant pain.
An additional purpose of this pilot study was to determine the size of the cohort of preterm infants needed for a larger trial, the time, and resources required for recruitment and data collection.
Eligibility Criteria
Inclusion Criteria:Premature infants born at the NICU concernedBorn between 24 0/7- 32 0/7 weeks of gestation, birthweight (bw) <1250gInfant in need of s.c.
erythropoietinParents fluently speaking and writing in GermanWritten informed consent by parentsExclusion Criteria:Premature infant with an umbilical artery pH measurement <7.00 or asphyxiaPremature infant with life threatening malformations of the central nervous systemPremature infant with intracranial haemorrhage (even if not present at the start of the study)Premature infant with any surgical interventionParents with substance abuse (i.e., methadone, heroin, etc.), as mentioned in the electronic patient documentation (EPD)
Source: ClinicalTrials.gov (NCT05656677). StuddyBuddy aggregates publicly available trial information.
