Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
20 participants
INTERVENTIONAL
2019-10-01
2022-11-01
Brief Summary
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Detailed Description
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In this pilot study, the aims were to determine the feasibility of whether pain behaviour in extremely and very preterm infants and perceived parental stress change when parents are involved in pain reducing measures, either actively, performing facilitated tucking or passively, observing the intervention, in comparison to the involvement of nurses only. In addition, the infant's pain reactivity and parental stress over three time points of measurement was of interest.
Methods
Extremely and very preterm infants in need of subcutaneous erythropoietin were randomly assigned to the two intervention groups. The intervention encompassed that one parent of each infant was involved during the painful procedure: Either parents executed facilitated tucking themselves or stood by, observing the procedure. Usual care involved that nurse executed facilitated tucking. All infants received 0.5ml of 30% oral glucose solution via cotton swab before the painful procedure. Infant pain was observed with the Bernese Pain Scale for Neonates (BPSN) and measured with the skin conductance algesimeter (SCA) before, during, and after the procedure. Parents' stress levels were measured before and after the painful procedure on the infant, using the Current Strain Short Questionnaire (CSSQ).
Feasibility of a subsequent trial was determined by assessing recruitment, measurement and active parental involvement. Quantitative data collection methods (i.e., questionnaires, algesimeter) were employed to determine the number of participants for a larger trial and measurement adequacy. Qualitative data (interviews) was employed to determine parents' perspectives of their involvement.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
The CNS or the neonatologist provided information about the study to the parents, without stating its specific aim, instead referring in principle to the increased involvement of parents in pain management.
Study Groups
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Two nurses executing facilitated tucking (FT)
Usual care
No interventions assigned to this group
One parent watching passively
One parent watching passively the 2 nurses executing FT
Passive parental involvement
One parent watching a procedural painful intervention, two nurses executing facilitated tucking
One parent actively involved
One parent actively executing FT
Active parental involvement
One parent watching a procedural painful intervention and at the same time executing facilitated tucking
Interventions
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Passive parental involvement
One parent watching a procedural painful intervention, two nurses executing facilitated tucking
Active parental involvement
One parent watching a procedural painful intervention and at the same time executing facilitated tucking
Eligibility Criteria
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Inclusion Criteria
* Born between 24 0/7- 32 0/7 weeks of gestation, birthweight (bw) \<1250g
* Infant in need of s.c. erythropoietin
* Parents fluently speaking and writing in German
* Written informed consent by parents
Exclusion Criteria
* Premature infant with life threatening malformations of the central nervous system
* Premature infant with intracranial haemorrhage (even if not present at the start of the study)
* Premature infant with any surgical intervention
* Parents with substance abuse (i.e., methadone, heroin, etc.), as mentioned in the electronic patient documentation (EPD)
ALL
No
Sponsors
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Insel Gruppe AG, University Hospital Bern
OTHER
Responsible Party
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Principal Investigators
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Sandra Zwakhalen, Prof. Dr.
Role: STUDY_CHAIR
Fac. Health, Medicine and Life Sciences, Health Services Research CAPHRI - University of Maastricht
Locations
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Inselspital
Bern, , Switzerland
Countries
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Other Identifiers
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079/13
Identifier Type: -
Identifier Source: org_study_id