Clinical trial NCT05656677: Parental Involvement in Pain Reducing Measures
Official title: Pain Responses in Preterm Infants and Parental Stress Over Repeated Painful Procedures: a Randomized Pilot Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Procedural Pain
Preterm Infants
Parents
Keywords: pain
stress
preterm infants
parents
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
First posted: 2022-12-19
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A three-arm pilot study using mixed methods of data collection (questionnaires, SCA, interviews) was designed to test the feasibility of the intervention encompassing parents' active and passive involvement in procedural pain management of extremely and preterm infants hospitalised at a neonatal intensive care unit (NICU).
Primary purpose: TREATMENT

Brief 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.

Detailed description: Objectives

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.

Eligibility criteria: Inclusion Criteria:

* Premature infants born at the NICU concerned
* 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 an umbilical artery pH measurement \<7.00 or asphyxia
* 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)

Primary outcomes:
measure: The main objective of this pilot study was to determine the feasibility of a larger, appropriately powered study
timeFrame: 1 year
measure: Percentage of questionnaire completion
timeFrame: 1 year
measure: The pain and stress measurement over three time points were reviewed for feasibility
timeFrame: 1 year
measure: The active parental involvement over three time points were reviewed for feasibility
timeFrame: 1 year
Secondary outcomes:
measure: The secondary interest of the study was to test for significant differences in parental stress between the two intervention and control group at three measurement points as well as infant pain.
timeFrame: 1 year
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: Inselspital
Study officials:
affiliation: Fac. Health, Medicine and Life Sciences, Health Services Research CAPHRI - University of Maastricht
name: Sandra Zwakhalen, Prof. Dr.
role: STUDY_CHAIR
References: