NCT05656677

Parental Involvement in Pain Reducing Measures

Pain Responses in Preterm Infants and Parental Stress Over Repeated Painful Procedures: a Randomized Pilot Trial.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Insel Gruppe AG, University Hospital Bern · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Procedural Pain
• Preterm Infants
• Parents

Interventions

Type	Name	Description
BEHAVIORAL	Passive parental involvement	One parent watching a procedural painful intervention, two nurses executing facilitated tucking
RADIATION	Active parental involvement	One parent watching a procedural painful intervention and at the same time executing facilitated tucking

Timeline

• Start date: 2019-10-01
• Primary completion: 2020-11-01
• Completion: 2022-11-01
• First posted: 2022-12-19
• Last updated: 2022-12-19

Locations

1 site across 1 country: Switzerland