Parental Involvement in Pain Reducing Measures

Not Applicable

Completed

• Conditions: Procedural Pain; Parents; Preterm Infants
• Interventions: Radiation: Active parental involvement; Behavioral: Passive parental involvement

• Registration Number: NCT05656677
• Lead Sponsor: Insel Gruppe AG, University Hospital Bern

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.

Study Timeline

• Study Start: 2019-10-01
• Primary Completion: 2020-11-01
• Study Completion: 2022-11-01
• Study First Submitted: 2022-11-30
• Status Verified: 2022-12
• Study First Submitted QC: 2022-12-12
• Last Update Submitted: 2022-12-12
• Study First Posted: 2022-12-19
• Last Update Posted: 2022-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
One parent actively involved	Active parental involvement	One parent actively executing FT
One parent watching passively	Passive parental involvement	One parent watching passively the 2 nurses executing FT

Primary Outcome Measures

Name	Time	Method
Percentage of questionnaire completion	1 year	* Check percentage of questionnaires completed and withdrawals; * Interview parents about the feasibility of participating three times
The active parental involvement over three time points were reviewed for feasibility	1 year	In semi-structured interviews, parents were asked about performing facilitated tucking or standing by as observers, acceptance, applicability and feasibility of the CSSQ and measurement over three time-points; -The research team was also interviewed about active parental involvement
The main objective of this pilot study was to determine the feasibility of a larger, appropriately powered study	1 year	Feasibility assessment included recruitment rate (dependent on resources and in-/exclusion criteria)
The pain and stress measurement over three time points were reviewed for feasibility	1 year	-The research team was also interviewed about acceptance, applicability and feasibility of the validated BPSN, the SCA over three time points

Secondary Outcome Measures

Name	Time	Method
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.	1 year	To determine infant pain, two research team nurses observed the infant by using the Bernese Pain Scale for Neonates (BPSN) in real time before (2-3 minutes), during and (2-3 and 10 minutes) after the s.c. injection. The two nurses independently assessed the physiological and behavioural pain items \[(18)\]. The BPSN is a multidimensional tool in German and has shown satisfactory psychometric properties among preterm and term infants (validity: r = 0.75; reliability: α=0.8) \[(18)\].; Skin Conductance Algesimeter (SCA) was installed before the s.c. injection until the last BPSN measurement. An electrocardiogram electrode (ECG) was placed on the sole of the foot to the left and right of the ankle of the preterm infant. An initial baseline was obtained. Subsequently, SCA pain measurement was continuous.

Trial Locations

Locations (1)

Inselspital; 🇨🇭 Bern, Switzerland