Parental Involvement in Pain Reducing Measures

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

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.

Study Overview

• Status: Completed
• Conditions: Preterm Infants; Parents; Procedural Pain
• Intervention / Treatment: Behavioral: Passive parental involvement; Radiation: Active parental involvement

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 Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Bern, Switzerland, 3010
    • Inselspital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Two nurses executing facilitated tucking (FT); Usual care
Active Comparator: One parent watching passively; One parent watching passively the 2 nurses executing FT	Behavioral: Passive parental involvement; One parent watching a procedural painful intervention, two nurses executing facilitated tucking
Active Comparator: One parent actively involved; One parent actively executing FT	Radiation: Active parental involvement; One parent watching a procedural painful intervention and at the same time executing facilitated tucking

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The main objective of this pilot study was to determine the feasibility of a larger, appropriately powered study	Feasibility assessment included recruitment rate (dependent on resources and in-/exclusion criteria)	1 year
Percentage of questionnaire completion	Check percentage of questionnaires completed and withdrawals; Interview parents about the feasibility of participating three times	1 year
The pain and stress measurement over three time points were reviewed for feasibility	-The research team was also interviewed about acceptance, applicability and feasibility of the validated BPSN, the SCA over three time points	1 year
The active parental involvement over three time points were reviewed for feasibility	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	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	1 year

Collaborators and Investigators

• Sponsor: University Hospital Inselspital, Berne
• Investigators: Study Chair: Sandra Zwakhalen, Prof. Dr., Fac. Health, Medicine and Life Sciences, Health Services Research CAPHRI - University of Maastricht

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2019
• Primary Completion (Actual): November 1, 2020
• Study Completion (Actual): November 1, 2022

Study Registration Dates

• First Submitted: November 30, 2022
• First Submitted That Met QC Criteria: December 12, 2022
• First Posted (Actual): December 19, 2022

Study Record Updates

• Last Update Posted (Actual): December 19, 2022
• Last Update Submitted That Met QC Criteria: December 12, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: pain; stress; preterm infants; parents
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Premature Birth; Pain, Procedural
• Other Study ID Numbers: 079/13

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Data collection of pain assessment
• IPD Sharing Time Frame: 1year
• IPD Sharing Access Criteria: Personal request
• IPD Sharing Supporting Information Type: Study Protocol

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No