Parental Involvement in Pain Reducing Measures

Parents Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05656677
• Other study ID #: 079/13
• Status: Completed
• Phase: N/A
• Start date: October 1, 2019
• Est. completion date: November 1, 2022

Study information

• Verified date: December 2022
• Source: University Hospital Inselspital, Berne
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: November 1, 2022
• Est. primary completion date: November 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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)

Related Conditions & MeSH terms

• Pain, Procedural
• Parents
• Premature Birth
• Preterm Infants
• Procedural Pain

Intervention

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

Locations

Country	Name	City	State
Switzerland	Inselspital	Bern

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Inselspital, Berne

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Percentage of questionnaire completion	Check percentage of questionnaires completed and withdrawals; Interview parents about the feasibility of participating three times	1 year
Primary	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
Primary	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	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: a=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