Parental Involvement in Pain Reducing Measures

Insel Gruppe AG, University Hospital Bern

Status: Completed

Conditions: Preterm Infants; Parents; Procedural Pain

Treatments: Behavioral: Passive parental involvement; Radiation: Active parental involvement

Study type: Interventional

Funder types: Other

Identifiers

NCT05656677

079/13

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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20 participants in 3 patient groups

Two nurses executing facilitated tucking (FT)

No Intervention group

Description:

Usual care

One parent watching passively

Active Comparator group

Description:

One parent watching passively the 2 nurses executing FT

Treatment:

Behavioral: Passive parental involvement

One parent actively involved

Active Comparator group

Description:

One parent actively executing FT

Treatment:

Radiation: Active parental involvement