Parental Involvement in Pain Reducing Measures

NCT05656677 | Completed DMC

• 1 other identifier: 079/13
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Procedural Pain; Preterm Infants; Parents

Keywords

pain; stress; preterm infants; parents

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (1)

• 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

Study Arms (3)

Two nurses executing facilitated tucking (FT)

NO INTERVENTION

Usual care

One parent watching passively

ACTIVE COMPARATOR

One parent watching passively the 2 nurses executing FT

Behavioral: Passive parental involvement

One parent actively involved

ACTIVE COMPARATOR

One parent actively executing FT

Radiation: Active parental involvement

Interventions

Passive parental involvement BEHAVIORAL

One parent watching a procedural painful intervention, two nurses executing facilitated tucking

One parent watching passively

Active parental involvement RADIATION

One parent watching a procedural painful intervention and at the same time executing facilitated tucking

One parent actively involved

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

Study Sites (1)

Inselspital

Bern, 3010, Switzerland

Location

MeSH Terms

Conditions

Pain, Procedural; Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Sandra Zwakhalen, Prof. Dr.

  Fac. Health, Medicine and Life Sciences, Health Services Research CAPHRI - University of Maastricht

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: The six NICU nurses involved were blinded to the purpose of the study, whereas the clinical nurse specialist (CNS) was not. Always three members of this research team conducted the pain assessment during the facilitated tucking or the observing by the parents. The other three members of the research team focused on the nurses' group. The CNS or the neonatologist provided information about the study to the parents, without stating its specific aim, instead referring in principle to the increased involvement of parents in pain management.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A three-arm pilot study using mixed methods of data collection (questionnaires, SCA, interviews) was designed to test the feasibility of the intervention encompassing parents' active and passive involvement in procedural pain management of extremely and preterm infants hospitalised at a neonatal intensive care unit (NICU).

Study Record Dates

• First Submitted: November 30, 2022
• First Posted: December 19, 2022
• Study Start: October 1, 2019
• Primary Completion: November 1, 2020
• Study Completion: November 1, 2022
• Last Updated: December 19, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 1year
• Access Criteria: Personal request

Locations

CH (1)