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Parental Involvement in Pain Reducing Measures

NCT05656677 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2022-12-19

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Insel Gruppe AG, University Hospital Bern

    lead OTHER

Principal Investigators

  • Sandra Zwakhalen, Prof. Dr. · Fac. Health, Medicine and Life Sciences, Health Services Research CAPHRI - University of Maastricht

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-01
Primary Completion
2020-11-01
Completion
2022-11-01

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05656677 on ClinicalTrials.gov