BACKGROUND: Communication is an essential skill for all healthcare professionals working
with children and adolescents in hospitals. There is growing focus on child-centred
communication, which emphasize communicating directly with children and adolescents in
healthcare rather than focusing on the parents. However, educational programmes for this
remain limited while those that exist are heterogenous and often assessed without
comparison groups or validated tools.
OBJECTIVE: To investigate the effect on healthcare professionals' self-efficacy of a
45-minute vs three-hour educational intervention on communication and the use of play in
clinical paediatric practice
INTERVENTION: This trial evaluates the educational programme "Communication and Play with
Children and Adolescents in Healthcare", which focuses on age-appropriate communication
with paediatric patients, including the deliberate use of play. The trial compares two
educational interventions that differ in duration (45 minutes vs. three hours) and
learning methods. While both interventions include didactic learning, reflection, and
discussions, the three-hour session adds role-play activities, whereas the 45-minute
session delivers a condensed version without role-play.
DESIGN: Single-centre, randomized, controlled, two-arm, noninferiority trial. A
noninferiority design is used to assess whether there is a difference between the two
educational interventions or if the 45-minute educational intervention is comparable to
the three-hour educational intervention.
SETTING: The University Hospital of Copenhagen - Rigshospitalet, Denmark.
RECRUITMENT: All healthcare professionals working in the Department of Paediatrics and
Adolescent Medicine at Rigshospitalet will be eligible to participate. Potential
participants will be contacted by their leaders and be informed of the study. A written
consent will then be obtained.
SAMPLE SIZE: The sample size calculation assumes that the 45-minute intervention is as
effective as the three-hour intervention for the primary outcome (self-efficacy). A
non-inferiority margin of 0.25 points is set, meaning the mean self-efficacy score for
the 45-minute intervention can be up to 0.25 points lower than that of the three-hour
intervention without being considered inferior. Based on a one-sided two-sample t-test
with a margin of 0.25, an alpha of 0.025, a power of 80%, and a standard deviation of
0.45 derived from the pilot study, the required sample size is 52 participants per group.
Since the intervention is conducted in clusters of 25 participants, the sample size
calculation is adjusted for cluster randomization by multiplying by the design effect,
calculated as 1 + (cluster size - 1) × ICC. Assuming an ICC of 0.01 results in a design
effect of 1.24 and an adjusted sample size of 65 per group. Accounting for a 10% dropout
rate, the final required sample size is 72 per group. It is planned to include a total of
150 participants.
RANDOMIZATION: Eligible participants will be randomly assigned in a 1:1 ratio to either a
45-minute educational intervention or a three-hour educational intervention using
computer-generated block randomization through REDCap. The randomization process will
ensure an interprofessional distribution of participants in each intervention group. Both
the statistician and the researchers conducting the analysis will be blinded to
participant allocation.
ETHICS: This trial complies with the principles outlined in the Declaration of Helsinki
for biomedical research. Approval has been obtained from the Danish Data Protection
Agency (P-2021-426). The study was approved but deemed exempt from requiring ethical
approval by The Scientific Ethical Committees for the Capital Region of Denmark
(Journal-nr.: H-21028050). Participation is entirely voluntary, and both educational
interventions will take place during working hours at no cost to the participants.
Participants may withdraw from the study at any time without any repercussions. To ensure
confidentiality, all data will be securely stored in a protected database.