NCT06859632

Brief Summary

The goal for this trial is to test the effect of an educational programme on communication and play for healthcare professionals working with children and adolescents. The main questions to answer are:

  1. 1.Does a 45-minute educational intervention on communication and play have the same effect on healthcare professionals' self-efficacy in patient-centredness compared with a three-hour intervention?
  2. 2.What is the effect of the intervention on participants' motivation to engage in the educational activity, cognitive load, knowledge, satisfaction, and the impact on their individual practice ?

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 25, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 5, 2025

Completed
Same day until next milestone

Study Start

First participant enrolled

March 5, 2025

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2025

Completed
Last Updated

July 10, 2025

Status Verified

March 1, 2025

Enrollment Period

8 months

First QC Date

February 25, 2025

Last Update Submit

July 7, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Self-efficacy

    Self-efficacy measured using a 10-item questionnaire on a 5-point likert scale (1 = very low degree, 5 = very high degree). Questions are adapted from the Danish version of the validated Self-Efficacy in Patient-Centeredness Questionnaire (SEPCQ-27).This questionnaire evaluates participants' confidence in their ability to build relationships and communicate with children and adolescents in hospital settings.

    From enrollment to 12-week follow-up

Secondary Outcomes (5)

  • Motivation

    Immediately after intervention

  • Self-evaluated knowledge about paediatric communication

    From enrollment to 12 week follow-up

  • Cognitive load

    Immediately after intervention

  • Satisfaction with intervention

    Immediately after intervention

  • Impact on individual practice and training need

    12 week follow-up

Study Arms (2)

45-minute educational intervention

ACTIVE COMPARATOR

Participants will receive a 45-minute educational intervention on communication and the use of play in paediatric clinical practice

Other: 45-minute educational intervention

3-hour educational intervention

EXPERIMENTAL

Participants will receive a 3-hour educational intervention on communication and the use of play in paediatric clinical practice

Other: 3-hour educational intervention

Interventions

A 3-hour educational intervention on communication and the use of play in paediatric clinical practice. Participants in both arms will have access to written learning material and an app that has been developed.

3-hour educational intervention

A 45-minute educational intervention on communication and the use of play in paediatric clinical practice. Participants in both arms will have access to written learning material and an app that has been developed.

45-minute educational intervention

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Healthcare professionals employed in the Department of Paediatrics and Adolescent Medicine at Rigshospitalet (nurses, doctors, physiotherapist, occupational therapists, dieticians, medical secretaries, and social workers)
  • Provide signed informed consent before randomisation

You may not qualify if:

  • Staff taking part in planning of the intervention
  • Lack of informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rigshospitalet

Copenhagen, 2100, Denmark

Location

Related Publications (8)

  • Krebs CL, Thestrup J, Hybschmann J, Graber K, Gjaerde LK, Topperzer MK, Nielsen ET, Larsen A, Ramchandani P, Frandsen TL, Sorensen JL. A BEME review of educational programmes on the use of play in paediatric practice: BEME Guide No. 82. Med Teach. 2024 Nov;46(11):1393-1403. doi: 10.1080/0142159X.2023.2287983. Epub 2023 Dec 14.

    PMID: 38098168BACKGROUND
  • Thestrup J, Sorensen JL, Esbjorn BH, Hybschmann J, Frandsen TL, DeCosta P, Gjaerde LK. Paediatric patient perceptions of healthcare professionals: contributions to a communication curriculum. Eur J Pediatr. 2024 Dec 12;184(1):75. doi: 10.1007/s00431-024-05911-x.

    PMID: 39663230BACKGROUND
  • Jeppesen E, Schmidt AA, Skjodt CK, Hybschmann J, Gjaerde LK, Thestrup J, Hansson H, Sorensen JL. Educational programmes for paediatric healthcare professionals in patient- and family-centred care. A scoping review. Eur J Pediatr. 2024 May;183(5):2015-2028. doi: 10.1007/s00431-024-05455-0. Epub 2024 Mar 2.

    PMID: 38430279BACKGROUND
  • Thestrup J, Sorensen JL, Hybschmann J, Topperzer MK, Graber K, O'Farrelly C, Gibson J, Ramchandani P, Frandsen TL, Gjaerde LK. Establishing consensus on principles and competencies for the use of play in clinical practice in hospitals: An international Delphi study. Eur J Pediatr. 2024 Apr;183(4):1595-1605. doi: 10.1007/s00431-023-05411-4. Epub 2024 Jan 6.

    PMID: 38183437BACKGROUND
  • Gjaerde LK, Hybschmann J, Dybdal D, Topperzer MK, Schroder MA, Gibson JL, Ramchandani P, Ginsberg EI, Ottesen B, Frandsen TL, Sorensen JL. Play interventions for paediatric patients in hospital: a scoping review. BMJ Open. 2021 Jul 26;11(7):e051957. doi: 10.1136/bmjopen-2021-051957.

    PMID: 34312210BACKGROUND
  • Davison G, Conn R, Kelly MA, Thompson A, Dornan T. Fifteen-minute consultation: Guide to communicating with children and young people. Arch Dis Child Educ Pract Ed. 2023 Apr;108(2):91-95. doi: 10.1136/archdischild-2021-323302. Epub 2021 Dec 2.

    PMID: 34857651BACKGROUND
  • Hoeg BL, Sevillano PB, Enesco I, Wakefield CE, Larsen HB, Bidstrup PE. Child-centered communication interventions in pediatric oncology: A scoping review and proposed new communication model. Pediatr Blood Cancer. 2023 Jul 4:e30533. doi: 10.1002/pbc.30533. Online ahead of print.

    PMID: 37401446BACKGROUND
  • Thestrup J, Sorensen JL, Bidstrup PE, Rosthoj S, Hybschmann J, Esbjorn BH, Dybdal D, Barslund K, Topperzer MK, Frandsen TL, Gjaerde LK. Effect on healthcare professionals' self-efficacy of a 45-min versus 3-hour educational intervention on communication and play in paediatric clinical practice in Denmark: a randomised controlled trial study protocol. BMJ Open. 2025 Sep 14;15(9):e101703. doi: 10.1136/bmjopen-2025-101703.

MeSH Terms

Conditions

Communication

Condition Hierarchy (Ancestors)

Behavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MscGH, PhD candidate

Study Record Dates

First Submitted

February 25, 2025

First Posted

March 5, 2025

Study Start

March 5, 2025

Primary Completion

October 30, 2025

Study Completion

October 30, 2025

Last Updated

July 10, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

De-identified individual participant data to replicate the analysis will be available from the corresponding author (ORCID: 0000-0002-0093-8555) on reasonable request until five years after completion of the study, according to Danish law.

Locations