45 Minutes Vs. Three Hours Educational Intervention on Communication and Play for Paediatric Healthcare Professionals

July 7, 2025 updated by: Jakob Thestrup Hansen, Rigshospitalet, Denmark

Effect on Healthcare Professionals' Self-efficacy of a 45-minute vs Three-hour Educational Intervention on Communication and Play in Paediatric Clinical Practice: A Randomised Controlled Trial Study Protocol

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. 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. 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 ?

Participants will be randomly assigned to either a 45-minute or a three-hour educational intervention. They will complete a questionnaire at three time points: before the intervention, immediately after, and at a 12-week follow-up.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
150

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Denmark
      • Copenhagen, Denmark, 2100
        • Rigshospitalet

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: 45-minute educational intervention
Participants will receive a 45-minute educational intervention on communication and the use of play in paediatric clinical practice
Other: 45-minute 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.
Experimental: 3-hour educational intervention
Participants will receive a 3-hour educational intervention on communication and the use of play in paediatric clinical practice
Other: 3-hour educational intervention

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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Self-efficacy
Time Frame: From enrollment to 12-week follow-up
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Motivation
Time Frame: Immediately after intervention
Motivation measured by using the validated Intrinsic Motivation Inventory (IMI). The IMI is a self-report questionnaire that measures a person's subjective experience related to a specific activity on a Likert scale ranging from 1 (Not at all true) to 7 (Very true). The standard IMI includes 22 items. For this study, the 7-item Interest/Enjoyment subscale is used, which is considered to directly measure intrinsic motivation related to a recently completed activity.
Immediately after intervention
Self-evaluated knowledge about paediatric communication
Time Frame: From enrollment to 12 week follow-up
The participants self-perceived knowledge about paediatric communication will be assessed using a single item. The question is "What is your knowledge about age-appropriate communication with children and adolescents?" (5 point Likert scale from "no knowledge" to "very high knowledge").
From enrollment to 12 week follow-up
Cognitive load
Time Frame: Immediately after intervention
Measured using the Mental effort rating scale by Paas (1992). This validated, single item measure asks participants to rate their perceived mental effort ranging from "very, very low mental effort" to "very, very high mental effort" on a 9-point Likert scale.
Immediately after intervention
Satisfaction with intervention
Time Frame: Immediately after intervention
Participant satisfaction will be measured using a pre-designed questionnaire to assess participants' perceptions and satisfaction with the interventions. It will include five items covering relevance to clinical practice, overall quality, and whether they would recommend it to other healthcare professionals. One open-ended questions will invite participants to share general feedback and any additional comments about their experience.
Immediately after intervention
Impact on individual practice and training need
Time Frame: 12 week follow-up
Impact on individual practice and training needs will be evaluated through five items that examine whether participants changed their own practice, engaged with further reading, or identified a need for more training. Possible scores range from 1 (not at all) to 5 (to a very high degree).
12 week follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Rigshospitalet, Denmark

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 5, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 30, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 30, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 25, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 3, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 5, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 10, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 7, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • P-2021-426

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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