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

Abstract

Introduction

Communication is a professional competence that all paediatric healthcare professionals must learn and maintain to provide age and developmentally appropriate care. Child-centred communication encourages direct communication with children and adolescents, incorporating the use of play as a communicative strategy. Still, many paediatric healthcare professionals receive little or no formal training in communication and play. A critical barrier to communication training is the limited possibilities for healthcare professionals to take time from their clinical duties. Moreover, few randomised controlled trials have evaluated educational programmes on communication and play for paediatric healthcare professionals, and existing programmes vary significantly in design and duration. This study aims to compare the effects of a 45-min and a 3-hour educational intervention for healthcare professionals on age-appropriate communication and the use of play in clinical paediatric practice.

Methods and analysis

We will describe a single-centre, randomised, controlled, two-arm, non-inferiority trial. We will recruit 150 healthcare professionals with different professional backgrounds who will be randomised to one of two arms: a 45-min or 3-hour educational intervention on communication and play in paediatric clinical practice. The primary outcome will be their self-efficacy in patient-centredness at 12-week post-intervention, while secondary outcomes will be self-efficacy immediately after the intervention, motivation to engage in the educational activity, cognitive load, self-evaluated knowledge, satisfaction and the impact on individual practice and training needs. Data will be collected through questionnaires at baseline, immediately after the intervention, and 12 weeks post-intervention and will be analysed using linear mixed models with random effects to account for clustering and within-subject correlation.

Ethics and dissemination

The Danish Data Protection Agency approved the study (P-2020–1144), which will be conducted in accordance with the Declaration of Helsinki. Findings will be published in a peer-reviewed open-access scientific journal and presented at international conferences.

Trial registration number

NCT06859632 (ClinicalTrials.gov).

STRENGTHS AND LIMITATIONS OF THIS STUDY.

• This study will use a randomised controlled trial to evaluate educational interventions on communication and play for paediatric healthcare professionals, which has rarely been done.

• To ensure a broad range of perspectives, this study will include a diverse group of healthcare professionals from various units, including medical doctors, nurses, physiotherapists, medical secretaries and dietitians. The study will be conducted at one centre, which may limit generalisability.

• Self-reporting will allow participants to reflect on their learning experience and can be used to measure educational goals such as self-efficacy and intrinsic motivation but may affect reporting accuracy.

• The use of role-play in the educational intervention may present challenges. Some participants may have difficulty adopting the role of a paediatric patient and/or engaging in role-play without feeling self-conscious.

• This study will not assess patient outcomes, though a future study will.

Background

Paediatric patients often struggle to understand information in hospitals and do not feel involved in their own treatment and care.1,3 Numerous studies have shown that effective communication between healthcare professionals (HCPs) and patients improves patient satisfaction and health outcomes.4,7 However, communication skills are often embedded in the hidden curriculum,⁸ meaning that they are acquired informally rather than through structured and systematic training. Most communication models and frameworks for HCPs focus on adult patients, such as the Calgary-Cambridge Guide to the Medical Interview or the SPIKES model.^{9 10} In paediatric care, the deliberate use of communication skills is particularly important, as contextual factors that impact communication with patients can vary widely, including the patient’s age, stage of development and language skills.¹¹ Paediatric HCPs must also engage with both patients and parents in a triadic relationship, which makes communication even more complex.^{12 13}

Child-centred communication promotes the active participation of paediatric patients in treatment and care.¹⁴ Children’s right to participation is a fundamental principle outlined in the United Nations Convention on the Rights of the Child,¹⁵ which emphasises direct communication with children rather than communicating through their parents. Davison et al’s guide for child-centred communication focuses on strategies for getting to know the child, engaging them in conversations and involving them in their own treatment and care.¹⁶ One of the strategies in child-centred communication is play, which can aid HCPs in their communication with paediatric patients and promote participation, especially with younger children.^{17 18}

Previous educational interventions on communication and play

Despite a growing recognition of child-centred communication, relevant training for paediatric HCPs is limited and rarely evaluated systematically. Various reviews exploring educational programmes for paediatric HCPs on communication and patient-centred approaches, including the use of play, indicate that existing programmes vary widely in design and duration.19,22 Most programmes target undergraduate students or a few professional groups, often doctors and nurses, with limited emphasis on interprofessional approaches. Further, the reviews report that the programmes are often vaguely described and evaluated without control groups or validated outcome measures.

Self-efficacy as an outcome measure in communication training

Because communication skills are often part of the hidden curriculum rather than formally taught, HCPs may lack confidence when communicating with paediatric patients. A study involving HCPs from seven European countries found that over 40% had never received formal training in communication, which was perceived to be one of the most important barriers to effective patient communication.²³ Several studies have shown that communication skills training can improve HCPs’ self-efficacy in communicating with patients,24,32 but only a few have been conducted in paediatric settings. Self-efficacy is defined as the individual’s confidence in their own capability to successfully perform a given task and is a recognised measure of behaviour change.³³ It has proven to be a useful measure of HCPs’ perceived competence in applying communication skills, and research has demonstrated an association between self-efficacy and actual performance.^{34 35}

Rationale for testing two educational interventions of different durations

A common barrier to continuing professional development in communication is the limited amount of time and capacity available to give HCPs time off from their clinical duties.³⁶ This emphasises the importance of exploring educational interventions of varying duration, as duration not only influences the feasibility but also affects the instructional design and learning strategies. While shorter interventions may be more feasible, longer interventions can incorporate a wider range of learning strategies and potentially provide more comprehensive coverage of the content. Although few reviews have evaluated the impact of the duration of educational interventions, two reviews on educational interventions for HCPs and medical students suggest that the duration and frequency of educational interventions may not have any significant impact on their effectiveness.^{37 38} However, limited knowledge is available about how various intervention designs and durations influence HCPs’ self-efficacy, motivation to engage in training and practical skill application in paediatric communication training.

Pilot study

This study explores the outcomes of an educational programme called ‘Communication and play with children and adolescents in the healthcare setting’.³⁹ We conducted a pilot study from June to September 2024. Sixty-nine HCPs were recruited from the Department of Paediatric Surgery at Copenhagen University Hospital (Rigshospitalet) to participate in educational interventions lasting 2 hours. The participants included nurses, doctors, physiotherapists, educators, medical secretaries and a priest, all of whom had daily contact with children and adolescents in the hospital. They were asked to complete a questionnaire before and after the intervention. Descriptive statistics based on 44 participants who completed both the pre- and post-intervention questionnaires showed increased self-efficacy and self-perceived knowledge about age-appropriate communication.

Study aim

The aim of this study is to compare the effects of a 45 min and a 3-hour educational intervention for HCPs on age-appropriate communication and the use of play in clinical paediatric practice.

For the primary aim, we will test the hypothesis that:

• A 45-min educational intervention is non-inferior (non-inferiority margin 0.25) to a 3-hour intervention in improving participants' self-efficacy 12 weeks post-intervention

Methods and analysis

Trial design

We will conduct a single-centre, randomised, controlled, two-arm, non-inferiority trial to evaluate whether the 45-min educational intervention is comparable to the 3-hour educational intervention for paediatric HCPs.⁴⁰ The study adheres to the Standard Protocol Items: Recommendations for Interventional Trials statement on clinical trial protocols (online supplemental material A).⁴¹

Study setting

This study will be conducted at Rigshospitalet in Copenhagen, Denmark.

Participants and recruitment

All HCPs who are formally employed by the Department of Paediatrics and Adolescent Medicine at Rigshospitalet and who have direct patient contact will be eligible to participate in the study (table 1). Potential participants will be identified by their respective leaders in February and March 2025 through a recruitment process involving all staff groups in the department. The number of participants invited from each group will be based on the size of that group, to ensure broad interprofessional representation that reflects the department’s clinical diversity. For professions with smaller numbers of staff members, such as trainee doctors, physiotherapists, occupational therapists, dietitians, social workers and medical secretaries, all staff members employed during the intervention period will be invited to participate. For nurses, who represent the largest staff group in the department, we aim to invite one-third of the total staff group. Head nurses will be asked to provide around one-third of the nurses employed in each unit to ensure an equal representation across nursing teams. If the initial recruitment does not meet the target sample size, we will extend invitations to additional nurses. To ensure departmental and unit-level support, preparatory meetings will be held with relevant management from different professions. All participants will be thoroughly informed about the study, and written informed consent will be obtained before data collection begins by the principal investigator (JT) (online supplemental material B).

Table 1. Inclusion and exclusion criteria.

Inclusion criteria	Exclusion criteria
HCP formally employed by the Department of Paediatrics and Adolescent Medicine with patient contact Provision of signed informed consent before randomisation	Staff taking part in planning of the intervention Lack of informed consent

HCP, healthcare professional.

Randomisation

Eligible participants will be randomly allocated 1:1 to either a 45-min educational intervention or a 3-hour educational intervention using computer-generated block randomisation through Research Electronic Data Capture (REDCap) tools.⁴² The randomisation process will be stratified by healthcare profession to ensure that the allocated participants for each educational intervention are interprofessional. An external partner not involved in the study will create the randomisation algorithm and block sizes. The allocation list will be stored and concealed in REDCap. The principal investigator (JT) will be responsible for enrolling participants and entering their information.

Intervention

We will evaluate an educational programme called ‘Communication and play with children and adolescents in the healthcare setting’,³⁹ which focuses on age-appropriate communication with paediatric patients, including the deliberate use of play. To structure the development of the educational programme, we applied Kern’s six-step approach for curriculum development.⁴³ We conducted a general and targeted needs assessment, including a review of educational programmes on patient- and family-centred care,²⁰ as well as educational programmes focusing on the use of play in paediatric practice.²¹ We identified the overall aims (box 1) included in the educational curriculum through two preparatory research studies conducted by our own research team and engagement with stakeholders:

Box 1. Overall aims for the educational programme developed through workshops with healthcare professionals and management, as well as research input from healthcare professionals¹⁸ and paediatric patients⁴⁴.

Overall aims for the educational programme

1. Prepare for the specific situation and gain relevant knowledge about the needs and background of the child/adolescent and their parents.

2. Establish contact to initiate a relationship with the child/adolescent and their parents so that they feel safe and trust the healthcare professionals, which is often a crucial prerequisite for achieving a good outcome.

3. Create a shared understanding of the situation and prepare the child/adolescent and their parents for examinations, procedures and tasks while helping them understand and manage their illness.

4. Involve the child/adolescent and their parents in examinations, procedures and tasks to help them feel more in control and able to manage their illness.

5. Wrap up in a thoughtful and affirming way that helps the child/adolescent and their parents express their thoughts and feelings.

6. Reflect on the encounter with the child/adolescent and their parents to improve and strengthen personal and professional development and to contribute to interdisciplinary collaboration and a feedback culture.

• A Delphi study with 45 HCPs from 10 different countries.¹⁸

• A mixed methods study with 64 children and adolescents aged 3–18 years.⁴⁴

• Six workshops attended by approximately 25 interprofessional HCPs, one designer, two project managers and two educators.

• Five meetings with management organised in an interprofessional steering committee.

The aims and content of the educational programme are based on a communication model developed by our research team, which comprises six stages: preparation, contact, understanding, action, closure, and reflection and feedback (figure 1). The communication model builds on existing models and literature^{9 14 16 45} and was developed to address the communicative needs of paediatric patients. To support learning, a website containing written materials and a web app have been developed,³⁹ both of which will be accessible to the study participants. These resources present a schematic overview of communication with children and adolescents from different age groups, as well as competencies, to provide guidance on each of the communication model’s six stages.

Figure 1. Communication model for paediatric healthcare professionals comprising six stages.

While the initial development phase informed the formulation of aims and objectives for the educational programme, the data collected in the current study contribute to support the evaluation and feasibility for broader implementation. This is done by comparing two distinct educational interventions, both based on the same communication model that was tested in our 2-hour pilot intervention. In the pilot, we found that a 2-hour intervention left a limited amount of time available for group exercises and follow-up discussions. To address this, we will extend the intervention to 3 hours for the current study. The extended 3-hour format will be compared with a condensed 45-min version. This shorter format was selected as a comparator to assess the potential effectiveness and feasibility of a brief intervention that may be more easily integrated into time-constrained clinical environments with limited opportunities for staff training. While both interventions include didactic learning, reflection and discussions, these elements differ in depth and structure. The 3-hour intervention offers more time for interaction and includes role-play to allow the participants to engage more actively with the communication material. All interventions will be facilitated by the same interdisciplinary group of five HCPs from Rigshospitalet (doctors, nurses and researchers) between March and May 2025.

45-min educational intervention

The 45-min intervention will introduce paediatric communication and the use of play in paediatric clinical practice, followed by one or two reflection exercises and some cases of clinical encounters and situations. The intervention will conclude with a brief round of final remarks and takeaways. Most of the intervention will take place in plenary, but participants will be encouraged to share their own experiences and engage in discussions throughout the intervention.

3-hour educational intervention

In the 3-hour intervention, participants will be introduced to paediatric communication and the use of play in paediatric clinical practice, followed by reflection exercises. The participants will then be divided into smaller interprofessional groups to engage in role-play, which is an experiential learning method that focuses attention on the interaction of participants with one another by incorporating real-life scenarios.^{46 47} This approach allows participants to practise communication techniques and reflect on experiences from their own and other participants’ perspectives. Role-play is widely recognised as an effective teaching method for communication skills in healthcare education.^{48 49}

To support this activity, participants will receive a manual describing what role-play involves. They will be encouraged to do role-play scenarios based on their own clinical experiences, ensuring that the activity reflects realistic and contextually relevant clinical encounters with paediatric patients. Each group will consist of five to six HCPs who will rotate through four roles: one participant acting as the HCP, one as parent, another as the patient and the remaining as observers. The observers’ role is to carefully assess the interaction and provide feedback. After the role-play, participants will engage in a plenary discussion to reflect on the activities before ending the intervention with final remarks and takeaways. Table 2 provides an overview of the content for the two interventions.

Table 2. Overview of the content of the two educational interventions.

Content of 45-min intervention	Content of 3-hour intervention
Short introduction to the topic Reflection exercises Cases and discussion in plenum Final remarks and takeaways	Introduction to the topic Reflection exercises Role-play activities Break Role-play activities Reflection on role-play and discussion in plenum Final remarks and takeaways

Data collection

Data will be collected at three time points from March 2025 to October 2025 using REDCap tools.⁴² On entering the study, the participating HCPs will be asked to complete the baseline questionnaire, which includes their age, gender, profession and years of professional experience. Follow-up questionnaires will be distributed immediately after the intervention and 12 weeks after the intervention. Participants will receive the online questionnaires as a unique link sent to their e-mail distributed through REDCap. Weekly reminders will be sent to increase response rates.

Outcomes

Primary outcome

The primary outcome is participants’ self-efficacy in patient-centredness 12 weeks post-intervention. Self-efficacy will be measured using a questionnaire with 10 items employed in the pilot study. The items are adapted from questions of the Danish version of the validated instrument Self-efficacy in Patient Centeredness Questionnaire (SEPCQ-27), which was originally developed to assess HCPs’ confidence in their own ability to relate to and communicate with patients.⁵⁰ As the SEPCQ-27 does not specifically target paediatric patients, our questionnaire contains items relevant to the paediatric context and is aligned with the stages in the communication model used in the educational intervention (see figure 1). Each item is scored on a 5-point Likert scale, with higher scores indicating greater self-efficacy, and the final self-efficacy score is calculated as the mean of the 10 items.

Secondary outcomes

Self-efficacy

Self-efficacy will be assessed immediately after the intervention using the same 10-item questionnaire employed for the primary outcome.

Motivation

Intrinsic motivation to engage in the educational activity will be measured using the validated Intrinsic Motivation Inventory (IMI),⁵¹ which is a multidimensional self-report questionnaire designed to assess the subjective experience related to a target activity. We use the seven-item Interest/Enjoyment subdomain, which is considered to be the direct self-report measure of intrinsic motivation for an activity recently completed.⁵² A Danish translation of IMI is available.⁵³

Self-evaluated knowledge about age-appropriate communication

The participants’ self-perceived knowledge about paediatric communication will be assessed using a single item that was also part of the pilot study: ‘How do you rate your knowledge about age-appropriate communication with children and adolescents?’. The item contains close-ended response options ranging from ‘no knowledge’ to ‘very high knowledge’.

Cognitive load

Cognitive load during the intervention will be measured using the Paas Mental Effort Rating Scale,⁵⁴ which is a validated, single-item measure that asks participants to rate their perceived mental effort ranging from ‘very, very low’ to ‘very, very high’. The scale is one of the most widely used tools for assessing cognitive load, as it offers a simple way to assess the perceived mental effort invested in an activity.^{55 56}

Satisfaction

Five items will evaluate participant satisfaction with the interventions, focusing on general feedback, clinical relevance, overall quality and the participants’ willingness to recommend the interventions to other HCPs.

Impact on individual practice and training needs

The impact on individual practice and training needs will be evaluated using four items that examine whether participants changed their own practice, engaged with further reading or identified a need for more training.

Study measurements

Self-efficacy and knowledge about age-appropriate communication will be measured at every time point. Motivation, cognitive load and satisfaction will be measured immediately after the educational intervention. Impact on individual practice and training needs will be measured at the 12-week follow-up (table 3). The full set of questionnaires and items used in this study can be found in online supplemental material C.

Table 3. Study measurements and measurement points.

Study measurements		Measurement points
Assessment	Outcome measure	Baseline	Immediately after intervention	12-week follow-up
Self-efficacy	Mean of 10 items on a 5-point scale*	X	X	X
Intrinsic motivation	Intrinsic Motivation Inventory Sub-scale: Interest/enjoyment (mean of seven items on a 7-point scale)51		X
Self-evaluated knowledge about age-appropriate communication	One item on a 5-point scale	X	X	X
Cognitive load	Mental effort rating scale (one item on a 9-point scale)54		X
Satisfaction	Four items on a 5-point scale and one open-ended item		X
Impact on individual practice and training needs	Four items on a 5-point scale			X

^*Some items are inspired by questions from the Danish version of the validated instrument Self-efficacy in Patient Centeredness Questionnaire.50

Blinding

Due to the nature of the study design, blinding of research team members and participants is not possible. The statistician and researchers conducting the analyses will be blinded to participant allocation.

Sample size and power considerations

The sample size calculation assumes that the 45-min intervention is as effective as the 3-hour intervention for the primary outcome (self-efficacy) measured at 12 weeks. We set a non-inferiority margin of 0.25 points, which means that the mean self-efficacy score for the 45-min intervention can be up to 0.25 points lower than that of the 3-hour intervention without being considered inferior. In accordance with the guidance from The European Medicines Agency,⁵⁷ the margin was determined through a combination of clinical judgement and statistical reasoning. As no historical data exist on the self-efficacy scale applied in this study, we used data from our pilot study (single group pre-post-test), in which we observed a SD of 0.45 in self-efficacy scores following a 2 hour educational intervention (unpublished data). The chosen margin of 0.25 corresponds to a 1-point lower rating on one out of every four items on the self-efficacy scale. This threshold was considered the largest acceptable difference at which the 45-min intervention would still be regarded as clinically relevant in comparison to the 3-hour intervention. Based on a one-sided two-sample t-test with a margin of 0.25, an alpha of 0.025,⁵⁷ a power of 80%, and the SD of 0.45 derived from the pilot study, the required sample size is 52 participants per group. Since the intervention will be conducted in clusters of 25 participants, the sample size calculation is adjusted for cluster randomisation by multiplying by the design effect, calculated as 1 + (cluster size – 1) × intracluster correlation coefficient (ICC).⁵⁸ We assume an ICC of 0.01,⁵⁹ resulting in a design effect of 1.24 and an adjusted sample size of 65 per group. Accounting for 10% missing responses, the final required sample size is 72 per group. We plan to include approximately 150 participants, or 75 participants per intervention consisting of three teams with 25 participants per team. The power calculation was performed using SAS V.9.4.⁶⁰

Statistical analyses

We will present descriptive statistics on baseline demographics for each group. Quantitative variables will be reported using median and IQR, while categorical variables are presented as counts and percentages.

Descriptive statistics for all outcomes will be presented at each time point using the mean, SD and/or median and IQR. The effect of the intervention will be assessed at the individual level, with all outcomes (table 3) treated as interval scale and analysed using parametric methods. For outcomes measured only once, the mean difference between the two intervention groups will be assessed in a linear mixed model with a random cluster effect to account for clustering within teams. For outcomes measured at baseline and multiple times post-intervention, comparisons will be adjusted for the baseline value using analysis of covariance (ANCOVA) and will include both a random cluster effect and a random individual effect to account for correlation within individuals. All analyses will be adjusted for the stratification variable (HCP).

In the analysis of the outcomes measured three times (including self-efficacy—the primary outcome), measurements on participants responding only to the baseline questionnaire or only at the two post-intervention questionnaires will be excluded from the analyses. A low amount of missing data is expected for outcomes measured before and immediately after the intervention, while approximately 10% missingness is expected for outcomes measured 12 weeks post-intervention. To maximise response rates, weekly reminders will be sent, and participants who do not respond online will be approached in the hospital and offered a paper-based option. For the primary outcome, missingness is assumed to be MAR (missing at random) given baseline measurements. However, if missingness exceeds expectations, we will consider applying missing data techniques for all outcomes (eg, multilevel multiple imputation).

For all outcomes, 95% two-sided confidence intervals will be reported. For the primary outcome, self-efficacy measured at 12 weeks after the intervention, non-inferiority will be concluded if the upper limit of the 95% CI for the mean difference does not exceed the non-inferiority margin of 0.25. Analyses will be conducted according to the intention-to-treat principle. In separate analyses, we will consider only individuals who have participated in (1) the full intervention (ie, those who did not leave the teaching session) and (2) at least part of the intervention. All participants who leave during the intervention will be registered by the principal investigator (JT). Calculations will be performed using the statistical software R and/or SAS.^{60 61} Content analysis will be used to analyse the open-ended question responses.⁶²

Ethics and dissemination

This study, which is registered at ClinicalTrials.gov (NCT06859632), adheres to the Declaration of Helsinki. The Danish Data Protection Agency approved the study (P-2020–1144), and the Scientific Ethics Committees for the Capital Region of Denmark deemed the study exempt from requiring ethics approval (H-21028050). Participation will be voluntary, and both interventions will be conducted during working hours. There will be no cost for the participants. The principal contributor will obtain signed, informed consent from participants before enrolment. Participants will be free to withdraw from the study at any time without repercussions, and the intervention will be discontinued if their consent is withdrawn.

All data will be stored in a secure database (REDCap) to ensure participant confidentiality and undergo pseudonymisation before being imported into the analysis software. The final trial data will only be accessible to the study investigators for statistical analysis. Any modifications to the protocol or significant changes to trial procedures will be updated on ClinicalTrials.gov. The results from this trial will be submitted for publication in peer-reviewed journals, and the key findings will be presented at national and international conferences. Participants will also receive a summary of the trial results.

Patient and public involvement statement

The intervention was developed using a participatory approach involving a broad representation of HCPs and management from Rigshospitalet. In the development phase, we held six meetings/workshops with HCPs, designers, project managers and educators. We also included the perspectives of paediatric patients⁴⁴ and an international panel of HCPs from ten different countries.¹⁸

Data sharing

De-identified data generated during the main study will be made available from the corresponding author (ORCID: 0000-0002-0093-8555) upon reasonable request, with an approved proposal and data use agreement. However, data from the pilot study are not available due to ethical and confidentiality constraints.

Discussion

The primary aim of this RCT is to test if a 45-min educational intervention on communication and play with children and adolescents is as effective as a 3-hour educational intervention in improving HCPs’ self-efficacy. With a global shortage of healthcare workers,⁶³ there is a need to compare educational interventions for HCPs of various durations and designs. Few previous studies evaluating educational programmes on communication and play have used randomised trial designs, and reviews have recommended employing RCTs to evaluate their effectiveness.^{20 21}

The current study will provide valuable insights into the implementation of a 45-min versus a 3-hour educational intervention by evaluating the participants’ self-efficacy, in addition to various other outcomes, including their motivation to engage in education and changes in individual practice observed at 12 weeks. Understanding the participants’ motivation and changes in their own practice is critical, as many healthcare interventions are never adopted into general use after being studied.⁶⁴ Successful and sustainable implementation of healthcare interventions is influenced by the organisational context and factors such as the interventions’ feasibility, fidelity and acceptability.⁶⁵ To further explore these factors, we will conduct a follow-up focus group study in the future. This qualitative approach will provide an in-depth exploration of the perceived benefits, challenges and practical considerations involved in implementing the interventions, as well as their potential for long-term integration within the organisation. A future and ultimate step may be to evaluate the effect of the intervention on children’s and adolescent’s hospital experiences and symptom burden.