← Back to homepage

Research & Professional Background

Evidence, experience and responsible interpretation.

This page presents the research, professional observations, institutional experience, methodological work and scientific context behind SkillsPals and Marokbaba.

Different sources answer different questions. We therefore identify what each source can tell us, what it cannot prove, and where further evidence is still being developed.

How to read the evidence

Evidence type matters.

Clinical research, exploratory academic work, professional observation and institutional experience are not interchangeable. These labels make the basis and limits of each statement visible.

Exploratory research

Device-specific academic work designed to explore questions and generate evidence.

Professional report

Structured observations from professional practice, without a controlled comparator.

Institutional experience

Documented real-world use in an organisation or care environment.

Methodological framework

Structured activities and safeguards developed for professional use.

Scientific literature

Peer-reviewed context relevant to the rationale, but not direct proof of SkillsPals outcomes.

Technical evidence

Laboratory, material and manufacturing evidence within its documented scope.

Ongoing work

Research or evidence development that is not presented as a completed result.

Evidence overview

A layered evidence base.

The current evidence supports careful evaluation of complementary, professionally guided uses. It does not support claims of guaranteed outcomes, diagnosis or stand-alone treatment.

Completed academic / exploratory work

Design, use experience and subjective processes

What it tells us: Device-specific work describes the multidisciplinary concept, professional reception and selected tactile-use experiences.

What it does not prove: Controlled paediatric clinical effectiveness or long-term outcomes.

Professional observations

Paediatric examination settings

What it tells us: Professional reports describe playful contact, attention guidance and child involvement in everyday practice.

What it does not prove: Comparative effect size, causality or universal benefit.

Institutional experience

Emergency and care environments

What it tells us: Documented use shows how the figures have been integrated into real-world professional settings.

What it does not prove: Clinical efficacy or a new medical intended purpose.

Methodological frameworks

Structured, adaptable professional activities

What it tells us: Professional materials provide activity structures, consent principles and competence boundaries.

What it does not prove: Empirical treatment effectiveness.

Scientific literature

Sensory activity, attention and therapeutic play

What it tells us: Published research provides a broader scientific and methodological rationale.

What it does not prove: That findings from other interventions automatically apply to SkillsPals.

Technical / safety evidence

Materials, mechanical properties and documented controls

What it tells us: Laboratory and material records support defined technical and toy-safety characteristics within the tested scope.

What it does not prove: Complete MDR conformity or clinical benefit.

Completed academic and exploratory work

Device-specific work, presented with its limits.

Exploratory research2025

Multidisciplinary design and application study

Aim
To examine the design and application background of Marokbaba through a multidisciplinary perspective.
Setting
Academic student research using questionnaire-based information and professional feedback.
Method
Conceptual, questionnaire-based and professional-response material.
Main contribution
Documents the development concept and professional reception of the product system.

What it tells usThe work supports understanding of the concept, its multidisciplinary roots and professional relevance.

What it does not proveIt is not a controlled paediatric effectiveness study.

Manufacturer-held academic document. Full-text public access and publication permissions are not confirmed on this page.

Exploratory research2026

Exploratory psychological pilot on recalled crisis experience

Aim
To explore subjective experiences associated with tactile use of Marokbaba while participants recalled a resolved crisis experience.
Population
20 adults with psychological knowledge, aged 26–62 years; 11 women and 9 men. The study did not take place during acute crisis care.
Method
Self-report scales, structured self-observation and semi-structured interviews.
Main observation
The author categorised 12 participants as showing a marked subjective change, 7 a moderate change and 1 a mild change. Reported themes included bodily-sensory stabilisation, emotional processing, attentional reorganisation and symbolic resources.
Safety-relevant observation
Two participants reported increased emotional intensity, reinforcing the importance of voluntary, observable and interruptible use.

What it tells usThe pilot provides device-specific qualitative evidence about immediate subjective processes in an adult exploratory setting.

What it does not proveIt does not establish treatment effect, paediatric outcomes, acute-crisis effectiveness or generalisable clinical efficacy.

Manufacturer-held academic document. Bibliographic details are retained internally; a public full-text link is not provided.

Professional and institutional experience

Documented use in practice.

These examples show how professionals and institutions have used or adapted Marokbaba. Their evidence types remain explicit.

Professional report

Paediatric practice and examination cooperation

A 2026 paediatric practice report describes children choosing and holding a figure, and a figure being “examined” first during routine encounters including ear, throat and chest examination and vaccination contexts.

Interpretation: favourable observations of engagement and cooperation in one practice; not a controlled clinical trial.

Institutional experience

Emergency care

The Hungarian National Ambulance Service publicly reported the placement of 100 Marokbaba figures across 50 units for use in contact, communication and attention guidance when caring for children.

Interpretation: documented real-world institutional use; no comparative clinical outcome data were reported.

Read the public institutional source ↗
Institutional experience

Older adult and dementia-care exploration

An institutional adaptation report describes deployment across eight settings and more detailed experience in dementia care, including observations of tactile activity, interest, participation, enjoyment and connection.

Interpretation: exploratory professional and methodological experience; not measured clinical outcomes and not a separate declared medical intended purpose.

Evidence-informed practice

Sensorimotor activities

The varied surfaces, shapes and separable components allow holding, rotating, repositioning, comparing, separating and reconnecting tasks within professionally guided activities.

Interpretation: functional affordances and professional applicability; not a guarantee of a specific developmental or therapeutic result.

Exploratory research

Current emotional and behavioural self-regulation

Device-specific qualitative evidence and professional materials support evaluating voluntary tactile activity as a complementary option for current, situation-specific self-regulation.

Interpretation: a bounded, complementary use; not evidence that the product treats trauma, anxiety or another condition.

Methodological materials

Structure without overclaiming.

Methodological resources translate professional experience into adaptable activities. They are presented as practice frameworks, not as efficacy studies or mandatory clinical protocols.

Methodological framework

Trauma-sensitive professional practice

A 35-page professional resource sets out device-based activities for children aged 4–11, adolescents aged 12–17 and adults affected by relational violence.

  • Voluntary choice and the right to stop
  • Present orientation and recognition of emotions
  • Respect for personal boundaries
  • Use within the practitioner’s competence

Limit: a structured professional resource, not an empirical clinical effectiveness study.

Practice material

Developmental and institutional activities

Product-based activity materials offer ideas for tactile exploration, manipulation, matching, shared attention and guided play. Professionals remain responsible for selecting an appropriate task, pace and level of support.

Limit: activity guidance does not replace assessment, diagnosis, treatment planning or an institution’s own protocol.

Scientific background

Context for the rationale — not product-specific proof.

Published literature informs the questions asked about sensory activity, therapeutic play, attention and procedural distress. Its findings are not automatically transferred to SkillsPals.

Sensory and sensorimotor approaches

Systematic reviews and controlled studies report promising but heterogeneous findings across selected sensory and occupational-therapy approaches. Interventions are complex, individualised and methodologically distinct from testing one tactile product.

Procedural distress and attention

Paediatric literature supports evaluating distraction, therapeutic play and other psychological strategies around selected procedures, while also showing variation in evidence quality and intervention design.

Responsible translation

Broader literature helps define plausible professional contexts and research questions. Product-specific claims still require evidence directly relevant to the product, target population and intended use.

Important distinction: evidence for a broader therapeutic approach is not evidence that SkillsPals independently reproduces that approach’s outcomes.

Ongoing work and evidence development

Evidence is expected to evolve.

No public research count is used while the research master register is being harmonised.

Ongoing work

Structured paediatric observations

Practice observations may contribute additional device-specific information when methods, outcomes and permissions are defined.

Ongoing work

Institutional feedback

Professional and organisational experience is being treated as a source for learning, not automatically as clinical validation.

Ongoing work

PMS and PMCF planning

Feedback, complaints, professional reports and future follow-up data are being structured for lifecycle review within the separate MDR pathway.

Regulatory status

Two statuses, clearly separated.

Current market status

Multisensory developmental toy

SkillsPals / Marokbaba products presented for current purchase are toys with product-specific age grading, instructions for use and documented toy-safety evidence.

Professional use does not by itself change the product’s current regulatory status.

Product Safety & Instructions

Separate pathway in progress

EU MDR Class I technical documentation and conformity work

Marokbaba Kft. is preparing technical documentation and carrying out related conformity work for a possible future Class I medical-device application.

This work is in progress. SkillsPals is not currently presented as a CE-marked medical device.

An EUDAMED Actor ID / SRN identifies the economic operator. It is not, by itself, device registration, a declaration of conformity or evidence that a medical-device CE pathway has been completed.

Responsible claims

Public communication does not ascribe functions the product does not have, create a false impression of treatment or diagnosis, omit likely risks, or suggest uses beyond an assessed intended purpose.

Before a future medical-device launch

The applicable Class I pathway includes clinical evaluation, technical documentation, risk and quality processes, an EU declaration of conformity, CE marking and the relevant manufacturer/device registration steps.

Not medical advice

This page describes an evidence base. It does not provide diagnostic or treatment advice and does not replace professional judgement, local protocols or required care.

References and source types

Public sources and manufacturer-held evidence.

Public links are provided where a source is openly available. Internal academic, practice and methodological documents are described by source type where public-access or publication permission has not been confirmed.

Selected public scientific and institutional sources

  1. May-Benson, T. A. & Koomar, J. A. (2010). Systematic review of interventions using a sensory integrative approach for children ↗.
  2. Schaaf, R. C. et al. (2014). An intervention for sensory difficulties in children with autism: a randomized trial ↗.
  3. Schoen, S. A. et al. (2019). A systematic review of Ayres Sensory Integration intervention for children with autism ↗.
  4. Piller, A. et al. (2025). Systematic review of sensory-based interventions for children and youth (2015–2024) ↗.
  5. Birnie, K. A. et al. (2018). Psychological interventions for needle-related procedural pain and distress in children and adolescents ↗.
  6. Pontes, J. E. D. et al. (2015). Therapeutic play: preparing the child for vaccination ↗.
  7. Shen, Y. et al. (2023). Active versus passive distraction for reducing procedural pain and distress in children ↗.
  8. Hungarian National Ambulance Service (2026). Public announcement on institutional use of Marokbaba ↗.

Regulatory sources

  1. Regulation (EU) 2017/745 on medical devices ↗.
  2. MDCG 2019-15 rev.1: Guidance notes for manufacturers of Class I medical devices ↗.
  3. European Commission: EUDAMED Actor registration and SRN ↗.

Manufacturer-held source types

  • Multidisciplinary student research (2025)
  • Device-specific exploratory adult psychological pilot (2026)
  • Paediatric professional practice report (2026)
  • Older-adult and dementia-care institutional adaptation report (2026)
  • Trauma-sensitive professional methodology
  • Clinical evaluation, PMS/PMCF, risk and technical evidence files

These sources are not linked where the full document is internal or public-use permission has not been confirmed.

Professional contact

Research, practice or partnership enquiry?

Contact the Marokbaba team to discuss professional use, research collaboration, institutional learning or the regulatory pathway.