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Feasibility study to evaluate the LUKA concept for child-friendly preparation and support during MRI examinations

Feasibility study to evaluate the LUKA concept for child-friendly preparation and support during MRI examinations - MaLUKA

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00040808
Enrollment
30
Registered
2026-06-30
Start date
2026-07-01
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patient information and anxiety reduction in children during MRI

Interventions

Group 1: Intervention Group 1: Preparation with LUKA
MRI monitoring via audio only, using the LUKA guided imagery exercise Group 2: Intervention Group 2: Preparation with LUKA
MRI support using the auditory and interactive LUKA guided imagery session. Group 3: Control group: Preparation according to hospital standards
MRI guidance provided only audibly using the LUKA guided imagery exercise.

Sponsors

Technische Universität München TUM
Lead Sponsor

Eligibility

Sex/Gender
All
Age
5 Years to 12 Years

Inclusion criteria

Inclusion criteria: - German-speaking children aged 5–12 - who are scheduled to undergo an MRI scan of the head and neck at Erlangen University Hospital - who have no prior experience with MRI scans

Exclusion criteria

Exclusion criteria: - Emergency MRI scans - Cognitive impairments that make it difficult to provide age-appropriate feedback - Intolerance to VR applications, motion sickness, epilepsy, or other relevant neurological conditions - Use of visual aids that cannot be worn during an MRI scan

Design outcomes

Primary

MeasureTime frame
- Acceptance/Satisfaction with LUKA Materials (Questionnaires 1, 3) - Technical and Organizational Feasibility (Questionnaires 1–3) - Potential for optimization (Questionnaires 1–3) - Anxiety assessment (adapted Scary Scale, Modified Yale Preoperative Anxiety Scale Short Form) - Knowledge assessment (Questionnaire 2) - Quality of examination (observation protocol) Timing of Data Collection: Questionnaire 1: After completing the preparation phase, parents and children provide feedback on the comprehensibility, usability, and acceptability of the material via the digitized Questionnaire 1 in the web app. Questionnaire 2: Questionnaire 2 is completed by all study groups on a provided tablet in the waiting room before and after the MRI scan. Questionnaire 3: This questionnaire is intended for the participating medical staff and is completed digitally after data collection is finished.

Secondary

MeasureTime frame
Assessment of initial evidence regarding the effectiveness of the LUKA approach in terms of knowledge transfer through education, anxiety reduction before and during the examination, and the quality of the examination, based on initial random samples

Countries

Germany

Contacts

Public ContactOliver Rompel

Pädiatrische Radiologie des Uniklinikums Erlangen

studienzentrale.dr@uk-erlangen.de+4991318545558

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Aug 10, 2026