Various conditions are possible
Conditions
Interventions
Group 1: Arm 1 (Control): Routine – “Standard Coaching”. Standard coaching includes, for example, a trial session in the scanner and video entertainment in the scanner. For the purposes of the study,
Sponsors
Universitätsklinikum Tübingen, Radiologie, Diagnostische & Interventionelle Radiologie, Kinderradiologie
Eligibility
Sex/Gender
All
Age
3 Years to 6 Years
Inclusion criteria
Inclusion criteria: •Male and female patients aged 3 to 6 years and their legal guardians •Referral with a clinical indication for an MRI (with contrast enhancement, if necessary) •Written consent to participate in the study from the legal guardian
Exclusion criteria
Exclusion criteria: •No written consent to the study from the parents/legal guardians
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The co-primary endpoints are: •Development of a potentially prognostic developmental score regarding the need for sedation in 3- to 6-year-old children for further validation (questionnaire surveys at study enrollment). •Comparison of the number of anesthetic procedures required between Arm A and Arm B. | — |
Secondary
| Measure | Time frame |
|---|---|
| •Comparison of the number of interrupted scans between Arm A and Arm B, •Number of failed attempts (without anesthesia) , •Comparison of total MRI scan times in minutes (“room time”) between Arm A and Arm B, as well as between children under anesthesia and those without anesthesia, •Comparison of image quality and diagnostic value of MRI images between Arm A and Arm B, as well as between children under anesthesia and those without anesthesia, e.g., occurrence of motion artifacts. | — |
Countries
Germany
Contacts
Public ContactJürgen Schäfer
Universitätsklinikum Tübingen, Radiologie, Diagnostische & Interventionelle Radiologie, Kinderradiologie
Outcome results
None listed