NCT07645950Not yet recruiting
Effect of the MIROKI Companion Robot on Anxiety in Pediatric Radiotherapy
Source: ClinicalTrials.gov · Last updated 12 Jun 2026
Brief summary (registry, in English)
Pediatric radiotherapy is an anxiety-provoking situation that can, on one hand, impair the child's cooperation and require sedation, and on the other hand,burden the care pathway by generating significant anxiety in both the child and their parents. Companion robots represent an innovative avenue for patient support, but they have never been evaluated in the context of radiotherapy. This study examines the effect of MIROKI, the first social robot capable of communication through a Large Multimodal Model (LMM), on children's state anxiety during radiotherapy. An experimental single-case design (SCED) will compare phases with and without the robot (withdrawal/reversal), both in the waiting room and in the irradiation bunker. The primary outcome variable is anxiety, assessed in several ways: through questionnaires at the beginning and end of treatment; through an objective measure of cardiac activity (heart rate in bpm) during the radiotherapy session, with or without the MIROKI robot; and through an observational grid assessing the child's behavior. The intensive repeated measure (bpm) constitutes the preferred variable in this SCED design, while behavioral observation and anxiety questionnaires will support interpretation. The results could pave the way for reducing sedation and improving the overall care pathway in pediatric radiotherapy.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 6 (estimated)
- First submitted
- 9 Jun 2026
- Start date
- 1 Jul 2026
- Primary completion date
- 31 Jul 2027
- Lead sponsor
- Institut du Cancer de Montpellier - Val d'Aurelle
- Diseases
- Childhood cancers
- NCT number
- NCT07645950
What you commit to
- Study type: Observational
- Planned participants: 6
- From 1 Jul 2026 to the primary completion date, 31 Jul 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 6\. Child with a diagnosed neurodevelopmental disorder as a comorbidity. 7. Child with postoperative cognitive sequelae that make interaction during care difficult (e.g., language impairment). 8. Total body irradiation. 9. Child under legal protection, unable to express assent, or presenting major difficulties in understanding the study information. Parent Inclusion Criteria
Other
- Parent of a child enrolled in the study.
- Able to speak French.
- Willing to participate in the study. Parent Exclusion Criteria
- 1\. Parents or legal representatives under legal protection, or presenting an inability to consent or to understand the study information, making it impossible to provide free and informed consent for the minor's participation.
Who the study is looking for
- Children aged 4 to 18 years, distributed across the following age groups: 4-7 years, 8-12 years, and 13-18 years.
- Child with an indication for radiotherapy treatment at ICM.
- Child who speaks French.
- Child accompanied by a parent or legal guardian who agrees to participate in the study and provide consent.
- Child covered by the French national health insurance system.
Age in the registry: 4 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Julien Welmant Coordinator of this site? Confirm its status | Montpellier | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.