Effect of the MIROKI Companion Robot on Anxiety in Pediatric Radiotherapy
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age4+
SponsorInstitut du Cancer de Montpellier - Val d'Aurelle
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
Parent of a child enrolled in the study.
Able to speak French.
Willing to participate in the study. Parent Exclusion Criteria
Trial population
Participants will be recruited from the pediatric radiotherapy unit at Montpellier Cancer Institute (ICM).During the initial consultation to initiate radiotherapy treatment at ICM, the investigator physician will present the KOKORO-01 study. They will answer all questions regarding its procedures and will provide the parents or legal representative with the information sheet and consent form. Parents or the legal representative will have at least one week to consider participation, during which they may ask any questions they wish.
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
To evaluate the immediate intra-individual effect of MIROKI on a physiological marker of anxiety in children undergoing radiotherapy.
The child's anxiety level measured through an objective assessment of heart rate (bpm sensor).
Time frame
During the treatment, across the 6 radiotherapy sessionsSecondary outcomes
1
Evaluate the immediate intra-individual effect of MIROKI in children on: Psychological distress level
Distress questionnaire (PedsQL 3.0 Cancer Module score, Varni et al.)
Time frame
administered before the start of treatment and after completion of treatment2
Evaluate the immediate intra-individual effect of MIROKI in children on development of attachment and reassurance
Daily distress VAS (Peds-DTRS score, Patel et al., 2011, 2021) and standardized real-time observation using an observational grid.
Time frame
Before, during, and after treatment3
Evaluate the satisfaction with care (radiotherapy at ICM) at the end of treatment
Post-treatment interview (thematic and lexico-metric analysis).
Time frame
At the end of treatment4
Evaluate the impact of MIROKI on the radiotherapy process: Setup time during sessions in the radiotherapy room
Time frame
From the beginning to the end of the treatment courseSponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: