Effect of the MIROKI Companion Robot on Anxiety in Pediatric Radiotherapy (KOKORO01)
9. juni 2026 oppdatert av: Institut du Cancer de Montpellier - Val d'Aurelle
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.
Studieoversikt
Status
Har ikke rekruttert ennå
Studietype
Observasjonsmessig
Registrering (Antatt)
6
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Aurore MOUSSION
- Telefonnummer: +33 0467613102
- E-post: drci-icm105@icm.unicancer.fr
Studiesteder
-
-
Herault
-
Montpellier, Herault, Frankrike, 34298
- Julien Welmant
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
- Voksen
- Eldre voksen
Tar imot friske frivillige
Ja
Prøvetakingsmetode
Sannsynlighetsprøve
Studiepopulasjon
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.
Beskrivelse
Inclusion Criteria:
- 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.
Exclusion Criteria:
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
- 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.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
To evaluate the immediate intra-individual effect of MIROKI on a physiological marker of anxiety in children undergoing radiotherapy.
Tidsramme: During the treatment, across the 6 radiotherapy sessions
|
The child's anxiety level measured through an objective assessment of heart rate (bpm sensor).
|
During the treatment, across the 6 radiotherapy sessions
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Evaluate the immediate intra-individual effect of MIROKI in children on: Psychological distress level
Tidsramme: administered before the start of treatment and after completion of treatment
|
Distress questionnaire (PedsQL 3.0 Cancer Module score, Varni et al.)
|
administered before the start of treatment and after completion of treatment
|
|
Evaluate the immediate intra-individual effect of MIROKI in children on development of attachment and reassurance
Tidsramme: Before, during, and after treatment
|
Daily distress VAS (Peds-DTRS score, Patel et al., 2011, 2021) and standardized real-time observation using an observational grid.
|
Before, during, and after treatment
|
|
Evaluate the satisfaction with care (radiotherapy at ICM) at the end of treatment
Tidsramme: At the end of treatment
|
Post-treatment interview (thematic and lexico-metric analysis).
|
At the end of treatment
|
|
Evaluate the impact of MIROKI on the radiotherapy process: Setup time during sessions in the radiotherapy room
Tidsramme: From the beginning to the end of the treatment course
|
From the beginning to the end of the treatment course
|
|
|
Evaluate the impact of MIROKI on parents: - Anxiety level - Satisfaction with care at the end of treatment - Experience of the radiotherapy process at the end of treatment
Tidsramme: Before the start , during and after the treatment,
|
During treatment: - Daily anxiety VAS (daily DT score, Leclair et al., 2016; NCCN, 2025) After treatment: - Assessment of the radiotherapy experience and satisfaction with care with the robot, using the parent interview grid |
Before the start , during and after the treatment,
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Etterforskere
- Hovedetterforsker: Julien, Welmant, ICM Co. Ltd.
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Hjelpsomme linker
- Bamberger, K. T. (2016). The Application of Intensive Longitudinal Methods to Investigate Change: Stimulating the Field of Applied Family Research. Clinical Child and Family Psychology 1040 Review
- Dominique Interactif pour Adolescents-Révisé, dépression, comorbidité et suicidalité
- Prediction of compliance with MRI procedures among children of ages 3 years to 12 years
- Examining the perceived social support and psychological symptoms among adolescents with leukemia
- Pediatric radiotherapy preparation: a scoping review
- Consultation with children in hospital: children, parents' and nurses' perspectives
- The Family of Single-Case Experimental Designs
- Children's experiences and responses towards an intervention for psychological preparation for radiotherapy
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
1. juli 2026
Primær fullføring (Antatt)
1. juli 2027
Studiet fullført (Antatt)
1. juli 2027
Datoer for studieregistrering
Først innsendt
9. juni 2026
Først innsendt som oppfylte QC-kriteriene
9. juni 2026
Først lagt ut (Faktiske)
12. juni 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
12. juni 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
9. juni 2026
Sist bekreftet
1. juni 2026
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- PROICM 2026-01 KOK
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
JA
IPD-planbeskrivelse
All data will be available after publication of the results in peer-reviewed revues, and in national and international meetings.
It includes all de-identified participants' data, the study protocol, the statistical analysis plan and the clinical study report.
The corresponding author will provide data and datasets generated and/or analyzed during the study upon reasonable request.
IPD-delingstidsramme
Access to study data upon written detailed request sent to ICM, from 6 months until 5 years after publication of summary data.
Tilgangskriterier for IPD-deling
The data shared will be limit to that required for independent mandated verification of the published results, the applicant will need authorization from ICM for personal access, and data will only be transferred after signing of a data access agreement.
IPD-deling Støtteinformasjonstype
- STUDY_PROTOCOL
- SEVJE
- ICF
- CSR
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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