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Development and Evaluation of a Immobilization Support System for Pediatric Proton Therapy

Development and Evaluation of a Immobilization Support System for Pediatric Proton Therapy

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT1032250257
Enrollment
10
Registered
2025-07-29
Start date
2025-09-01
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

Not applicable (Healthy volunteers only) Not Applicable

Interventions

Participants will be asked to remain still for approximately 20 minutes under two conditions: with and without the immobilization support system. Heart rate will be monitored during the intervention.
immobilization support, saliva collection, heart rate monitoring

Sponsors

Mori Yutaro
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Healthy children aged 7 to 9 years with no visual impairment and binocular visual acuity of 0.6 or higher; main caregivers (e.g., parents or legal guardians) who can provide emotional support and participate by supplying video content for the head-mounted display (HMD); written informed consent obtained from the caregivers; availability to participate in the study schedule; not using visual correction devices (e.g., glasses or contact lenses) that interfere with HoloLens 2 gaze calibration (calibration must be confirmed in advance); visual acuity will be confirmed by school health records or a simple vision test (e.g., Landolt ring).

Exclusion criteria

Exclusion criteria: Individuals who are judged to have difficulty participating in the study due to mental or physical reasons; Individuals for whom the investigator determines that participation may adversely affect their health; Individuals currently participating in other clinical studies.

Design outcomes

Primary

MeasureTime frame
Primary outcome: Change in body movement frequency during intervention (measured via motion tracking or gaze stability)

Secondary

MeasureTime frame
Primary outcome: Change in salivary cortisol levels before and after use of the support system

Contacts

Public ContactYasuwo Ide

Tsukuba International University

y-ide@tius.ac.jp+81-298266000

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026