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Augmented Reality to Reduce Pain During Botulinum Toxin Injections in Cerebral-palsied Children

NCT02596412 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2022-05-06

No results posted yet for this study

Summary

Children with cerebral palsy may benefit from treatment with botulinum toxin injections to decrease spasticity for improve function and quality of life. These injections cause repeated pain throughout childhood and may be the cause of post-traumatic stress despite drug and non-drug pain management. The Mini-Docs project of the French Red Cross has a module based on a digital device with augmented reality. Distracting the child, the use of this module on a tablet would reduce pain felt during botulinum toxin injections.

Conditions

  • Cerebral Palsy

Interventions

OTHER

use the module with augmented reality (Mini-Docs) on tablet during TB injection

Provision of a tablet with a module using augmented reality (Mini-Docs) during TB injections in addition to the commonly used drug technology

Sponsors & Collaborators

  • Fondation Apicil

    collaborator OTHER

  • Fondation Motrice

    collaborator OTHER

  • Hospices Civils de Lyon

    lead OTHER

Principal Investigators

  • Aurélie LUCET · Centre Médecine Physique et de Réadaptation pour Enfants de Bois-Larris - Croix-Rouge française

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
8 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-12-01
Primary Completion
2020-12-30
Completion
2020-12-30

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02596412 on ClinicalTrials.gov