Augmented Reality to Reduce Pain During Botulinum Toxin Injections in Cerebral-palsied Children
CompletedNot applicableNCT02596412
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- MINIDOCS : Contribution of Augmented Reality to Reduce Pain During of Botulinum Toxin Injections in Cerebral-palsied Children. A Randomized Controlled Trial
- Conditions
- Interventions
- Other: use the module with augmented reality (Mini-Docs) on tablet during TB injection
- Sponsor
- Hospices Civils de Lyon
- Collaborators
- Fondation Apicil; Fondation Motrice
- Start date
- 2015-12-01
- Primary completion
- 2020-12-30
- Sex
- All
- Age range
- from 3 Years to 8 Years
- Results posted
- No results posted in this snapshot
- Countries
- France
- Total sites listed
- 2
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * Cerebral-palsied children, whose diagnosis of cerebral palsy was confirmed by a neurologist reported in the medical record * Aged 3 to 8 years (until the day before 9 years old) * With a functional level of Gross Motor Function Classification System (GMFCS) I, II, III or IV * Treated by TB injection (child with or without a history of TB injections) * With a sufficient level oral expression to respond to questionnaires and to interact with the nurse for the use of augmented reality device * Obtaining written parental consent and oral approval by the child Exclusion Criteria: * Impossibility to assess pain during the session by the FLACC scale or FPS-R scale * Visual disturbances excluding to use of the augmented reality device * Severe cognitive impairment making it possible to answer questionnaires * Child of functional level child GMFCS V * Child with a specific request for distraction (eg if the child demands to watch a cartoon). This in order not to interfere with the coping strategies used by the child. * Refusal on the part of the parents to sign consent, and refusal on the part of child to use the tablet * Child not benefiting from social security coverage
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT02596412