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

Cerebral Palsy Clinical Trial

Official title: MINIDOCS : Contribution of Augmented Reality to Reduce Pain During of Botulinum Toxin Injections in Cerebral-palsied Children. A Randomized Controlled Trial

Status Completed

Clinical Trial 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.

Clinical Trial Description

Objective: To evaluate the effect of the use of a module with augmented reality (Mini-Docs) on pain during botulinum toxin injections in children with cerebral palsy aged from 3 to 8 years Method: Randomized controlled trial comparing a group of children receiving the module with augmented reality of the Mini-Docs and drug pain management (nitrous oxide and medications), with a group of children receiving the usual care of pain management that combines drug pain management (nitrous oxide and medications) and distraction techniques. The device with the augmented reality module allows the child to add virtual content to the real images of the care. The pain will be assessed for each child 10 minutes after the injections, using a self-assessment scale (the Faces Pain Scale - Revised) or a heteroevaluation scale (the Face Legs Activity Cry Consolability scale given by the nurse). The study will be conducted in two centers of physical medicine and pediatric rehabilitation of the French Red Cross (Paris and Lyon). Expected Results: - Decreasing children's pain during botulinum toxin injections - Decreasing anxiety in children and parents during injections - Increasing coping skills in children - Facilitating of the achievement of the therapeutic goal during injections ;

Related Conditions & MeSH terms

• Cerebral Palsy

• NCT number: NCT02596412
• Study type: Interventional
• Source: Hospices Civils de Lyon
• Status: Completed
• Phase: N/A
• Start date: December 1, 2015
• Completion date: December 30, 2020