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.
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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
80
Provision of a tablet with a module using augmented reality (Mini-Docs) during TB injections in addition to the commonly used drug technology
Centre Médecine Physique et de Réadaptation pour Enfants de Bois-Larris - Croix-Rouge française
Lamorlaye, France
Centre Médico-Chirurgical de Réadaptation des Massues - Croix-Rouge française
Lyon, France
Pain during botulinum toxin (TB) injections
Standardized pain scores will be calculated on a scale from 0 to 10 points using validated tools adapted to the age of the child: the Faces Pain Scale - Revised (FPS-R) and the Face Legs Activity Cry Consolability (FLACC). With each scale, patient scoring ≥ 4 is defined as painful.
Time frame: Assessment 10 minutes after TB injection
Level of anxiety of cerebral palsied children before TB injection
measured by the Modified Yale Preoperative Anxiety Scale Questionnaire (m-Ypas), completed by the parents accompanying the child before and after TB injections
Time frame: Assessment up to 1h before TB injection and up to 1h after TB injection
Level of parental anxiety accompanying the child during care
It will be measured by the Stait Trait Anxiety Inventory (STAI) questionnaire before and after TB injections.
Time frame: Assessment up to 1h before TB injection and up to 1h after TB injection
Assessment of Mini-Docs acceptability
Mini-Docs acceptability will be assessed by telephone interview with the parents of the intervention group 7 days after the of TB injection
Time frame: 7 days after TB injection
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