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| Name | Class |
|---|---|
| Fondation Apicil | OTHER |
| Fondation Motrice | OTHER |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| augmented reality (Mini-Docs) on tablet | Experimental | • Cerebral-palsied children using the module with augmented reality (Mini-Docs) on tablet during TB injections in addition to regular drug techniques (experimental group) |
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| Control | No Intervention | Cerebral-palsied children with the usual pain care during TB injections, which combines drug techniques to distractibility techniques (control group) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| use the module with augmented reality (Mini-Docs) on tablet during TB injection | Other | Provision of a tablet with a module using augmented reality (Mini-Docs) during TB injections in addition to the commonly used drug technology |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Assessment 10 minutes after TB injection |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Assessment up to 1h before TB injection and up to 1h after TB injection |
| Level of parental anxiety accompanying the child during care |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Aurélie LUCET | Centre Médecine Physique et de Réadaptation pour Enfants de Bois-Larris - Croix-Rouge française | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Médecine Physique et de Réadaptation pour Enfants de Bois-Larris - Croix-Rouge française | Lamorlaye | 60260 | France | |||
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| ID | Term |
|---|---|
| D002547 | Cerebral Palsy |
| D010146 | Pain |
| ID | Term |
|---|---|
| D001925 | Brain Damage, Chronic |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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It will be measured by the Stait Trait Anxiety Inventory (STAI) questionnaire before and after TB injections. |
| 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 | 7 days after TB injection |
| Centre Médico-Chirurgical de Réadaptation des Massues - Croix-Rouge française |
| Lyon |
| 69322 |
| France |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |