Clinical trial NCT02596412: Augmented Reality to Reduce Pain During Botulinum Toxin Injections in Cerebral-palsied Children
Official title: MINIDOCS : Contribution of Augmented Reality to Reduce Pain During of Botulinum Toxin Injections in Cerebral-palsied Children. A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Keywords: children
botulinum toxin
augmented reality
Pain
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
Collaborators: name: Fondation Apicil
name: Fondation Motrice
First posted: 2015-11-04
Enrollment: 80
Sex: ALL
Minimum age (years): 3
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed 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

Eligibility criteria: 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

Primary outcomes:
measure: Pain during botulinum toxin (TB) injections
timeFrame: Assessment 10 minutes after TB injection
Secondary outcomes:
measure: Level of anxiety of cerebral palsied children before TB injection
timeFrame: Assessment up to 1h before TB injection and up to 1h after TB injection
measure: Level of parental anxiety accompanying the child during care
timeFrame: Assessment up to 1h before TB injection and up to 1h after TB injection
measure: Assessment of Mini-Docs acceptability
timeFrame: 7 days after TB injection
Other outcomes:
Locations:
city: Lamorlaye
country: France
facility: Centre Médecine Physique et de Réadaptation pour Enfants de Bois-Larris - Croix-Rouge française
city: Lyon
country: France
facility: Centre Médico-Chirurgical de Réadaptation des Massues - Croix-Rouge française
Study officials:
affiliation: Centre Médecine Physique et de Réadaptation pour Enfants de Bois-Larris - Croix-Rouge française
name: Aurélie LUCET
role: PRINCIPAL_INVESTIGATOR
References: