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

NCT ID: NCT02596412

Last Updated: 2022-05-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-12-01
• Study Completion Date: 2020-12-30

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

Conditions

Cerebral Palsy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

augmented reality (Mini-Docs) on tablet

• Cerebral-palsied children using the module with augmented reality (Mini-Docs) on tablet during TB injections in addition to regular drug techniques (experimental group)

Group Type: EXPERIMENTAL

use the module with augmented reality (Mini-Docs) on tablet during TB injection

Intervention Type: OTHER

Provision of a tablet with a module using augmented reality (Mini-Docs) during TB injections in addition to the commonly used drug technology

Control

Cerebral-palsied children with the usual pain care during TB injections, which combines drug techniques to distractibility techniques (control group)

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

use the module with augmented reality (Mini-Docs) on tablet during TB injection

Provision of a tablet with a module using augmented reality (Mini-Docs) during TB injections in addition to the commonly used drug technology

Intervention Type: OTHER

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

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 8 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondation Apicil

OTHER

Sponsor Role: collaborator

Fondation Motrice

OTHER

Sponsor Role: collaborator

Hospices Civils de Lyon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Aurélie LUCET

Role: PRINCIPAL_INVESTIGATOR

Centre Médecine Physique et de Réadaptation pour Enfants de Bois-Larris - Croix-Rouge française

Locations

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

Countries

France

Other Identifiers

69HCL15-043-1

Identifier Type: -

Identifier Source: org_study_id