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

NCT02596412 | Completed DMC

• 1 other identifier: 69HCL15-043-1
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

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.

Conditions

Cerebral Palsy

Keywords

children; botulinum toxin; augmented reality; Pain

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• Level of anxiety of cerebral palsied children before TB injection

  Assessment up to 1h before TB injection and up to 1h after TB injection

• Level of parental anxiety accompanying the child during care

  Assessment up to 1h before TB injection and up to 1h after TB injection

• Assessment of Mini-Docs acceptability

  7 days after TB injection

Study Arms (2)

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)

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

Control

NO INTERVENTION

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

Interventions

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

augmented reality (Mini-Docs) on tablet

Eligibility Criteria

• Age: 3 Years - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead
• Fondation Apicil: collaborator
• Fondation Motrice: collaborator

Study Sites (2)

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

Lamorlaye, 60260, France

Location

Centre Médico-Chirurgical de Réadaptation des Massues - Croix-Rouge française

Lyon, 69322, France

Location

MeSH Terms

Conditions

Cerebral Palsy; Pain

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Aurélie LUCET

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2015
• First Posted: November 4, 2015
• Study Start: December 1, 2015
• Primary Completion: December 30, 2020
• Study Completion: December 30, 2020
• Last Updated: May 6, 2022

Record last verified: 2022-05

Locations

FR (2)