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

Primary Purpose

Cerebral Palsy

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
use the module with augmented reality (Mini-Docs) on tablet during TB injection
Sponsored by
Hospices Civils de Lyon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Cerebral Palsy focused on measuring children, botulinum toxin, augmented reality, Pain

Eligibility Criteria

3 Years - 8 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Centre Médecine Physique et de Réadaptation pour Enfants de Bois-Larris - Croix-Rouge française
  • Centre Médico-Chirurgical de Réadaptation des Massues - Croix-Rouge française

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

augmented reality (Mini-Docs) on tablet

Control

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
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.
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

Full Information

First Posted
October 30, 2015
Last Updated
May 3, 2022
Sponsor
Hospices Civils de Lyon
Collaborators
Fondation Apicil, Fondation Motrice
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1. Study Identification

Unique Protocol Identification Number
NCT02596412
Brief Title
Augmented Reality to Reduce Pain During Botulinum Toxin Injections in Cerebral-palsied Children
Acronym
MINIDOCS
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

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
December 1, 2015 (Actual)
Primary Completion Date
December 30, 2020 (Actual)
Study Completion Date
December 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon
Collaborators
Fondation Apicil, Fondation Motrice

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy
Keywords
children, botulinum toxin, augmented reality, Pain

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
augmented reality (Mini-Docs) on tablet
Arm Type
Experimental
Arm Description
• Cerebral-palsied children using the module with augmented reality (Mini-Docs) on tablet during TB injections in addition to regular drug techniques (experimental group)
Arm Title
Control
Arm Type
No Intervention
Arm Description
Cerebral-palsied children with the usual pain care during TB injections, which combines drug techniques to distractibility techniques (control group)
Intervention Type
Other
Intervention Name(s)
use the module with augmented reality (Mini-Docs) on tablet during TB injection
Intervention Description
Provision of a tablet with a module using augmented reality (Mini-Docs) during TB injections in addition to the commonly used drug technology
Primary Outcome Measure Information:
Title
Pain during botulinum toxin (TB) injections
Description
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
Secondary Outcome Measure Information:
Title
Level of anxiety of cerebral palsied children before TB injection
Description
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
Title
Level of parental anxiety accompanying the child during care
Description
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
Title
Assessment of Mini-Docs acceptability
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aurélie LUCET
Organizational Affiliation
Centre Médecine Physique et de Réadaptation pour Enfants de Bois-Larris - Croix-Rouge française
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Médecine Physique et de Réadaptation pour Enfants de Bois-Larris - Croix-Rouge française
City
Lamorlaye
ZIP/Postal Code
60260
Country
France
Facility Name
Centre Médico-Chirurgical de Réadaptation des Massues - Croix-Rouge française
City
Lyon
ZIP/Postal Code
69322
Country
France

12. IPD Sharing Statement

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

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