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

Cerebral Palsy Clinical Trial

— MINIDOCS  

Official title:

MINIDOCS : Contribution of Augmented Reality to Reduce Pain During of Botulinum Toxin Injections in Cerebral-palsied Children. A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02596412
• Other study ID #: 69HCL15-043-1
• Status: Completed
• Phase: N/A
• Start date: December 1, 2015
• Est. completion date: December 30, 2020

Study information

• Verified date: May 2022
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: December 30, 2020
• Est. primary completion date: December 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 8 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Palsy

Intervention

Other:
• 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

Locations

Country	Name	City	State
France	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

Sponsors (3)

Lead Sponsor	Collaborator
Hospices Civils de Lyon	Fondation Apicil, Fondation Motrice

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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 up to 1h before TB injection and up to 1h after TB injection
Secondary	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