Cerebral PalsyMINIDOCSNCT02596412
Augmented Reality to Reduce Pain During Botulinum Toxin Injections in Cerebral-palsied Children
A study testing use the module with augmented reality (Mini-Docs) on tablet during TB injection in people with Cerebral Palsy, run by Hospices Civils de Lyon at 2 sites in France.
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. Read more about this study
- Who is it for?
- Ages 3 to 8 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- use the module with augmented reality (Mini-Docs) on tablet during TB injection
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 2 sitesFrance
- Study dates
- 1 Dec 2015to 30 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
France2 sites
Centre Médecine Physique et de Réadaptation pour Enfants de Bois-Larris - Croix-Rouge française
Lamorlaye, 60260
Centre Médico-Chirurgical de Réadaptation des Massues - Croix-Rouge française
Lyon, 69322
About this study
Official title: MINIDOCS : Contribution of Augmented Reality to Reduce Pain During of Botulinum Toxin Injections in Cerebral-palsied Children. A Randomized Controlled Trial
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.
Read the 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
- Being tested
- use the module with augmented reality (Mini-Docs) on tablet during TB injection
- Keywords
- children, botulinum toxin, augmented reality, Pain
- Medical subject headings
- Cerebral Palsy, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
use the module with augmented reality (Mini-Docs) on tablet during TB injectionOther
Provision of a tablet with a module using augmented reality (Mini-Docs) during TB injections in addition to the commonly used drug technology
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Assessment 10 minutes after TB injection
Secondary outcomes (3)
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
Measured: Assessment up to 1h before TB injection and up to 1h after TB injection
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.
Measured: Assessment up to 1h before TB injection and up to 1h after TB injection
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
Measured: 7 days after TB injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2015 (estimated)
- Study start1 Dec 2015
- Primary completion30 Dec 2020
- Study completion30 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Collaborators
- Fondation Apicil, Fondation Motrice
- Responsible party
- Sponsor
- Investigators
- Aurélie LUCET, Principal investigator, Centre Médecine Physique et de Réadaptation pour Enfants de Bois-Larris - Croix-Rouge française
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02596412
- Sponsor's protocol ID
- 69HCL15-043-1
- Acronym
- MINIDOCS
- Status last verified
- May 2022
- First submitted
- 30 Oct 2015
- Last updated
- 6 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MINIDOCS : Contribution of Augmented Reality to Reduce Pain During of Botulinum Toxin Injections in Cerebral-palsied Children. A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02596412
- Acronym / sponsor ID
- MINIDOCS / 69HCL15-043-1
- Conditions
- Cerebral Palsy
- Keywords
- children, botulinum toxin, augmented reality, Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Collaborators
- Fondation Apicil, Fondation Motrice
- Study start
- 1 Dec 2015 (actual)
- Primary completion
- 30 Dec 2020 (actual)
- Study completion
- 30 Dec 2020 (actual)
- First posted
- 4 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| augmented reality (Mini-Docs) on tablet | Experimental | Other: use the module with augmented reality (Mini-Docs) on tablet during TB injection• Cerebral-palsied children using the module with augmented reality (Mini-Docs) on tablet during TB injections in addition to regular drug techniques (experimental group) |
| Control | No intervention | –Cerebral-palsied children with the usual pain care during TB injections, which combines drug techniques to distractibility techniques (control group) |
Who may qualify
- Ages
- 3 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| use the module with augmented reality (Mini-Docs) on tablet during TB injectionProvision of a tablet with a module using augmented reality (Mini-Docs) during TB injections in addition to the commonly used drug technology | Other | augmented reality (Mini-Docs) on tablet |
Primary outcome
Pain during botulinum toxin (TB) injections
Time frame: Assessment 10 minutes after TB injection
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.
3 secondary outcomes
Level of anxiety of cerebral palsied children before TB injection
Time frame: Assessment up to 1h before TB injection and up to 1h after TB injection
Level of parental anxiety accompanying the child during care
Time frame: Assessment up to 1h before TB injection and up to 1h after TB injection
Assessment of Mini-Docs acceptability
Time frame: 7 days after TB injection
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aurélie LUCET principal investigator
Centre Médecine Physique et de Réadaptation pour Enfants de Bois-Larris - Croix-Rouge française
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing use the module with augmented reality (Mini-Docs) on tablet during TB injection in people with Cerebral Palsy, run by Hospices Civils de Lyon at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain during botulinum toxin (TB) injections (time frame: Assessment 10 minutes after TB injection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2022.