Cerebral PalsyCLOWN-TOXNCT03149263
Evaluation of the Effect of the Presence Of Clowns on Pain and Anxiety Seen During Injections Botulinum Toxin in Child
An observational study of Cerebral Palsy and Muscle Hypertonia, run by University Hospital, Brest at 1 site in France.
Trial summary
In children requiring botulinum toxin injections, improving supervisory procedures of injection sessions to reduce pain and improve the experience of this invasive procedure is needed. Read more about this study
- Who is it for?
- Ages 2 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Cerebral Palsy, Muscle Hypertonia
- What is being tested?
- distraction
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- 10 Nov 2015to 20 Mar 2017
- Phase
- Observational
- 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 2 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Children receiving botulinum toxin in local pediatric day hospital
Who may be able to join
- Children aged 1 to 18 years
- Children with a neurogenic spasticity (cerebral palsy, spastic paraplegia, head trauma ...)
- Children with muscular pains orthopedic disorders (POPB, equino varus, ..)
- Botulinum Toxin Injection functional target, improvement in pain or amplitudes
- First injection or repeated injections of toxins
- No opposition formalized
Who cannot join
- Children between 0 and 1 year
- Opposition formalized to the data use
Trial locations and contacts
1 site in 1 country.
About this study
In children requiring botulinum toxin injections, improving supervisory procedures of injection sessions to reduce pain and improve the experience of this invasive procedure is needed. The intervention of medical clowns seems very interesting in this goal, but its effectiveness has not been proven within the botulinum toxin injections. The objective of the study is to evaluate in terms of profit the presence or absence of clowns during a session of botulinum toxins by determining their impact on pain and anxiety felt among children and their carers
Read the detailed description
In the literature, the presence of clowns allows a major reduction of pain and anxiety in children and their accompanying in various medical and hospital surgical settings. A previous study on a population of 60 children was conducted to assess the impact of the presence of clowns during the production of botulinum toxin injection in children but not confirming the benefit of their participation in carrying this medical procedure. The results of this study are opposed to current scientific data. Their impact clown assessment criteria seem however insufficient to actually support the conclusion as to the ineffectiveness of distractibility clowns in this specific medical procedure iterative injection of botulinum toxin.
The objective of the study is to evaluate the pain and anxiety before and after the botulinum toxin injection session in children and hetero-assessment of pain and anxiety by accompanying depending on the presence or not of clown. The second objectives are the evaluation of the course of the session by the injector doctor, the accompanying of the child and to evaluated the effect of distraction during the toxin of the clown or the usual distraction (music, movie...)
- Conditions
- Cerebral Palsy, Muscle Hypertonia
- Being tested
- distraction
- Keywords
- botulinum toxin, anxiety reduction, pain reduction, medical clowns, distraction
- Medical subject headings
- Cerebral Palsy, Muscle Hypertonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
distractionBehavioural
Children will all benefit toxin injections with the same protocol. Only the distraction will be different during the session: either the children will have a distraction realized by the team of clowns / or children will benefit a classic distraction (TV, music, ...)
| Study group | Role | What they receive |
|---|---|---|
| Toxin-clown | Botulinum toxin injections are carried out according to the usual injection protocol.
40 children will be included into the arm toxin with clown distraction. During injections, clowns take information with the doctor before the procedure on the child's pathology, the cognitive level, the number of injections. During injections, clowns fit and distraction can change depending on the reaction of the child to their intervention. Receives: Behavioral: distraction | |
| Toxin-usual distraction | 40 children will be included into the arm "toxin with usual distraction" The usual distraction involves discussion with the child, and its accompanying its interests, to define the use of music, songs, television, video games or other distraction during the session. If the first distraction doesn't work, it's possible to switch to another distraction during injections Receives: Behavioral: distraction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain assessment by a hetero evaluator at the time of toxin injections
Evaluation of the pain child during botulinum toxin with the FLACC (Face Legs Activity Cry Consolability) by a hetero evaluator
Measured: 1 hour
Secondary outcomes (5)
Evaluation of anxiety before the injections of botulinum toxins by the child and assessment by a accompanying person
evaluation of the anxiety before the botulinum toxin by the use of a VAS anxiety scale for the children and their accompanying person
Measured: 1 hour
Evaluation of pain and anxiety after the botulinum toxin injection session in children and the accompanying person depending on the presence or not of clowns
evaluation of the anxiety after the botulinum toxin by the use of a VAS anxiety scale for the children and their accompanying person
Measured: 1 hour
Evaluation of the course of the session of botulinum toxin by the injector doctor
Evaluation of the progress of the botulinum toxins session by the injector doctor on a scale of 0-4 (0 bad conduct and 4 very smooth conduct of the session)
Measured: 1 hour
Evaluation of the course of the session of botulinum toxin by the accompanying person
Evaluation of the progress of the botulinum toxins session by the accompanying person on a scale of 0-4 (0 bad conduct and 4 very smooth conduct of the session)
Measured: 1 hour
Evaluation of the effect of distraction during the session of botulinum toxin with the usual distraction (music, movie, ...) or the participation of the clown(s) distraction
Evaluation of the effect of distraction establishment on a scale of 0 to 4 estimated in the accompanying person (0 bad conduct and 4 very smooth conduct of the session)
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2017
- Study start10 Nov 2015
- Primary completion20 Mar 2017
- Study completion20 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laetitia Houx, MD, Principal investigator, Physical Medical and Rehabilitation, CHRU Brest, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03149263
- Sponsor's protocol ID
- CLOWN-TOX
- Acronym
- CLOWN-TOX
- Status last verified
- May 2017
- First submitted
- 12 Aug 2016
- Last updated
- 11 May 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Vagnoli L, Caprilli S, Robiglio A, Messeri A. Clown doctors as a treatment for preoperative anxiety in children: a randomized, prospective study. Pediatrics. 2005 Oct;116(4):e563-7. doi: 10.1542/peds.2005-0466.
PubMed 16199685Hansen LK, Kibaek M, Martinussen T, Kragh L, Hejl M. Effect of a clown's presence at botulinum toxin injections in children: a randomized, prospective study. J Pain Res. 2011;4:297-300. doi: 10.2147/JPR.S23199. Epub 2011 Sep 21.
PubMed 22003302Molenaers G, Schorkhuber V, Fagard K, Van Campenhout A, De Cat J, Pauwels P, Ortibus E, De Cock P, Desloovere K. Long-term use of botulinum toxin type A in children with cerebral palsy: treatment consistency. Eur J Paediatr Neurol. 2009 Sep;13(5):421-9. doi: 10.1016/j.ejpn.2008.07.008. Epub 2008 Nov 1.
PubMed 18977158Schroeder AS, Berweck S, Lee SH, Heinen F. Botulinum toxin treatment of children with cerebral palsy - a short review of different injection techniques. Neurotox Res. 2006 Apr;9(2-3):189-96. doi: 10.1007/BF03033938.
PubMed 16785117Brochard S, Blajan V, Lempereur M, Le Moine P, Peudenier S, Lefranc J, Remy-Neris O. Effectiveness of nitrous oxide and analgesic cream (lidocaine and prilocaine) for prevention of pain during intramuscular botulinum toxin injections in children. Ann Phys Rehabil Med. 2009 Dec;52(10):704-16. doi: 10.1016/j.rehab.2009.09.001. Epub 2009 Oct 6.
PubMed 19854692Bayon-Mottu M, Gambart G, Deries X, Tessiot C, Richard I, Dinomais M. Pain during injections of botulinum toxin in children: Influence of the localization technique. Ann Phys Rehabil Med. 2014 Dec;57(9-10):578-86. doi: 10.1016/j.rehab.2014.09.010. Epub 2014 Oct 8.
PubMed 25454692Houx L, Dubois A, Brochard S, Pons C. Do clowns attenuate pain and anxiety undergoing botulinum toxin injections in children? Ann Phys Rehabil Med. 2020 Oct;63(5):393-399. doi: 10.1016/j.rehab.2018.12.004. Epub 2019 Jan 29.
PubMed 30708069
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of the Presence Of Clowns on Pain and Anxiety Seen During Injections Botulinum Toxin in Child
- ClinicalTrials.gov ID
- NCT03149263
- Acronym / sponsor ID
- CLOWN-TOX / CLOWN-TOX
- Conditions
- Cerebral Palsy, Muscle Hypertonia
- Keywords
- botulinum toxin, anxiety reduction, pain reduction, medical clowns, distraction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 10 Nov 2015 (actual)
- Primary completion
- 20 Mar 2017 (actual)
- Study completion
- 20 Mar 2017 (actual)
- First posted
- 11 May 2017 (actual)
- 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.
In children requiring botulinum toxin injections, improving supervisory procedures of injection sessions to reduce pain and improve the experience of this invasive procedure is needed. The intervention of medical clowns seems very interesting in this goal, but its effectiveness has not been proven within the botulinum toxin injections. The objective of the study is to evaluate in terms of profit the presence or absence of clowns during a session of botulinum toxins by determining their impact on pain and anxiety felt among children and their carers
Detailed description
In the literature, the presence of clowns allows a major reduction of pain and anxiety in children and their accompanying in various medical and hospital surgical settings. A previous study on a population of 60 children was conducted to assess the impact of the presence of clowns during the production of botulinum toxin injection in children but not confirming the benefit of their participation in carrying this medical procedure. The results of this study are opposed to current scientific data. Their impact clown assessment criteria seem however insufficient to actually support the conclusion as to the ineffectiveness of distractibility clowns in this specific medical procedure iterative injection of botulinum toxin.
The objective of the study is to evaluate the pain and anxiety before and after the botulinum toxin injection session in children and hetero-assessment of pain and anxiety by accompanying depending on the presence or not of clown. The second objectives are the evaluation of the course of the session by the injector doctor, the accompanying of the child and to evaluated the effect of distraction during the toxin of the clown or the usual distraction (music, movie...)
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Toxin-clown | – | Behavioral: distractionBotulinum toxin injections are carried out according to the usual injection protocol. 40 children will be included into the arm toxin with clown distraction. During injections, clowns take information with the doctor before the procedure on the child's pathology, the cognitive level, the number of injections. During injections, clowns fit and distraction can change depending on the reaction of the child to their intervention. |
| Toxin-usual distraction | – | Behavioral: distraction40 children will be included into the arm "toxin with usual distraction" The usual distraction involves discussion with the child, and its accompanying its interests, to define the use of music, songs, television, video games or other distraction during the session. If the first distraction doesn't work, it's possible to switch to another distraction during injections |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Children receiving botulinum toxin in local pediatric day hospital
Key inclusion criteria (6 listed)
- Children aged 1 to 18 years
- Children with a neurogenic spasticity (cerebral palsy, spastic paraplegia, head trauma ...)
- Children with muscular pains orthopedic disorders (POPB, equino varus, ..)
- Botulinum Toxin Injection functional target, improvement in pain or amplitudes
- First injection or repeated injections of toxins
Key exclusion criteria (2 listed)
- Children between 0 and 1 year
- Opposition formalized to the data use
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 |
|---|---|---|
| distractionChildren will all benefit toxin injections with the same protocol. Only the distraction will be different during the session: either the children will have a distraction realized by the team of clowns / or children will benefit a classic distraction (TV, music, ...) | Behavioural | Toxin-clown, Toxin-usual distraction |
Primary outcome
Pain assessment by a hetero evaluator at the time of toxin injections
Time frame: 1 hour
Evaluation of the pain child during botulinum toxin with the FLACC (Face Legs Activity Cry Consolability) by a hetero evaluator
5 secondary outcomes
Evaluation of anxiety before the injections of botulinum toxins by the child and assessment by a accompanying person
Time frame: 1 hour
Evaluation of pain and anxiety after the botulinum toxin injection session in children and the accompanying person depending on the presence or not of clowns
Time frame: 1 hour
Evaluation of the course of the session of botulinum toxin by the injector doctor
Time frame: 1 hour
Evaluation of the course of the session of botulinum toxin by the accompanying person
Time frame: 1 hour
Evaluation of the effect of distraction during the session of botulinum toxin with the usual distraction (music, movie, ...) or the participation of the clown(s) distraction
Time frame: 1 hour
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 11 May 2017.
- Background: PubMed 16199685Vagnoli L, Caprilli S, Robiglio A, Messeri A. Clown doctors as a treatment for preoperative anxiety in children: a randomized, prospective study. Pediatrics. 2005 Oct;116(4):e563-7. doi: 10.1542/peds.2005-0466.
- Background: PubMed 22003302Hansen LK, Kibaek M, Martinussen T, Kragh L, Hejl M. Effect of a clown's presence at botulinum toxin injections in children: a randomized, prospective study. J Pain Res. 2011;4:297-300. doi: 10.2147/JPR.S23199. Epub 2011 Sep 21.
- Results publication: PubMed 18977158Molenaers G, Schorkhuber V, Fagard K, Van Campenhout A, De Cat J, Pauwels P, Ortibus E, De Cock P, Desloovere K. Long-term use of botulinum toxin type A in children with cerebral palsy: treatment consistency. Eur J Paediatr Neurol. 2009 Sep;13(5):421-9. doi: 10.1016/j.ejpn.2008.07.008. Epub 2008 Nov 1.
- Results publication: PubMed 16785117Schroeder AS, Berweck S, Lee SH, Heinen F. Botulinum toxin treatment of children with cerebral palsy - a short review of different injection techniques. Neurotox Res. 2006 Apr;9(2-3):189-96. doi: 10.1007/BF03033938.
- Results publication: PubMed 19854692Brochard S, Blajan V, Lempereur M, Le Moine P, Peudenier S, Lefranc J, Remy-Neris O. Effectiveness of nitrous oxide and analgesic cream (lidocaine and prilocaine) for prevention of pain during intramuscular botulinum toxin injections in children. Ann Phys Rehabil Med. 2009 Dec;52(10):704-16. doi: 10.1016/j.rehab.2009.09.001. Epub 2009 Oct 6.
- Results publication: PubMed 25454692Bayon-Mottu M, Gambart G, Deries X, Tessiot C, Richard I, Dinomais M. Pain during injections of botulinum toxin in children: Influence of the localization technique. Ann Phys Rehabil Med. 2014 Dec;57(9-10):578-86. doi: 10.1016/j.rehab.2014.09.010. Epub 2014 Oct 8.
- Derived from this study: PubMed 30708069Houx L, Dubois A, Brochard S, Pons C. Do clowns attenuate pain and anxiety undergoing botulinum toxin injections in children? Ann Phys Rehabil Med. 2020 Oct;63(5):393-399. doi: 10.1016/j.rehab.2018.12.004. Epub 2019 Jan 29.
- Individual participant dataSharing planned: No
Related trials for Cerebral Palsy
Not yet recruiting
Feasibility of a Robot-Guided Active Play Intervention for Children With Cerebral Palsy
Cerebral Palsy
Recruiting
Additional Effects on tDCS With AOT on Lower Limb Functions on Children With Diplegic CP
Diplegic Cerebral Palsy
Recruiting
Sensory Integration Therapy vs Conventional Physical Therapy in Children With Mixed Cerebral Palsy
Cerebral Palsy
Active, not recruiting
Functional Outcomes and Control Using Synchron BCI - Australia
Neurologic Disorder, Neurologic Diseases
Enrolling by invitationObservational study
Early Molecular Biomarkers for Differentiating Parkinsonian Syndromes
PARKINSON DISEASE (Disorder), Atypical Parkinsonism
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.
Laetitia Houx, MD principal investigator
Physical Medical and Rehabilitation, CHRU Brest, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebral Palsy and Muscle Hypertonia, run by University Hospital, Brest at 1 site 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 2 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 11 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 assessment by a hetero evaluator at the time of toxin injections (time frame: 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03149263, which also lists 7 linked publications.
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 11 May 2017.