Evaluation of the Effect of the Presence Of Clowns on Pain and Anxiety Seen During Injections Botulinum Toxin in Child (CLOWN-TOX)

May 10, 2017 updated by: University Hospital, Brest
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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Brest, France, 29609
        • Houx

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Children receiving botulinum toxin in local pediatric day hospital

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Children between 0 and 1 year
  • Opposition formalized to the data use

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Behavioral: distraction
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, ...)
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
Behavioral: distraction
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, ...)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 hour

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of anxiety before the injections of botulinum toxins by the child and assessment by a accompanying person
Time Frame: 1 hour
evaluation of the anxiety before the botulinum toxin by the use of a VAS anxiety scale for the children and their accompanying person
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 anxiety after the botulinum toxin by the use of a VAS anxiety scale for the children and their accompanying person
1 hour
Evaluation of the course of the session of botulinum toxin by the injector doctor
Time Frame: 1 hour
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)
1 hour
Evaluation of the course of the session of botulinum toxin by the accompanying person
Time Frame: 1 hour
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)
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
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)
1 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Brest

Investigators

  • Principal Investigator: Laetitia Houx, MD, Physical Medical and Rehabilitation, CHRU Brest, France

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 10, 2015

Primary Completion (Actual)

March 20, 2017

Study Completion (Actual)

March 20, 2017

Study Registration Dates

First Submitted

August 12, 2016

First Submitted That Met QC Criteria

May 10, 2017

First Posted (Actual)

May 11, 2017

Study Record Updates

Last Update Posted (Actual)

May 11, 2017

Last Update Submitted That Met QC Criteria

May 10, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLOWN-TOX

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cerebral Palsy

Clinical Trials on distraction

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in South Korea

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe