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Completed

NCT Number: NCT03149263

Evaluation of the Effect of the Presence Of Clowns on Pain and Anxiety Seen During Injections Botulinum Toxin in Child

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

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Key information

Conditions

Cerebral Palsy Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Muscle Hypertonia Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

2 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Houx

Brest, 29609, France

About this study

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...)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Distraction

Behavioral

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, ...)

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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)

  4. 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)

  5. 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)

Sponsors and collaborators

Lead sponsor

University Hospital, Brest

Other

Registry information

Acronym: CLOWN-TOX

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
May 11, 2017
Registry last updated
May 11, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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