The Effect of Medical Clown on the Pain and Anxiety Perception During LRH Analog Treatment or GH Provocation Test
Condition: Precocious Puberty; Growth Hormone Tests
MeSH terms: Puberty, Precocious
Study type: Interventional

Summary: 
      The investigators would like to examine the contribution of medical clowns in routine medical
      procedures in the endocrine clinic. This will be the first time that will objective evaluate
      the effect of medical clown on stress hormone such as adrenaline cortisol and prolactin, and
      also evaluate the effect of mental stress on growth hormone secretion in children.

      The aim of the current study is testing the pain and anxiety of the patient and the
      accompanying parent and medical staff in the presence or absence of medical clown at the
      time:

        1. LRH analog (decapeptyl) intramuscular injections for precocious puberty.

        2. Growth hormone tests.

      Secondary end point will be:

        1. Changes in stress hormones: cortisol , prolactin and adrenalin during growth hormone
           tests in the presence of a clown.

        2. Does the presence of a medical clown and the mental stress affect the secretion of
           growth hormone?

        3. Are there differences in growth hormone secretion and stress hormones between the
           various tests for growth hormone secretion (glucagon, clonidine or arginine) in the
           presence of a clown?

        4. Are there differences in response to stress and the secretion of growth hormone in
           children with obesity?
    

Detailed description: 
      80 children from the endocrine clinic who are referred for treatment with LRH analog or
      directed to growth hormone tests, will take part in the study:

      1.40 children who are referred to decapeptyl treatment will receive the injection once with a
      medical clown, and the next time with out the clown and vise verse. The pain and anxiety
      perception of the child and caregivers will be compare between the two scenarios. The
      children will be randomly assigned to begin treatment in the presence of a clown and the next
      injection without medical clown and the second group starts the injections without medical
      clown and the next shot in the presence of a clown.

      2.40 children from endocrine clinic who are referred for growth hormone tests because of
      short stature will have the test with or without medical clown in a random selection.

      Procedure

        1. Children who receive decapeptyl injections once a month. Before getting the shot will be
           offered to participate in the study. After signing the consent form and parent consent
           they randomized to get the treatment in the presence of a clown or without health.

        2. The kids and their parents who referred to growth hormone test will be offered to
           participate in the study and after signing the consent will be invited for the test.
           According to accepted protocol, the children arrived after overnight fast, an
           intravenous line is inserted and blood is taken for measurement of human growth hormone
           levels, IGF1, thyroid function test, prolactin, cortisol, and adrenaline and then a
           stimulates substance (glucagon, clonidine or arginine) is given. Afterward blood tests
           for human growth hormone and cortisol levels, are taken every 30-60 minutes for
           approximately 3-4 hours after administration of the provocative substance. During the
           test regular vital signs are monitored according to Protocol.

      In both procedures, anxiety of the child and his parent will be evaluated by questionnaires.
      State-Trait (STAI) Inventory questionnaires for the parent and STAIC questionnaires for the
      kids. In addition, the kid, his parent and the medical staff will evaluate for pain by Visual
      Analog Score (VAS).

      Inclusion criteria:

        -  Children older than 4 years.

        -  referred by the endocrine clinic to a decapeptyl treatment or growth hormone test.

      The criteria included:

      • The consent of a parent and the child to participate in a study

      Questionnaires Anxious parent questionnaire (STAI). Anxiety questionnaire (STAIC)

      Pain assessment scale:

      Pain assessment by the child, the parents and the staff (VAS).
    

Intervention name(s): Presence of medical clown during endocrine test
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Medical clown; Growth hormone; Precocious puberty