Meir Medical Center endocrine unit
Kfar Saba, Israel
NCT Number: NCT02199587
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?
Looking for future studies?
Notify Me4 year–18 year
All sexes
Interventional
Not applicable
Kfar Saba, Israel
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
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
The criteria included:
Questionnaires Anxious parent questionnaire (STAI). Anxiety questionnaire (STAIC)
Pain assessment scale:
Pain assessment by the child, the parents and the staff (VAS).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: At 30 min before the procedure and 30 min after the procedure
Time frame: At 30 min before the test and 30 min after the test
Meir Medical Center
Other
The Effect of Medical Clown on the Pain and Anxiety Perception During LRH Analog Treatment or Growth Hormone Provocation Test
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