Precocious Puberty Clinical Trial
Official title:
The Effect of Medical Clown on the Pain and Anxiety Perception During LRH Analog Treatment or Growth Hormone Provocation Test
Verified date | October 2018 |
Source | Meir Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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?
Status | Completed |
Enrollment | 58 |
Est. completion date | August 1, 2018 |
Est. primary completion date | July 16, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 4 Years to 18 Years |
Eligibility |
Inclusion Criteria: - Children older than 4 years. referred by the endocrine clinic to a decapeptyl treatment or growth hormone test. Exclusion Criteria: |
Country | Name | City | State |
---|---|---|---|
Israel | Meir Medical Center endocrine unit | Kfar Saba |
Lead Sponsor | Collaborator |
---|---|
Meir Medical Center |
Israel,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | change from base line of the anxiety of the child and his parent by State-Trait (STAI) Inventory questionnaires for the parent and STAIC questionnaires for the kids. | At 30 min before the procedure and 30 min after the procedure | ||
Secondary | Changes in hormones: cortisol , Growth hormone, prolactin and adrenalin during growth hormone tests in the presence of a clown. | At 30 min before the test and 30 min after the test |
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