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
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?
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).
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Not yet recruiting |
NCT01944488 -
LH Response to GnRH Test in Prepubescent Girls Under 6 Years
|
N/A | |
Not yet recruiting |
NCT01944475 -
Follow-up of Girls With Premature Thelarche and Precocious Puberty
|
N/A | |
Completed |
NCT00564850 -
Efficacy and Safety Study of Pamoate of Triptorelin in Children With Precocious Puberty
|
Phase 3 | |
Completed |
NCT00001181 -
Testolactone for the Treatment of Girls With LHRH Resistant Precocious Puberty
|
Phase 2 | |
Recruiting |
NCT04113070 -
Overweight and Obesity and Puberty Development Cohort Study
|
||
Recruiting |
NCT01601171 -
Genetics of Reproductive Disorders (Including Kallmann Syndrome) and Cleft Lip and/or Palate
|
||
Completed |
NCT00734279 -
Follicle-Stimulating Hormone (FSH) and the Onset of Puberty
|
Early Phase 1 | |
Recruiting |
NCT05338411 -
Effect of Exogenous Growth Hormone on Ocular Findings
|
||
Recruiting |
NCT06280807 -
Observation of Environment and Reproductive-Endocrine Effects
|
||
Completed |
NCT00004344 -
Purification of Testis-Stimulating Factor in Precocious Puberty
|
N/A | |
Completed |
NCT00001202 -
Treatment of Boys With Precocious Puberty
|
Phase 2 | |
Completed |
NCT04665713 -
Effect of Prevalence of BMI on Efficacy of Herbal Medicines in Girls' Sexual Precocity
|
||
Terminated |
NCT04502836 -
Evaluation of the Correlation Between Psychological Intervention, Including Providing Knowledge and Tools for Problems Solving, and the Anxiety Level of Female Patients Arriving to ACTH LRH Test - Pilot Study
|
N/A | |
Completed |
NCT00006174 -
Effects of Letrozole on Precocious Puberty Due to McCune Albright Syndrome
|
Phase 1 | |
Completed |
NCT02650141 -
Clinical Trial of Experienced Chinese Herbal Formulas on Different Types of Precocious Puberty
|
N/A | |
Completed |
NCT00909844 -
Effects of Triptorelin Pamoate in Children With Precocious Puberty - Follow up Study
|
Phase 3 | |
Completed |
NCT00004335 -
Study of Gonadotropin-Releasing Hormone Pulse Frequency in Sexual Maturation and in the Menstrual Cycle
|
N/A |