Clinical Trials Logo

Clinical Trial 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?


Clinical Trial 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). ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02199587
Study type Interventional
Source Meir Medical Center
Contact
Status Completed
Phase N/A
Start date December 17, 2014
Completion date August 1, 2018

See also
  Status Clinical Trial Phase
Not yet recruiting NCT01944475 - Follow-up of Girls With Premature Thelarche and Precocious Puberty N/A
Not yet recruiting NCT01944488 - LH Response to GnRH Test in Prepubescent Girls Under 6 Years 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