Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Effect of Medical Clown on the Pain and Anxiety Perception During LRH Analog Treatment or GH Provocation Test

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02199587
Recruitment Status : Completed
First Posted : July 24, 2014
Last Update Posted : October 15, 2018
Sponsor:
Information provided by (Responsible Party):
Meir Medical Center

Brief 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?

Condition or disease Intervention/treatment Phase
Precocious Puberty Growth Hormone Tests Behavioral: Presence of medical clown during endocrine test Not Applicable

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).


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 58 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: The Effect of Medical Clown on the Pain and Anxiety Perception During LRH Analog Treatment or Growth Hormone Provocation Test
Actual Study Start Date : December 17, 2014
Actual Primary Completion Date : July 16, 2018
Actual Study Completion Date : August 1, 2018


Arm Intervention/treatment
Active Comparator: Endocrine test with medical clown
children who are referred to endocrine test will have the procedure with a medical clown, or without. The pain and anxiety perception of the child and caregivers will be compare between the two scenarios
Behavioral: Presence of medical clown during endocrine test
No Intervention: Endocrine test without medical clown



Primary Outcome Measures :
  1. 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. [ Time Frame: At 30 min before the procedure and 30 min after the procedure ]

Secondary Outcome Measures :
  1. Changes in hormones: cortisol , Growth hormone, prolactin and adrenalin during growth hormone tests in the presence of a clown. [ Time Frame: At 30 min before the test and 30 min after the test ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   4 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Children older than 4 years. referred by the endocrine clinic to a decapeptyl treatment or growth hormone test.

Exclusion Criteria:

  • none

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02199587


Locations
Layout table for location information
Israel
Meir Medical Center endocrine unit
Kfar Saba, Israel
Sponsors and Collaborators
Meir Medical Center
Investigators
Layout table for investigator information
Principal Investigator: nitsan dror, MD Meir Medical Center

Layout table for additonal information
Responsible Party: Meir Medical Center
ClinicalTrials.gov Identifier: NCT02199587     History of Changes
Other Study ID Numbers: MeirMc069-14CTIL
First Posted: July 24, 2014    Key Record Dates
Last Update Posted: October 15, 2018
Last Verified: October 2018
Keywords provided by Meir Medical Center:
Medical clown
Growth hormone
Precocious puberty
Additional relevant MeSH terms:
Layout table for MeSH terms
Puberty, Precocious
Gonadal Disorders
Endocrine System Diseases
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs