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

Primary Purpose

Precocious Puberty, Growth Hormone Tests

Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Presence of medical clown during endocrine test
Sponsored by
Meir Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Precocious Puberty focused on measuring Medical clown, Growth hormone, Precocious puberty

Eligibility Criteria

4 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • none

Sites / Locations

  • Meir Medical Center endocrine unit

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Endocrine test with medical clown

Endocrine test without medical clown

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Changes in hormones: cortisol , Growth hormone, prolactin and adrenalin during growth hormone tests in the presence of a clown.

Full Information

First Posted
June 18, 2014
Last Updated
October 11, 2018
Sponsor
Meir Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02199587
Brief Title
The Effect of Medical Clown on the Pain and Anxiety Perception During LRH Analog Treatment or GH Provocation Test
Official Title
The Effect of Medical Clown on the Pain and Anxiety Perception During LRH Analog Treatment or Growth Hormone Provocation Test
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
December 17, 2014 (Actual)
Primary Completion Date
July 16, 2018 (Actual)
Study Completion Date
August 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Meir Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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: LRH analog (decapeptyl) intramuscular injections for precocious puberty. Growth hormone tests. Secondary end point will be: Changes in stress hormones: cortisol , prolactin and adrenalin during growth hormone tests in the presence of a clown. Does the presence of a medical clown and the mental stress affect the secretion of growth hormone? 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? Are there differences in response to stress and the secretion of growth hormone in children with obesity?
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 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. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Precocious Puberty, Growth Hormone Tests
Keywords
Medical clown, Growth hormone, Precocious puberty

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
58 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Endocrine test with medical clown
Arm Type
Active Comparator
Arm Description
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
Arm Title
Endocrine test without medical clown
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Presence of medical clown during endocrine test
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Children older than 4 years. referred by the endocrine clinic to a decapeptyl treatment or growth hormone test. Exclusion Criteria: none
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
nitsan dror, MD
Organizational Affiliation
Meir Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Meir Medical Center endocrine unit
City
Kfar Saba
Country
Israel

12. IPD Sharing Statement

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

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