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

NCT02199587 | Completed

• 1 other identifier: MeirMc069-14CTIL
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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. 1.LRH analog (decapeptyl) intramuscular injections for precocious puberty.
2. 2.Growth hormone tests.
3. 3.Changes in stress hormones: cortisol , prolactin and adrenalin during growth hormone tests in the presence of a clown.
4. 4.Does the presence of a medical clown and the mental stress affect the secretion of growth hormone?
5. 5.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?
6. 6.Are there differences in response to stress and the secretion of growth hormone in children with obesity?

Conditions

Precocious Puberty; Growth Hormone Tests

Keywords

Medical clown; Growth hormone; Precocious puberty

Outcome Measures

Primary Outcomes (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.

  At 30 min before the procedure and 30 min after the procedure

Secondary Outcomes (1)

• 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

Study Arms (2)

Endocrine test with medical clown

ACTIVE COMPARATOR

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

Endocrine test without medical clown

NO INTERVENTION

Interventions

Presence of medical clown during endocrine test BEHAVIORAL

Endocrine test with medical clown

Eligibility Criteria

• Age: 4 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• none

Sponsors & Collaborators

• Meir Medical Center: lead

Study Sites (1)

Meir Medical Center endocrine unit

Kfar Saba, Israel

Location

MeSH Terms

Conditions

Puberty, Precocious

Condition Hierarchy (Ancestors)

Gonadal Disorders; Endocrine System Diseases

Study Officials

• nitsan dror, MD

  Meir Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2014
• First Posted: July 24, 2014
• Study Start: December 17, 2014
• Primary Completion: July 16, 2018
• Study Completion: August 1, 2018
• Last Updated: October 15, 2018

Record last verified: 2018-10

Locations

IL (1)