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

Study Overview
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Brief Summary
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Over 20% of the population is reporting on white coat syndrome, manifested as anxiety symptoms and elevated BP during interaction with medical staff. It is estimated that, throughout the life span of children, approximately 15-20% will suffer from some form of a trauma relating to an interaction with health provider. The proposed study aims is to evaluate the correlation between a single preliminary psychological intervention, including providing knowledge and tools for problems solving, and the anxiety level in female patients arriving to Adrenocorticotropic Hormone (ACTH) and Lutenising Releasing Hormone (LRH) test in comparison to the anxiety in patients arriving to the same test without psychological intervention. 20 female patients arriving to ACTH LRH test for puberty stage assessment (performed as part of routine medical care) will be recruited to the study and will be randomized to one of 2 groups. Participants in the intervention group (10 patients) will be required to arrive with their parents an hour prior to the test and will receive a preliminary psychological intervention. The control group will arrive to the ACTH LRH test on the scheduled time and will not receive psychological intervention

Official Title
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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

Conditions
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Precocious Puberty

Intervention / Treatment
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* Behavioral: Preliminary psychological intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Girls referred to ACTH LRH or LRH test Age 7-12 years old Ability to answer questionnaire independently (hebrew language only) Exclusion Criteria: Mental disability Girls who were referred to the test in purpose of evaluation of the pituitary adrenal axis after prolong steroids therapy. Girls with chronic disease that required frequent hospitalization (over 4 times per year)

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: preliminary psychological intervention<br>Participants in this group will receive a psychological intervention providing knowledge and tools for problems solving one hour prior to the ACTH LRH test. | Behavioral: Preliminary psychological intervention<br>* psychological intervention including providing knowledge and tools for problems solving according to the Choice - Agenda - Resilience - Emotional support (CARE) model . After intervention session patients and their parents will be asked to complete questionnaires<br>|
| No Intervention: control group<br>Participants in this group will not receive any psychological intervention prior to the test. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anxiety Questionnaire |  | Baseline (Visit 1), At the end of the ACTH LRH test, 2 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Parents Treatment Satisfaction Questionnaire |  | Baseline (Visit 1), At the end of the ACTH LRH test, 2 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ACTH LRH Test