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
- Precocious Puberty
- Interventions
- Behavioral: Preliminary psychological intervention
- Registration Number
- NCT04502836
- Lead Sponsor
- Rabin Medical Center
- Brief Summary
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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Female
- Target Recruitment
- 27
- Girls referred to ACTH LRH or LRH test
- Age 7-12 years old
- Ability to answer questionnaire independently (hebrew language only)
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description preliminary psychological intervention Preliminary psychological intervention Participants in this group will receive a psychological intervention providing knowledge and tools for problems solving one hour prior to the ACTH LRH test.
- Primary Outcome Measures
Name Time Method Anxiety Questionnaire Baseline (Visit 1), At the end of the ACTH LRH test, 2 hours
- Secondary Outcome Measures
Name Time Method Parents Treatment Satisfaction Questionnaire Baseline (Visit 1), At the end of the ACTH LRH test, 2 hours
Trial Locations
- Locations (1)
Schneider Children's Medical Center of Israel
🇮🇱Petach Tikva, Israel