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

Clalit Health Services

Status: Terminated

Conditions: Precocious Puberty

Treatments: Behavioral: Preliminary psychological intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT04502836

RMC028220ctil

Details and patient eligibility

About

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

Enrollment: 27 patients

Sex: Female

Ages: 7 to 12 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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27 participants in 2 patient groups

preliminary psychological intervention

Experimental group

Description:

Participants in this group will receive a psychological intervention providing knowledge and tools for problems solving one hour prior to the ACTH LRH test.

Treatment:

Behavioral: Preliminary psychological intervention

control group

No Intervention group

Description:

Participants in this group will not receive any psychological intervention prior to the test.