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

Precocious Puberty Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04502836
• Other study ID #: RMC028220ctil
• Status: Terminated
• Phase: N/A
• Start date: December 11, 2020
• Est. completion date: April 11, 2024

Study information

• Verified date: March 2024
• Source: Rabin Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 27
• Est. completion date: April 11, 2024
• Est. primary completion date: April 11, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 7 Years to 12 Years

Eligibility

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)

Related Conditions & MeSH terms

• Precocious Puberty
• Puberty, Precocious

Intervention

Behavioral:
• Preliminary psychological intervention
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

Locations

Country	Name	City	State
Israel	Schneider Children's Medical Center of Israel	Petach Tikva

Sponsors (1)

Lead Sponsor	Collaborator
Rabin Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anxiety Questionnaire		Baseline (Visit 1), At the end of the ACTH LRH test, 2 hours
Secondary	Parents Treatment Satisfaction Questionnaire		Baseline (Visit 1), At the end of the ACTH LRH test, 2 hours