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

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

Study Overview

• Status: Terminated
• Conditions: Precocious Puberty
• Intervention / Treatment: Behavioral: Preliminary psychological intervention

• Study Type: Interventional
• Enrollment (Actual): 27
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Moshe Phillip, Prof; Phone Number: 972-54-4795995; Email: moshe.phillip@phillipmd.com
• Study Contact Backup: Name: Naama Glikman, BSc; Phone Number: 972-3-9253833; Email: naamagl@clalit.org.il

Study Locations

• Israel
  • Petach Tikva, Israel, 4920235
    • Schneider Children's Medical Center of Israel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 12 years (Child)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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
No Intervention: control group; Participants in this group will not receive any psychological intervention prior to the test.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Rabin Medical Center
• Investigators: Principal Investigator: Moshe Phillip, Prof, Schneider Children's Medical Center, Israel

Study record dates

Study Major Dates

• Study Start (Actual): December 11, 2020
• Primary Completion (Actual): April 11, 2024
• Study Completion (Actual): April 11, 2024

Study Registration Dates

• First Submitted: July 26, 2020
• First Submitted That Met QC Criteria: August 4, 2020
• First Posted (Actual): August 6, 2020

Study Record Updates

• Last Update Posted (Actual): April 12, 2024
• Last Update Submitted That Met QC Criteria: April 11, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: ACTH LRH Test
• Additional Relevant MeSH Terms: Endocrine System Diseases; Gonadal Disorders; Puberty, Precocious
• Other Study ID Numbers: RMC028220ctil

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No