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

NCT04502836 | Terminated

• 1 other identifier: RMC028220ctil
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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

Conditions

Precocious Puberty

Keywords

ACTH LRH Test

Outcome Measures

Primary Outcomes (1)

• Anxiety Questionnaire

  Baseline (Visit 1), At the end of the ACTH LRH test, 2 hours

Secondary Outcomes (1)

• Parents Treatment Satisfaction Questionnaire

  Baseline (Visit 1), At the end of the ACTH LRH test, 2 hours

Study Arms (2)

preliminary psychological intervention

EXPERIMENTAL

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

control group

NO INTERVENTION

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

Interventions

Preliminary psychological intervention BEHAVIORAL

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

preliminary psychological intervention

Eligibility Criteria

• Age: 7 Years - 12 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Girls referred to ACTH LRH or LRH test
• Age 7-12 years old
• Ability to answer questionnaire independently (hebrew language only)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Rabin Medical Center: lead

Study Sites (1)

Schneider Children's Medical Center of Israel

Petah Tikva, 4920235, Israel

Location

MeSH Terms

Conditions

Puberty, Precocious

Condition Hierarchy (Ancestors)

Gonadal Disorders; Endocrine System Diseases

Study Officials

• Moshe Phillip, Prof

  Schneider Children's Medical Center, Israel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2020
• First Posted: August 6, 2020
• Study Start: December 11, 2020
• Primary Completion: April 11, 2024
• Study Completion: April 11, 2024
• Last Updated: April 12, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)