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
Primary Purpose
Precocious Puberty
Status
Recruiting
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Preliminary psychological intervention
Sponsored by
About this trial
This is an interventional supportive care trial for Precocious Puberty focused on measuring ACTH LRH Test
Eligibility Criteria
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)
Sites / Locations
- Schneider Children's Medical Center of IsraelRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
preliminary psychological intervention
control group
Arm 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.
Participants in this group will not receive any psychological intervention prior to the test.
Outcomes
Primary Outcome Measures
Anxiety Questionnaire
Secondary Outcome Measures
Parents Treatment Satisfaction Questionnaire
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04502836
Brief 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
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2020 (Actual)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rabin Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Precocious Puberty
Keywords
ACTH LRH Test
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
preliminary psychological intervention
Arm Type
Experimental
Arm 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.
Arm Title
control group
Arm Type
No Intervention
Arm Description
Participants in this group will not receive any psychological intervention prior to the test.
Intervention Type
Behavioral
Intervention Name(s)
Preliminary psychological intervention
Intervention Description
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
Primary Outcome Measure Information:
Title
Anxiety Questionnaire
Time Frame
Baseline (Visit 1), At the end of the ACTH LRH test, 2 hours
Secondary Outcome Measure Information:
Title
Parents Treatment Satisfaction Questionnaire
Time Frame
Baseline (Visit 1), At the end of the ACTH LRH test, 2 hours
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Moshe Phillip, Prof
Phone
972-54-4795995
Email
moshe.phillip@phillipmd.com
First Name & Middle Initial & Last Name or Official Title & Degree
Naama Glikman, BSc
Phone
972-3-9253833
Email
naamagl@clalit.org.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Moshe Phillip, Prof
Organizational Affiliation
Schneider Children's Medical Center, Israel
Official's Role
Principal Investigator
Facility Information:
Facility Name
Schneider Children's Medical Center of Israel
City
Petach Tikva
ZIP/Postal Code
4920235
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Naama Glikman, BSc
Phone
972-3-9253833
Email
naamagl@clalit.org.il
First Name & Middle Initial & Last Name & Degree
Moshe Phillip, Prof
First Name & Middle Initial & Last Name & Degree
Alon Liberman, Dr
First Name & Middle Initial & Last Name & Degree
Rotem Diamant, Msc
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
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
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