Skip to content

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

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

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04502836
Enrollment
27
Registered
2020-08-06
Start date
2020-12-11
Completion date
2024-04-11
Last updated
2024-04-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Precocious Puberty

Keywords

ACTH LRH Test

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

Interventions

BEHAVIORALPreliminary 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

Sponsors

Rabin Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
7 Years to 12 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frame
Anxiety QuestionnaireBaseline (Visit 1), At the end of the ACTH LRH test, 2 hours

Secondary

MeasureTime frame
Parents Treatment Satisfaction QuestionnaireBaseline (Visit 1), At the end of the ACTH LRH test, 2 hours

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026