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Precocious PubertyNCT04502836

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

A study testing Preliminary psychological intervention in people with Precocious Puberty, run by Rabin Medical Center at 1 site in Israel.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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… Read more about this study

Who is it for?
Ages 7 to 12 years, women only
Conditions the study is for
Precocious Puberty
What is being tested?
Preliminary psychological intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
27 participants
Where
1 siteIsrael
Study dates
11 Dec 2020to 11 Apr 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 7 to 12 years
  • Women only
  • No healthy volunteers
  • Child

Who may be able to join

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

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country.

Israel1 site

  • Schneider Children's Medical Center of Israel

    Petah Tikva, 4920235

Other trials in Israel

About this 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

Being tested
Preliminary psychological intervention
Keywords
ACTH LRH Test
Medical subject headings
Puberty, Precocious

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Preliminary psychological interventionBehavioural

    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

Study groups in NCT04502836
Study groupRoleWhat they receive
preliminary psychological interventionExperimentalParticipants in this group will receive a psychological intervention providing knowledge and tools for problems solving one hour prior to the ACTH LRH test.
Receives: Behavioral: Preliminary psychological intervention
control groupNo interventionParticipants in this group will not receive any psychological intervention prior to the test.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Anxiety Questionnaire

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

Secondary outcomes (1)

  1. Parents Treatment Satisfaction Questionnaire

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Aug 2020
  2. Study start11 Dec 2020
  3. Primary completion11 Apr 2024
  4. Study completion11 Apr 2024

Why it stopped: internal reasons

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
27 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04502836
Sponsor's protocol ID
RMC028220ctil
Status last verified
Mar 2024
First submitted
26 Jul 2020
Last updated
12 Apr 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Preliminary psychological intervention in people with Precocious Puberty, run by Rabin Medical Center at 1 site in Israel.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 12 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: internal reasons). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Anxiety Questionnaire (time frame: Baseline (Visit 1), At the end of the ACTH LRH test, 2 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04502836.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2024.

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