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Detection of Difficulties and Improvement Compliance to Growth Hormone Treatment

NCT03005561 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2016-12-29

No results posted yet for this study

Summary

In the last 50 years the use of growth hormone (rhGH, somatropin) has become commonly to treat problems such as GH deficiency, chronic renal failure and Turner syndrome and Prader-Willi. Giving the hormone in childhood and adolescence is designed to accelerate growth to close the gap in the average population and reach a final height is normal, while minimizing risks and costs.

Noncompliance to treatment with GH is common; Other estimates are that one third to one half of patients do not comply with the provisions as require. This may result in linear growth depreciation, unnecessary diagnostic tests, unnecessary change of dosage and treatment and higher costs.

Many studies have been devoted to locating factors make it difficult to adhere to their chronic diseases in children, including conditions that require treatment with GH.

Pain is the primary cause for difficulties. In recent decades, many resources were devoted to research and development of ways of dealing with pain in all aspects.

In order to implement all of the information collected, appropriate interventions medium should be found; In this study we intend to use the method of playback. Playback define that improvisation as a theater facilitator asks the audience to share moments, feelings and stories of his daily life, and a group of actors improvise their stories in front of the stage as a kind of "play-back". Unlike hobbies such as sports or singing, the method allows not only to unload the tensions but also communication and collaboration. It is very reminiscent of psychodrama, but unlike, is not considered a therapeutic tool.

Assumption:

Intervention of two playback meetings during the year will uncover the difficulties and engage ways of dealing with pain. That will reduce the difficulties caused by GH injections and improve compliance to treatment.

Conditions

  • Growth Hormone Treatment

Interventions

BEHAVIORAL

Play Back Sessions

100 participants that will be participating in two Play Back meetings. Playback define that improvisation as a theater facilitator asks the audience to share moments, feelings and stories of his daily life, and a group of actors improvise their stories in front of the stage as a kind of "play-back". Unlike hobbies such as sports or singing, the method allows not only to unload the tensions but also communication and collaboration. It is very reminiscent of psychodrama, but unlike, is not considered a therapeutic tool.

Sponsors & Collaborators

  • Prof. Eli Hershkovitz

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
7 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-31
Primary Completion
2018-01-31
Completion
2018-03-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03005561 on ClinicalTrials.gov