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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.
Full description
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.
GH therapy in all non-yielding satisfactory results, it is recommended first of all to consider noncompliance before turning to look for other causes.
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. Despite the pain seems fairly simple phenomenon, it is actually very complex. Untreated pain is manifested prominently course and immediate distress to the child and the parent, but it has other deep effects; It seems that pain not receiving treatment at early stages in children's lives adversely affects the central nervous system development. This assumption is supported by various studies.
Pain is a force in shaping behavior; 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.
Study Population:
Patients will be divided randomly into groups. The following data will be collected-
Inclusion criteria:
Exclusion criteria:
The information collected in the study will be typed in encoder. The list that links the subject and the code given to them will be kept in the ISF, that will be be accessible only to the study team. The questionnaires of the participants will be identified through a personal code given to each of the participants and will be stored in a dedicated research folder in the Endocrinology and diabetes at Soroka Medical Center.
The intervention protocol:
Visit no.1:
Visit no.2:
This visit will take place one month after the first visit. Patients that randomized to the intervention group will meet the Play Back team for the first session.
The meeting will be divided for 2 age groups: the first for 7-9 years old participants, and the second one for 10-12 years old participants.
Visit no.3:
This visit will take place 3 months after the first visit. Patients that randomized to the intervention group will meet the Play Back team for the second session.
Visit no.4:
This visit will take place 6 months after the first visit.
Univariate analyzes
Comparison of different variables between groups will be carried out according to the following rules:
Quantitative variables (such as age)that distribute normally will be compared using the t test for independent samples.
Variables that do not show normal distribution as the number of days of hospitalization between the two groups will be compared using the Mann-Whitney test. Categorical variables such as sex, will be compared using the chi-squared test.
Analysis of correlations between different variables will be using Pearson and Spearman correlations based on the distribution and type of data.
Weight and height data IGFI will be compared between subgroups according to a change in HtSDS since the start of growth hormone therapy to baseline.
A multivariate model Checking the compliance level logistic regression model was constructed multivariate where the dependent variable will be high responsiveness and low responsiveness dichotomous variable (if the patient has more than 80% response variable will receive the 1 or not (less than 80%) then receives a value of 0). Independent variables will be different risk factors which have passed the initial data analysis phase.
All statistical tests of significance level will alpha = 0.05 two-sided unless stated otherwise. All pv values shall be rounded to two decimal places.
Data analysis will be performed in Microsoft SPSS version 22.
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200 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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