Protocol summary

Study aim
The main objective of the project: To determine the effect of empowerment based education on the anxiety and quality of life of transgender patients under hormone therapy
Design
Clinical trials with community based and pragmatic control group, with parallel groups, without blindness, randomized
Settings and conduct
This study is based on an empowerment model based education, conducted at the Tehran Welfare Center. It is based on education based on the empowerment model (perception of threat, problem solving, learning participation, and evaluation) with the presence of clients in the form of training sessions, question and answer, and group discussion in 5 axes (definition of the nature of the disease, factors affecting the incidence of sexual illness and its severity , The ways of diagnosis and treatment, the long process of treatment, and the problems surrounding it), with emphasis on drug therapy and the impact of the treatment process and complications.
Participants/Inclusion and exclusion criteria
Entry requirements: • Having a diagnosis of transient disorder based on DSM-5 diagnostic criteria for sexual dysfunction • The absence of diagnosed psychological illness • Not having physiological disorders of the genitalia • Being at least 18 years old and up to 35 years (ie, the client is within the adult age range). • At least 6 months of taking hormonal medications
Intervention groups
In this research, the control group receives the routine training, and the intervention in test group is based on the training based on the empowerment model (threat perception, problem solving, training participation and evaluation) which is conducted by training sessions, question and answer and group discussion
Main outcome variables
Anxiety; quality of life

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20181013041321N1
Registration date: 2018-11-08, 1397/08/17
Registration timing: registered_while_recruiting

Last update: 2018-11-08, 1397/08/17
Update count: 0
Registration date
2018-11-08, 1397/08/17
Registrant information
Name
maryam asadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7790 7620
Email address
ma88mrp@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-10-27, 1397/08/05
Expected recruitment end date
2018-11-26, 1397/09/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of education based on empowerment model on anxiety and quality of life among transsexual clients undergoing hormone therapy
Public title
The effect of education based on empowerment model on anxiety and quality of life
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Having a diagnosis of transgender disorder based on DSM-5 diagnostic criteria for sexual dysfunction (diagnosis is done by psychologists and psychiatrists and recorded in the patient file) The absence of diagnosed psychological illness Not having physiological disorders of the genitalia Complete the informed consent form for participation in the study Being at least 18 years old and up to 35 years (ie, the client is within the adult age range) Pass at least 6 months of taking hormonal medications Lack of participation in similar specialized studies simultaneously Having the minimum level of fifth grade primary education or having the ability to read and write
Exclusion criteria:
Non-cooperation until the end of the plan Abandonment in training sessions more than a meeting
Age
From 18 years old to 35 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 90
Randomization (investigator's opinion)
Randomized
Randomization description
The Researcher starts sampling after referring to the welfare organization and passing the administrative procedures and observing the ethics principles and obtaining written consent. Sampling is done by continuous sampling. At first, a list of qualified applicants is provided, starting with the latest case file, and if they are eligible, they are entered in the list to complete the required sample size. After completing the allocation list of the samples in two groups, the control group and the intervention group are randomly assigned using four blocks design. Thus, the letter A is considered for the intervention group and the letter B is considered for the control group. Then, all the permutation combinations of the letters A, A and B, B, six different combinations, are written (AABB for digit 1, ABBA for digit 2 ...), and from digits 1 to 6 a digit is randomly selected (for example, if The digit 2 was chosen. The concept is that the first person in the experimental group is the next two in the control group and the fourth in the test group), and we continue this until the sample size is completed.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committee of Tehran University of Medical Sciences
Street address
Sixth Floor., Central Organization of the University., Qods St., Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1419733171
Approval date
2018-04-08, 1397/01/19
Ethics committee reference number
IR.TUMS.FNM.REC.1397.020

Health conditions studied

1

Description of health condition studied
Transsexual patients
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Quality of Life Score in SF-36 questionnaire
Timepoint
At the beginning of the study (before the intervention) and then three months after the intervention.
Method of measurement
Quality of Life Measurement: A Short Form Questionnaire 36 _Questions Of Quality Of Life

2

Description
Anxiety
Timepoint
At the beginning of the study (before the intervention) and three months after the intervention
Method of measurement
Spielberger Anxiety Inventory

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: The training is based on an empowerment model (perception of threat, problem solving, learning participation and evaluation) with the presence of clients through training sessions, question and answer, and group discussion in 5 axes (definition of the nature of the disease, factors affecting the incidence of sexual illness and severity, ways of diagnosis and Treatment, long process of treatment and problems surrounding it) with an emphasis on drug therapy and the extent of the treatment process and complications.
Category
Prevention

2

Description
Control group: Routine training of Tehran Welfare Center
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Tehran Welfare Center
Full name of responsible person
Maryam Asadi
Street address
Shahid Zolfaghari Well Being Center., Takhty street., Moalem Square., West Yaft Abad
City
Tehran
Province
Tehran
Postal code
1371789631
Phone
+98 21 6669 2332
Fax
+98 21 6663 3408
Email
info@behzisti.gov.ir
Web page address
http://tehran.behzisti.ir/Portal/Home

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Mohammad Ali Sahraeian
Street address
Research and Technology Department., 6th floor., Central University of the University., Quds St., Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 8163 3685
Fax
+98 21 8163 3698
Email
itcenter@tums.ac.ir
Web page address
http://vcr.tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Fariba Tabari
Position
science Committee
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery., Dr Mirkhani St., Tohid Square
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6692 7171
Email
ftabari@tums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Fariba Tabari
Position
science Committee
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery., Dr Mirkhani St., Tohid Square
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6692 7171
Email
ftabari@tums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Maryam Asadi
Position
Student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
NO.19, Shahid Malayeri Street, Shahid Ayat Blv, NarmaK
City
Tehran
Province
Tehran
Postal code
1646878951
Phone
+98 21 7790 7620
Fax
Email
ma88mrp@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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