Protocol summary

Summary
Title: The effect of the computer- based training package on quality of life and symptom severity in andropausal men Primary objectives of the study: To determine the effect of the computer- based training package on quality of life (QoL) and symptom severity in andropausal men Secondary objectives of the study: 1. To determine the prevalence of andropause symptoms in 40-60 year-old employees; 2. To compare the severity of andropause symptoms in male employees aged 40-60 before and after the intervention; 3. To compare QoL in male employees aged 40-60 before and after the intervention. A quasi-experimental study will be conducted to determine the impact of the computer-based training package on QoL and severity of symptoms in andropausal men prior to and 8 weeks after the training in both intervention and control groups. The study population will consist of all 40-60 year-old male employees at Tehran University of Medical Sciences’ Faculties. Inclusion criteria: Proficiency in Persian, being emotionally and physically able to answer questions, being married, having at least high school education, having access to computers, being able to work with the computer to the extent that the training package be used, lack of chronic diseases & mental disorders, lack of disability. Exclusion criteria: Unwillingness to participate in the study, incomplete responses to the questionnaire, being affected with a chronic disease and mental disorder during the study. The required sample size for each group was estimated at n=40. To randomly select the faculties of Tehran University of Medical Sciences the names of all the faculties will be written on separate sheets. Then, an intercollegiate draw will take place. After obtaining written consents from all the participants, they will be handed the following: the AMS (Aging Male Symptoms) questionnaire that screens andropause symptoms and assesses their severity; and the SF36 (Short Form 36) questionnaire that determines QoL. After having completed the questionnaire, those with andropause symptoms and those who possess the inclusion criteria will be included in the final study. Computer-based training will be held for the men in the intervention group in the form of 4 sessions over a period of 4 weeks. Two months after the intervention, QoL and symptom severity will be measured in the intervention group. Moreover, both the intervention and control groups will be asked to complete the questionnaires again, two months after the initial test. Finally, the results of the two groups before and after the intervention will be compared with each other. In the end, the control group’s participants will too be provided with the training package.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201407166777N3
Registration date: 2014-11-03, 1393/08/12
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2014-11-03, 1393/08/12
Registrant information
Name
Minoo Pakgohar
Name of organization / entity
School of Nursing & Midwifery, Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6105 4216
Email address
mpakgohar@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences, Vice chancellor for research,
Expected recruitment start date
2014-08-23, 1393/06/01
Expected recruitment end date
2014-10-23, 1393/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of the computer- based training package on quality of life and symptom severity in andropausal men
Public title
The effect of the computer- based training package on quality of life and symptom severity in andropausal men
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Proficiency in Persian, being emotionally and physically able to answer questions, being married, having at least high school education, having access to computers, being able to work with the computer to the extent that the training package be used, lack of chronic diseases & mental disorders, lack of disability. Exclusion criteria: Unwillingness to participate in the study, incomplete responses to the questionnaire, being affected with a chronic disease and mental disorder during the study.
Age
From 53 years old to 33 years old
Gender
Male
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
To randomly select the faculties of Tehran University of Medical Sciences the names of all the faculties will be written on separate sheets. Then, an intercollegiate draw will take place.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Bolvarkshavrz, Quds Street
City
Tehran
Postal code
Approval date
2014-07-08, 1393/04/17
Ethics committee reference number
93/د/130/856

Health conditions studied

1

Description of health condition studied
andropause
ICD-10 code
-----
ICD-10 code description
-----

Primary outcomes

1

Description
Quality Of Life
Timepoint
Before the experiment, two months after the intervention
Method of measurement
Questionnaire Sf36

2

Description
Symptoms Severity
Timepoint
Before the experiment, two months after the intervention
Method of measurement
AMS Questionnaire

Secondary outcomes

1

Description
-----
Timepoint
------
Method of measurement
------

Intervention groups

1

Description
Intervention group: Computer-based training will be held for the men in the intervention group in the form of 4 sessions over a period of 4 weeks. Two months after the intervention, QoL and symptom severity will be measured in the intervention group. Moreover, both the intervention and control groups will be asked to complete the questionnaires again, two months after the initial test. Finally, the results of the two groups before and after the intervention will be compared with each other.
Category
Lifestyle

2

Description
Control group: Computer-based training won't be held for the men in the control group. In the control group will be asked to complete the questionnaires again, two months after the initial test. Finally, the results of the two groups before and after the intervention will be compared with each other. In the end, the control group’s participants will too be provided with the training package.
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
School of Health, Tehran University of Medical Sciences
Full name of responsible person
Dr Ali Akbari Sari
Street address
Poorsina Street,Tehran
City
Tehran

2

Recruitment center
Name of recruitment center
Faculty of Pharmacy, Tehran University of Medical Sciences
Full name of responsible person
Dr Mohamad Sharif Zade
Street address
The old building of the Faculty of Pharmacy, Tehran
City
Tehran

3

Recruitment center
Name of recruitment center
School of Medicine, Tehran University of Medical Sciences
Full name of responsible person
Dr Amirhosein Emami
Street address
Poorsina Street, Ghods Street,Tehran
City
Tehran

4

Recruitment center
Name of recruitment center
Faculty of Dentistry, Tehran University of Medical Sciences
Full name of responsible person
Dr Mohamad Bayat
Street address
Kargar Shomali Street, Tehran
City
Tehran

5

Recruitment center
Name of recruitment center
Rehabilitation Faculty, Tehran University of Medical Sciences
Full name of responsible person
Dr Mohamad Akbari
Street address
Enghelab Street, Tehran
City
Tehran

6

Recruitment center
Name of recruitment center
School of Allied Medical Sciences, Tehran University of Medical Sciences
Full name of responsible person
Dr Reza Safdari
Street address
Ghods Street, Enghelab Street,Tehran
City
Tehran

7

Recruitment center
Name of recruitment center
School of Nursing and Midwifery, Tehran University of Medical Sciences
Full name of responsible person
Dr Mohamad Ali Cheraghi
Street address
Nosrat Street, Tohid Square, Tehran
City
Tehran

8

Recruitment center
Name of recruitment center
Department of Traditional Medicine, Tehran University of Medical Sciences
Full name of responsible person
Dr Mohamadreza Shams Ardakani
Street address
Poorsina Street,Tehran
City
Tehran

9

Recruitment center
Name of recruitment center
Tehran medical technologies, Tehran University of Medical Sciences
Full name of responsible person
Dr Alireza Ahmadian
Street address
Italia Street,Ghods Street, Keshavarz Bolvar, Tehran
City
Tehran

10

Recruitment center
Name of recruitment center
Faculty of Nutrition and Diet, Tehran University of Medical Sciences
Full name of responsible person
Dr Fereydoon Siasi
Street address
Naderi Street
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for research of Tehran University of Medical Sciences
Full name of responsible person
Dr masoud younesian
Street address
Bolvar keshavarz, Ghods street
City
Tehran
Grant name
----
Grant code / Reference number
---
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research of Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Tehran univesity of medical science
Full name of responsible person
Elahe afsharnia
Position
Student of Master of Science in Midwifery
Other areas of specialty/work
Street address
Valiasr Square, Damascus street, Tehran
City
Tehran
Postal code
Phone
+98 910 576 2775
Fax
Email
Elahe.afsharnia@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Minoo pak gohar
Position
Phd of Geronatology
Other areas of specialty/work
Street address
Tohid square, Nosrat street
City
Tehran
Postal code
Phone
+98 912 140 2531
Fax
Email
Mpakgohar@razi.tums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Elahe afsharnia
Position
Student of Master of Science in Midwifery
Other areas of specialty/work
Street address
Damascud street, Tehran
City
Tehran
Postal code
Phone
00
Fax
Email
Elahe.afsharnia@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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