Protocol summary

Summary
This study will be conducted to investigate the effect of group trainings and multimedia softwares on mothers’ knowledge, attitude and self- efficacy in making their 12-14 year-old sons aware of their sexual health in Mashhad. Convenience sampling will be performed in two stages in district 2 and 3 of ministry of education and training. In the first stage, from each district, two schools from male schools will be selected. In the second stage, 132 mothers will be randomly selected to participate based upon the intended criteria (access to computers, having 12-14 year-old sons, and having a nuclear family) exclusion criteria will be exiting from sexual health training sessions. In each school, 11 participants will be randomly assigned into multimedia, training and control groups. For multimedia group, intervention will be in the form of 4 CDs for 45 minutes, every week 1 CD will be available to mothers, and at the end of the fourth week a question-and-answer session will be administered for 60 minutes. For the training group, it will take four sessions (60 minutes in each) during once a week. The members of every group will be 11-10 people. Educational materials will be provided by the researcher using PowerPoint presentations, speeches, and questions and answers. The control group will be not received any training. Knowledge, attitude and self- efficacy variables will be measured at the beginning and 15 days after the intervention.

General information

Acronym
With a random start, based on the list students in the class (Close your eyes and put a finger with
IRCT registration information
IRCT registration number: IRCT2016100330116N1
Registration date: 2017-07-03, 1396/04/12
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-07-03, 1396/04/12
Registrant information
Name
Raha Rousta
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6664 6890
Email address
roustar931@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad University of Medical Sciences
Expected recruitment start date
2016-09-22, 1395/07/01
Expected recruitment end date
2016-11-21, 1395/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of group education and multimedia software on knowledge, attitude and self-efficacy mothers about of sexual health education to the boys of between 12-14 years old
Public title
Sexual health education to mothers who have 12-14 years old sons.
Purpose
Prevention
Inclusion/Exclusion criteria
Entrance criteria at the beginning of the study: being Iranian; living in Mashhad ; younger than 50; able to read and write; computer accessibility and literacy; physically healthy; living with their husbands; having a 12-14 year-old son who is studying at the first level of high school. Exclusion criteria are: addiction to Smoking and alcohol; her son has been affected by sexual problems so far; have given sexual trainings to their sons, have observed such CDs in the field of sexual health working as staff of Health System or graduates of Medical Sciences, Psychology or Counseling; now suffering from mental illness or having a history of being hospitalized in the hospital due to mental health problems or taking drugs such as imipramine, diazepam, phenobarbital, chlordiazepoxide; during the 6 months ago unfortunate incident and severe stress is not occurred; The questionnaire score for DASS 21 ( Depression scale) is over 21; The questionnaire score for the subsection of Anxiety scale is over 15; The questionnaire score for the subsection of Stress scale is over 26. Exclusion criteria during the study: More than a tablet is not observed; more than one meeting is absent; during the study, adverse events and stressful happened to them.
Age
To 45 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 108
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Quite randomly (Closing eyes and putting the finger on numbers) the participants will be selected; 11 Persons in the multimedia group; 11 Persons in the training group and 11 Persons in the control group will be randomly assigned into blocks with size of 3. All modes of possibilities will be considered to have 3 people equally into three groups of A, B and C. then, R will be employed to randomly select 11 blocks for each school. The lists for each school has been prepared and accordingly participants will be grouped.

Secondary Ids

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Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
Daneshgah Avenue, Doktora Crossroads, Ebne sina St, School of Nursing and Midwifery
City
Mashhad
Postal code
9137913199
Approval date
2016-06-11, 1395/03/22
Ethics committee reference number
IR.mums.REC.1395.164

Health conditions studied

1

Description of health condition studied
mother Knowledge, attitude and self-efficacy about sexual health education of boys 14-12 year old
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Knowledge
Timepoint
Before and two weeks after the intervention
Method of measurement
Questionnaire Self-made

2

Description
Attitude
Timepoint
Before and two weeks after the intervention
Method of measurement
Questionnaire Self-made

3

Description
self-efficacy
Timepoint
Before and two weeks after the intervention
Method of measurement
Questionnaire Self-made

Secondary outcomes

1

Description
Knowledge boys
Timepoint
Before and two weeks after the intervention
Method of measurement
questionnaire   Self-made

2

Description
Attitude boys
Timepoint
Before and two weeks after the intervention
Method of measurement
questionnaire   Self-made

Intervention groups

1

Description
The control group will be not received any training and only will be participated in the pre-test and post-test.
Category
Other

2

Description
For group Multimedia, 4 CDs will be designed and every week 1 CD-ROM will be put available to them. The first session; CD 1 (videos, animations, audio and text) regarding relationships with teens (45 min) will be handed to mothers, and explanations about how to use it will be provided. Then, three days later the participants will be called to make sure they have watched the CD, and will be asked to refer to the research center to get another CD. This procedure will be repeated for the next discs (CD2, maturity; CD3, sexual behavior; CD4, sexual health). At the end of the fourth week, the intervention group will be gather at school and question and answer session will be run for 60 minutes. Mothers will be asked to speak about to issues of CDs with his children and 15 days later the post-test will be administered.
Category
Other

3

Description
Group trainings sessions will be held once per week. Each group will be consisted of 11-10 people and four 60-minute sessions will be considered with the content of sexual health education (relationship with teens; maturity; Sexual behavior and sexual health) that will be included in CDs. Researcher will be handed all the materials to the mothers by PowerPoint presentations; lectures (45 minutes); question and answer (15 minutes). Mothers will be asked to speak about to issues of CDs with their sons and 15 days later post-tests will be held.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Hebrani School
Full name of responsible person
Mr Jedi
Street address
Shahid Saberi Boulevard, Bahar Avenue
City
Mashhad

2

Recruitment center
Name of recruitment center
khalij Fars School
Full name of responsible person
Mr Ashoori
Street address
1 Malek Abad Boulevard
City
Mashhad

3

Recruitment center
Name of recruitment center
Gadir Payam Shahed School
Full name of responsible person
Mr Sadeghi
Street address
9 Emam Reza Aveniue
City
Mashhad

4

Recruitment center
Name of recruitment center
Hastei Shohada School
Full name of responsible person
Mr Farabi
Street address
7 Danesh Gharbi Avenue
City
Mashhad

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
  Research assistance of Mashhad University of Medical Sciences
Full name of responsible person
Moohsen Tafaghodi
Street address
Research and technology assistance Mashhad University of Medical Sciences, next to Hoveyzeh Cinema, Daneshgah Avenue
City
Mashhad
Grant name
--
Grant code / Reference number
--
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
  Research assistance of Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Dr Khadijeh Mirzaii
Position
Reproductive Health Ph.D.
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Ebne Sina Street, ِDoktora Crossroads,ِ Daneshgah Avenue
City
Mashhad
Postal code
9137913199
Phone
+98 51385915113
Fax
+98 51 3859 7313
Email
k.mirzaii@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr khadijeh Mirzaii
Position
Reproductive Health Ph.D.
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Ebne Sina Street, ِDoktora Crossroads,ِ Daneshgah Avenue
City
Mashhad
Postal code
9137913199
Phone
+98 51385915113
Fax
+98 518597313
Email
k.mirzaii@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Raha Rousta
Position
Graduate student midwifery Consultation
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Ebne Sina Street, ِDoktora Crossroads,ِ Daneshgah Avenue
City
Mashhad
Postal code
9137913199
Phone
+98 51385915113
Fax
+98 51 3859 7313
Email
roustar931@mums.ac.ir; rousta.raha66@gmail.com
Web page address
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Sharing plan

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