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The effect of mobile-based APP education on sexual adjustment sexual satisfaction, marital adjustment and marital satisfaction of men with spinal cord injury

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History
# Registration date Revision Id
2 2020-01-10, 1398/10/20 117590
1 2019-07-08, 1398/04/17 96011
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  • General information

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    End of data collection
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    پایان نمونه گیری

  • Sponsors / Funding sources

    #1

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Nursing and Midwifery Care Research Center
    Full name of responsible person - Persian: مرکز تحقیقات مراقبت های پرستاری و مامایی
    Street address - English: Tehran Province, Tehran, District 6, Nosrat St
    Street address - Persian: تهران، منطقه 6، خیابان نصرت
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 1417653761
    Phone: +98 21 6692 7171
    Fax:
    Email: ncrc.iums@gmail.com
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Mohamadali Sahraeiyan
    Full name of responsible person - Persian: محمد علی صحراییان
    Street address - English: Tehran Province, Tehran, District 6, Nosrat St
    Street address - Persian: تهران، منطقه 6، خیابان نصرت
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 1417653761
    Phone: +98 21 6692 7171
    Fax:
    Email: ncrc.iums@gmail.com
    Web page address:

Protocol summary

Study aim
The effect of mobile-based educational intervention on sexual adjustment, sexual satisfaction, marital adjustment and marital satisfaction with spinal cord injury
Design
This study was a randomized controlled trial (RCT) with a parallel control group.
Settings and conduct
The application is designed to be installed on the smartphone of the intervention group and its use is explained. The intervention consists of three phases of pre-test, content training, and post-test. The app is designed to allow active training content to be immediately integrated into the intervention group after completing the pre-test form, and the group will have access to educational content for up to 8 weeks at any time and place on their mobile phone. After completing the training, the first test will be activated, and at the end of the first test, a message will be sent to the individual who will read the next 4 weeks to complete the second test. After loading and installing the application, the control group can only access the pre-test section on their mobile phone. Educational content is disabled for this group.  4 and 8 weeks after the end of the intervention, the post-test section is activated for the control group. At the end of the intervention, the control group will have access to educational content.
Participants/Inclusion and exclusion criteria
Inclusion Criteria Man with spinal cord injury Having aged over 18 years old Ability to speak Persian, Interested in participating in the study, having a mobile phone with Android system, Exclusion Criteria Chronic psychological diseases, History of drug abuse.
Intervention groups
Will receive intervention about Sexual Adjustment and Marital Adjustment Relationships via SAMAR Mobile based-App
Main outcome variables
Sexual Adjustment and Marital Adjustment Relationships

General information

Reason for update
End of data collection
Acronym
IRCT registration information
IRCT registration number: IRCT20181205041861N2
Registration date: 2019-07-08, 1398/04/17
Registration timing: prospective

Last update: 2020-01-11, 1398/10/21
Update count: 1
Registration date
2019-07-08, 1398/04/17
Registrant information
Name
Sara Kazemi
Name of organization / entity
Tarbiat Modares University
Country
Iran (Islamic Republic of)
Phone
+98 21 8882 4546
Email address
sara.kazemi@modares.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-07-10, 1398/04/19
Expected recruitment end date
2019-11-10, 1398/08/19
Actual recruitment start date
2019-07-10, 1398/04/19
Actual recruitment end date
2019-11-10, 1398/08/19
Trial completion date
2019-11-10, 1398/08/19
Scientific title
The effect of mobile-based APP education on sexual adjustment sexual satisfaction, marital adjustment and marital satisfaction of men with spinal cord injury
Public title
Mobile Phone Applications Education In SCI
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
The mere man's involvement in spinal cord injury Type of incomplete or complete traumatic spinal cord injury Duration of damage for one year or more Having aged over 18 years old Ability to speak Persian,Interested in participating in the study At least one year of life in common marriage Not attending couples' training classes before the study Having a minimum level of literacy Having a mobile phone with Android system The age difference of couples is less than or equal to 10 years Not having a history of infertility
Exclusion criteria:
People whose spinal cord injury is due to other diseases or non-traumatic causes. History of or chronic psychological disorders such as depression and anxiety History of physical problems other than spinal cord injury Excessive brain damage leading to cognitive problems History of drug abuse and history of using psychiatric drugs in the last six months
Age
From 18 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 70
Actual sample size reached: 70
Randomization (investigator's opinion)
Randomized
Randomization description
Individuals were randomly assigned to two groups of Intervention and control.
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
Ethics committee of Tehran University of Medical Sciences
Street address
Tehran, Keshavarz Blvd., Ghodss St., Central Office, Tehran University of Medical Sciences, Seventh Floor, Educational Assistant
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2016-02-22, 1394/12/03
Ethics committee reference number
IR.TUMS.REC.1394.2049

Health conditions studied

1

Description of health condition studied
Sexual adjusment
ICD-10 code
Z70.0
ICD-10 code description
Counselling related to sexual attitude

Primary outcomes

1

Description
Sexual adjustment
Timepoint
Before the intervention, 4 and 8 weeks after the intervention
Method of measurement
Hospital Anxiety and Depression Scale(SAQ)

2

Description
Sexual Satisfaction
Timepoint
Before the intervention, 4 and 8 weeks after the intervention
Method of measurement
Sexual adjustment questionnaire Larson’s

3

Description
Marital adjustment
Timepoint
Before the intervention, 4 and 8 weeks after the intervention
Method of measurement
Spinner’s Marital adjustment

4

Description
Sexual-Satisfaction
Timepoint
Before the intervention, 4 and 8 weeks after the intervention
Method of measurement
Sexual-Satisfaction scale

Secondary outcomes

1

Description
Mean score of Sexual Adjustment
Timepoint
Before the intervention, 4 and 8 weeks after the intervention
Method of measurement
Via Hospital Anxiety and Depression Scale (SAQ)

2

Description
Mean score of Sexual satisfaction
Timepoint
Before the intervention, 4 and 8 weeks after the intervention
Method of measurement
Larson’s Sexual-Satisfaction scale

3

Description
Mean score of Marital adjustment
Timepoint
Before the intervention, 4 and 8 weeks after the intervention
Method of measurement
Spinner’s’ Marital adjustment questionnaire

4

Description
Mean score of Marital satisfaction
Timepoint
Before the intervention, 4 and 8 weeks after the intervention
Method of measurement
Via Marital Satisfaction ENRICH

Intervention groups

1

Description
Intervention group: The application is designed to be installed on the smartphone of the intervention group eg ; Men with spinal cord injury and its use is explained. The intervention consists of three phases of pre-test, content training, and post-test. The app is designed to allow active training content to be immediately integrated into the intervention group after completing the pre-test form, and the group will have access to educational content for up to 8 weeks at any time and place on their mobile phone. After completing the training, the first test will be activated, and at the end of the first test, a message will be sent to the individual who will read the next 4 weeks to complete the second test.
Category
Behavior

2

Description
Control group: After loading and installing the application, the control group can only access the pre-test section on their mobile phone. Educational content is disabled for this group. 4 and 8 weeks after the end of the intervention, the post-test section is activated for the control group. At the end of the intervention, the control group will have access to educational content.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Veterans Center of the Martyr Foundation and Affaires
Full name of responsible person
Dr Raziyeh Masooumi
Street address
Taleghani Street - next to the Revolution Hotel - the central building of the Martyr Foundation and the affairs of the emperors
City
Tehran
Province
Tehran
Postal code
1234567890
Phone
+98 21 8894 7618
Email
issar@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohamadali Sahraeiyan
Street address
Tehran Province, Tehran, District 6, Nosrat St
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 6692 7171
Email
ncrc.iums@gmail.com
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
Tarbiat Modares University
Full name of responsible person
Fatemeh Zarei
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Tehran, Jalal Ale Ahmad ,Nasr.Tarbiat Modares University
City
Tehran
Province
Tehran
Postal code
1411713116
Phone
+98 21 8288 4546
Email
f.zarei@modares.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Fatemeh Zarei
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Tehran, Jalal Ale Ahmad ,Nasr.Tarbiat Modares University
City
Tehran
Province
Tehran
Postal code
1411713116
Phone
+98 21 8288 4546
Email
f.zarei@modares.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Fatemeh Zarei
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Tehran ,Jalal Ale Ahmad ,Nasr, Tarbiat Modares
City
Tehran
Province
Tehran
Postal code
1411713116
Phone
+98 21 8288 4546
Email
f.zarei@modares.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Demographic information is confidential, but information about the outcome of the participant's behavior is shareable.
When the data will become available and for how long
A week after receiving the request via email to the corresponding researcher
To whom data/document is available
Researchers in academic institutions
Under which criteria data/document could be used
Deputies of health in Medical Universities
From where data/document is obtainable
Contact with Dr.Fatemeh Zarei as the corresponding researcher via email: f.zarei@modares.ac.ir
What processes are involved for a request to access data/document
A week after receiving the request via email the corresponding researcher
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