Protocol summary
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Study aim
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The effect of mobile-based educational intervention on sexual adjustment, sexual satisfaction, marital adjustment and marital satisfaction with spinal cord injury
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Design
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This study was a randomized controlled trial (RCT) with a
parallel control group.
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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.
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Intervention groups
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Will receive intervention about Sexual Adjustment and Marital Adjustment Relationships via SAMAR Mobile based-App
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Main outcome variables
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Sexual Adjustment and Marital Adjustment Relationships
General information
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Reason for update
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End of data collection
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Acronym
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IRCT registration information
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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
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Registration date
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2019-07-08, 1398/04/17
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2019-07-10, 1398/04/19
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Expected recruitment end date
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2019-11-10, 1398/08/19
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Actual recruitment start date
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2019-07-10, 1398/04/19
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Actual recruitment end date
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2019-11-10, 1398/08/19
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Trial completion date
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2019-11-10, 1398/08/19
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Scientific title
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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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Public title
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Mobile Phone Applications Education In SCI
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Purpose
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Education/Guidance
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Inclusion/Exclusion criteria
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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
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Age
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From 18 years old
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Gender
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Male
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Phase
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N/A
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Groups that have been masked
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No information
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Sample size
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Target sample size:
70
Actual sample size reached:
70
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Individuals were randomly assigned to two groups of Intervention and control.
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2016-02-22, 1394/12/03
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Ethics committee reference number
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IR.TUMS.REC.1394.2049
Health conditions studied
1
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Description of health condition studied
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Sexual adjusment
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ICD-10 code
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Z70.0
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ICD-10 code description
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Counselling related to sexual attitude
Primary outcomes
1
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Description
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Sexual adjustment
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Timepoint
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Before the intervention, 4 and 8 weeks after the intervention
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Method of measurement
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Hospital Anxiety and Depression Scale(SAQ)
2
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Description
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Sexual Satisfaction
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Timepoint
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Before the intervention, 4 and 8 weeks after the intervention
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Method of measurement
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Sexual adjustment questionnaire Larson’s
3
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Description
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Marital adjustment
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Timepoint
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Before the intervention, 4 and 8 weeks after the intervention
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Method of measurement
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Spinner’s Marital adjustment
4
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Description
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Sexual-Satisfaction
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Timepoint
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Before the intervention, 4 and 8 weeks after the intervention
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Method of measurement
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Sexual-Satisfaction scale
Secondary outcomes
1
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Description
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Mean score of Sexual Adjustment
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Timepoint
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Before the intervention, 4 and 8 weeks after the intervention
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Method of measurement
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Via Hospital Anxiety and Depression Scale (SAQ)
2
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Description
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Mean score of Sexual satisfaction
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Timepoint
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Before the intervention, 4 and 8 weeks after the intervention
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Method of measurement
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Larson’s Sexual-Satisfaction scale
3
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Description
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Mean score of Marital adjustment
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Timepoint
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Before the intervention, 4 and 8 weeks after the intervention
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Method of measurement
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Spinner’s’ Marital adjustment questionnaire
4
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Description
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Mean score of Marital satisfaction
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Timepoint
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Before the intervention, 4 and 8 weeks after the intervention
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Method of measurement
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Via Marital Satisfaction ENRICH
Intervention groups
1
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Description
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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.
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Category
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Behavior
2
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Description
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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.
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Category
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Behavior
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Tehran University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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Demographic information is confidential, but information
about the outcome of the participant's behavior is shareable.
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When the data will become available and for how long
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A week after receiving the request via email to the corresponding researcher
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To whom data/document is available
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Researchers in academic institutions
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Under which criteria data/document could be used
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Deputies of health in Medical Universities
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From where data/document is obtainable
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Contact with Dr.Fatemeh Zarei as the corresponding researcher via email: f.zarei@modares.ac.ir
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What processes are involved for a request to access data/document
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A week after receiving the request via email the corresponding researcher
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Comments
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