The comparison of the Impact of App-Based Sexual Empowerment with Lecture on Sexual Satisfaction among spinal cord injured patients
Design
A randomized controlled clinical trial with parallel groups, single blind
Settings and conduct
this study was conducted in Birjand. The duration of the intervention was two months.
Participants/Inclusion and exclusion criteria
Inclusion criteria: injury from T8 to L2, 20 to 60 years old,being married,at least 6 months disability, reading and writing ability, smart phone and Internet access,hearing and vision health.
Exclusion Criteria :Unwillingness to continue to participate in research and divorce.
Intervention groups
Application-based group:the required content was prepared using valid sources.the content was designed as an Android app.The educational content in the app was included in the form of audiovisual. The app was provided to the app-based group for 2 months.The main topics prepared in this application were marital relations, anatomy of genital systems and sexual behaviors, unrealistic beliefs about sexual issues in sexual intimacy .
Lecture-based empowerment group:In order to implementation of intervention in the lecture-based group, a content similar to one provided for the application-based group was provided by the researcher. The content was provided using whiteboard and projector. This intervention was supervised by a South Khorasan Welfare Organization education expert. Based on the educational level, the participants in the lecture-based group was divided into three groups. Each group included 10 participants. Each session lasted about half to 1.5 hours.Intervention was given to the three groups in three separate days per week. The intervention lasted two months.Six weeks after the intervention, the questionnaires were completed
Main outcome variables
Sexual satisfaction
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190515043601N2
Registration date:2019-12-08, 1398/09/17
Registration timing:retrospective
Last update:2019-12-08, 1398/09/17
Update count:0
Registration date
2019-12-08, 1398/09/17
Registrant information
Name
Hossein Rahimi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 56 3238 1427
Email address
hosseinrahimi92@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-12-22, 1397/10/01
Expected recruitment end date
2019-01-22, 1397/11/02
Actual recruitment start date
2019-01-21, 1397/11/01
Actual recruitment end date
2019-01-22, 1397/11/02
Trial completion date
2019-06-25, 1398/04/04
Scientific title
Comparison the Impact of Application-Based Sexual Empowerment with Lecture on Sexual Satisfaction of patient with Spinal Cord injury.
Public title
Comparison the Impact of Application-Based Sexual Empowerment with Lecture on Sexual Satisfaction of patient with Spinal Cord injury.
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Spinal cord injury from T8 to L2
20 to 60 years old
being married
at least 6 months disability
reading and writing ability
access to smart phones and the Internet
visual and hearing health
Exclusion criteria:
Received systematic sex education from other institutions.
Age
From 20 years old to 60 years old
Gender
Both
Phase
2
Groups that have been masked
Data analyser
Sample size
Target sample size:
60
Actual sample size reached:
60
Randomization (investigator's opinion)
Randomized
Randomization description
After selecting 60 participants, they were divided into intervention and control groups using coin toss.
Blinding (investigator's opinion)
Single blinded
Blinding description
The data analyzer in the study was unaware of the type of intervention performed for each group
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Birjand University of Medical Sciences
Street address
ayatollah Ghafari Blvd
City
Birjand
Province
South Khorasan
Postal code
۹۷۱۷۸۵۳۵۷۷
Approval date
2018-11-20, 1397/08/29
Ethics committee reference number
IR.BUMS.REC.1397.235
Health conditions studied
1
Description of health condition studied
Sexual satisfaction
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Larson Sexual Satisfaction Questionnaire scores
Timepoint
Before intervention, 6 weeks after intervention
Method of measurement
Larson Sexual Satisfaction Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Application-based group: the required content was prepared using valid sources. the content was designed as an Android app. The educational content in the app was included in the form of audiovisual. The app was provided to the app-based group for 2 months. The main topics prepared in this application were marital relations, anatomy of genital systems and sexual behaviors, unrealistic beliefs about sexual issues in sexual intimacy .
Category
Rehabilitation
2
Description
Control group: Lecture-based empowerment group: In order to implementation of intervention in the lecture-based group, a content similar to one provided for the application-based group was provided by the researcher. The content was provided using whiteboard and projector. This intervention was supervised by a South Khorasan Welfare Organization education expert. Based on the educational level, the participants in the lecture-based group was divided into three groups. Each group included 10 participants. Each session lasted about half to 1.5 hours. Intervention was given to the three groups in three separate days per week. The intervention lasted two months. Six weeks after the intervention, the questionnaires were completed
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Welfare Organization of South Khorasan Province-Birjand
Full name of responsible person
Ali Arabnejad
Street address
End of Sanat and madan Street, Masoumieh
City
Birjand
Province
South Khorasan
Postal code
9717698751
Phone
+98 56 3240 0550
Email
Aliarabnejad@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Tuba Kazemi
Street address
Ayatollah Ghafari Blvd
City
Birjand
Province
South Khorasan
Postal code
۹۷۱۷۸۵۳۵۷۷
Phone
+98 56 3244 0260
Email
drtooba.kazemi@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Birjand 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
Birjand University of Medical Sciences
Full name of responsible person
Hossein Rahimi
Position
Instructor, Faculty Member
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Ayatollah Ghafari Blvd.
City
Birjand
Province
South Khorasan
Postal code
۹۷۱۷۸۵۳۵۷۷
Phone
+98 56 3238 1400
Email
hosseinrahimi92@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Hossein Rahimi
Position
Instructor,Faculty member
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Ayatoollah ghafari Blvd
City
Birjand
Province
South Khorasan
Postal code
۹۷۱۷۸۵۳۵۷۷
Phone
+98 56 3238 1400
Email
hosseinrahimi92@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Hossein Rahimi
Position
Instructor, Faculty Member
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Ayatollah Ghafari Blvd
City
Birjand
Province
South Khorasan
Postal code
۹۷۱۷۸۵۳۵۷۷
Phone
+98 56 3238 1400
Email
hosseinrahimi92@yahoo.com
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
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
Title and more details about the data/document
Once unrecognizable, all information is shared
When the data will become available and for how long
The access period will start in winter 1399
To whom data/document is available
All information will only be available to researchers working in academia
Under which criteria data/document could be used
After sending the request by email, the information will be sent within one month
From where data/document is obtainable
Researchers can submit their request to Hosseinrahimi92@yahoo.com. Only requests sent by email will be answered.
What processes are involved for a request to access data/document
After submitting the request by email, the applicant's identity will be requested from the relevant organization within one week.Upon verification, the information will be provided in an email