A Comparative Study of the Effectiveness of a Combined Therapeutic Model with a Sexual Therapeutic-counselling Model on level of Sexual Satisfaction and Sexual Interactions of Couples with Spinal Cord Injury
Randomization method is a random assignment, and this method represents a large block for the total sample size, which means that the balance in the number of people assigned to each of the groups will be at the end of the study. For this purpose, the researcher will first complete a total sample volume Then randomly assign a set of them to the test group and assign the remainder to the control group.
Inside, a lot of balls are placed inside a lot of balls. In this research half of the balls are assigned to the intervention group and the other half to the control group. Then, the balls are randomly taken out of the container without replacement and the resulting sequence is recorded.The sample size includes twenty-eight couples, one of them with spinal cord injury. They are divided into two groups of control and test.
For the experimental group, a combined intervention (8 sessions and 2 sessions for pretest and post-test once a week), and for the routine group (control of general sexual education)
The duration of one session for couples will be shared jointly.
Is the same. After a referral session, treatment will continue. This was done in one blind spot and the participants were unaware of which section they were belonging to.
Settings and conduct
Blind rehabilitation centers
Participants/Inclusion and exclusion criteria
Age over 18 years old, at least one incomplete or complete spinal cord injury for one year or more, satisfaction
Moderate and less sexually، no history of chronic psychological and physical illness except lesion
S ,
Intervention groups
sci couple
Main outcome variables
sexual satisfaction
General information
Reason for update
Acronym
RCT
IRCT registration information
IRCT registration number:IRCT20180430039484N1
Registration date:2018-05-18, 1397/02/28
Registration timing:registered_while_recruiting
Last update:2018-05-18, 1397/02/28
Update count:0
Registration date
2018-05-18, 1397/02/28
Registrant information
Name
Zahra Salmani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6119 2210
Email address
zsalmani@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-04, 1397/01/15
Expected recruitment end date
2018-07-06, 1397/04/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A Comparative Study of the Effectiveness of a Combined Therapeutic Model with a Sexual Therapeutic-counselling Model on level of Sexual Satisfaction and Sexual Interactions of Couples with Spinal Cord Injury
Public title
effectivness of integation in coupelthrapy
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
age over 18 years old
sexual satisfaction moderate and lover
at least one year of marriage
at least cyclical agree
Exclusion criteria:
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
56
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization allocation After determining the total sample size, randomly, a set of them was allocated to the test group and the remainder to the control group
Blinding (investigator's opinion)
Single blinded
Blinding description
Participants were blinded in this study
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
medical University Tehran
Street address
gharib
City
Tehran
Province
Tehran
Postal code
1419733141
Approval date
2017-07-23, 1396/05/01
Ethics committee reference number
IR.Tums.REC.1394.1963
Health conditions studied
1
Description of health condition studied
Sexual problems of couples
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Increased sexual satisfaction
Timepoint
At the beginning of the intervention and six weeks after the intervention
Method of measurement
quesstioner
Secondary outcomes
empty
Intervention groups
1
Description
For the experimental group, the intervention therapy (8 sessions and 2 sessions for the pre-test and post-test, once a week) and for the control group, the routine treatment (general education for one session for couples jointly) will be done. If the individual Sexually only has physiological problems and only needs medical treatment, but it is kept in research if there is a problem in interactions and a sexual problem. If the couples need referrals to a psychiatrist or psychologist and an orrologist, reference is made and this is possible for everyone. After a referral session, treatment will continue. During the intervention, couples who have undergone a premature and post-traumatic disorder have not participated in the medical or test sessions or for any reason desire to leave the study will be excluded from the study. Using the standard sexual satisfaction questionnaire Marital satisfaction, sexual knowledge, intimacy, marital adjustment, and the level of sexual performance before and after the intervention, the effect of treatment on couples and control will be investigated and compared between the two groups. Data were analyzed using SPSS 16 using paired t-test, t-test, Wilcoxon, Mann-Whitney, ANCOVA, and two-way ANOVA.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Jalaei poor_ Tarasht _ Emam khomeini hospitial
Full name of responsible person
Dr.efatosadat merghati khoei
Street address
Gharib
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6119 2210
Email
zsalmani@razi.tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr.efatosadat merghati khoei
Street address
gharib
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6119 2210
Email
effat_mer@razi.tums.ac.ir
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
Tehran University of Medical Sciences
Full name of responsible person
zahra salmani
Position
resident
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
gharib
City
tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6119 2210
Email
zsalmani@razi.tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
zahra salmani
Position
resedent
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
gharib
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6119 2210
Email
zsalmani@razi.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
zahra salmani
Position
reseadent
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Gharib
City
tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6119 2210
Email
zsalmani@razi.tums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be 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