The effect of counseling based on the Rapport Building, Exploring, Decision Making, and Implementing the Decision (REDI) model versus control group on the sexual satisfaction and quality of sexual life in women with multiple sclerosis: a randomized clinical trial
To assess the effect of counseling based on the Rapport Building, Exploring, Decision Making, and Implementing the Decision (REDI) model versus control group on the sexual satisfaction and quality of sexual life in women with multiple sclerosis
Design
This is a randomized clinical trial with a control group with parallel groups without randomization, in which eligible patients will be randomly assigned to the intervention and control groups using block randomization.
Settings and conduct
This study will be conducted at the multiple sclerosis Center in Hamadan city, involving 60 eligible women with multiple sclerosis. The patients will be randomly assigned to the intervention and control groups through the block randomization. Blinding is not feasible in this trial.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age 18 to 45
Women with multiple sclerosis
Having had active sex in the past 6 months
Exclusion criteria:
Any physical illness
Pregnancy
Intervention groups
Intervention group:
Routine multiple sclerosis treatment plus counseling sessions based on the relationship building, exploration, decision-making, and decision-making model for 60 to 90 minutes once a week for four weeks
Control group:
Only routine multiple sclerosis treatment
Main outcome variables
Primary outcome:
Sexual satisfaction score; sexual quality of life score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120215009014N552
Registration date:2025-03-09, 1403/12/19
Registration timing:prospective
Last update:2025-03-09, 1403/12/19
Update count:0
Registration date
2025-03-09, 1403/12/19
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-04-04, 1404/01/15
Expected recruitment end date
2025-06-05, 1404/03/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of counseling based on the Rapport Building, Exploring, Decision Making, and Implementing the Decision (REDI) model versus control group on the sexual satisfaction and quality of sexual life in women with multiple sclerosis: a randomized clinical trial
Public title
The effect of counseling based on the Rapport Building, Exploring, Decision Making, and Implementing the Decision (REDI) model versus control group on the sexual satisfaction and quality of sexual life in women with multiple sclerosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18 to 45
Women with multiple sclerosis
Having had active sex in the past 6 months
Exclusion criteria:
Any physical illness
Pregnancy
Age
From 18 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, random assignment of patients to the intervention and control groups will be carried out using block randomization. To achieve this, four sheets of paper will be prepared - two with the name of the intervention and two with the name of the control. These paper sheets will be pooled and placed in a container. Patients will be selected one at a time without replacement, and for each patient, a paper sheet will be randomly drawn from the container. After each draw, the paper sheets will be returned to the container, and the process will be repeated until the desired sample size is reached.
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 Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences, Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Approval date
2025-01-18, 1403/10/29
Ethics committee reference number
IR.UMSHA.REC.1403.752
Health conditions studied
1
Description of health condition studied
Multiple sclerosis
ICD-10 code
G35
ICD-10 code description
Multiple sclerosis
Primary outcomes
1
Description
Sexual satisfaction score
Timepoint
Before intervention and 4 weeks later
Method of measurement
Using the Larson Sexual Satisfaction Questionnaire
2
Description
Sexual quality of life score
Timepoint
Before intervention and 4 weeks later
Method of measurement
Using the Sexual Quality of Life Questionnaire for Women (SQOL-F)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Routine multiple sclerosis treatment plus counseling sessions based on the relationship building, exploration, decision-making, and decision-making model for 60 to 90 minutes once a week for four weeks (including explaining the importance of sex on the quality of couples' relationships, teaching the anatomy and physiology of the reproductive system, expressing sexual needs and problems, explaining the four stages of the sexual response cycle, factors affecting the decrease in sexual desire, physical and psychological differences between men and women, explaining, scrutinizing, and deciding to implement, strategies to enhance sexual desire, improving mental skills to enhance and stimulate sexual arousal, teaching skills to create variety in sexual relationships, teaching various positions in sexual relationships, answering questions, ambiguities, and possible problems of clients in implementing techniques)
Category
Treatment - Other
2
Description
Control group: Only routine multiple sclerosis treatment
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Multiple Sclerosis Center in Hamadan city
Full name of responsible person
Fatemeh Abasi
Street address
School of Nursing and Midwifery, Hamadan University of Medical Sciences, Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
ftm.99.abc@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Alireza Soltanian
Street address
Hamadan University of Medical Sciences, Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0717
Email
info.research@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Fatemeh Abasi
Position
Midwifery Student
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
School of Nursing and Midwifery, Hamadan University of Medical Sciences, Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
ftm.99.abc@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Sudabeh Aghababaii
Position
Reproductive Health Specialist
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
School of Nursing and Midwifery, Hamadan University of Medical Sciences, Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
aghababaii@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Jalal Poorolajal
Position
Professor of Epidemiology
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
School of Public Health, Hamadan University of Medical Sciences, Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Email
poorolajal@umsha.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