Determining the effect of counseling based on PLISSIT model on sexual quality of life of married women with multiple sclerosis referring to MS center in Isfahan in 2019
Design
A randomized controlled Clinical trial
Settings and conduct
The research environment in this study is Isfahan MS Research Center. The participants in the experimental group will enter the study after obtaining permission from the physician and participated in 4 face-to-face individual training and counseling sessions, which will last 45 to 75 minutes per session and one session per week . All the research subjects will complete the questionnaires after two weeks and two months after the intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Married women who were diagnosed with multiple sclerosis at least 6 months ago; having sex during the last 6 months; being married longer than one year; having at least one sex problem; not suffering from other acute or chronic illness other than multiple sclerosis; not dealing with severe crises such as the deaths of close relatives over the past six months; having secondary and higher education and being available within the next month.
Exclusion criteria : Severe marital conflicts (self-reported), pregnancy
Intervention groups
Experimental group: based on the PLISSIT model, face to face counseling was conducted weekly in 4 sessions and each session lasted between 45-75 minutes.
Control group: they received no intervention and only pre-test and post-test were taken from the participants in this group. In addition, all the research subjects were asked to perform the follow-up and complete the questionnaires after two weeks and two months after the intervention. In order to observe ethical issues, a control group was also provided with an educational guide on the sexual quality of life.
Main outcome variables
sexual quality of life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190614043890N1
Registration date:2020-04-19, 1399/01/31
Registration timing:retrospective
Last update:2020-04-19, 1399/01/31
Update count:0
Registration date
2020-04-19, 1399/01/31
Registrant information
Name
Zahra Kazemi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 5736 2939
Email address
kazemi2619@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-06-22, 1398/04/01
Expected recruitment end date
2019-07-21, 1398/04/30
Actual recruitment start date
2019-07-23, 1398/05/01
Actual recruitment end date
2019-08-21, 1398/05/30
Trial completion date
2019-10-15, 1398/07/23
Scientific title
Determining the effect of counseling based on PLISSIT model on sexual quality of life of married women with multiple sclerosis
Public title
The Effect of PLISSIT Model on sexual Quality of Life of Women with Multiple Sclerosis
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Married women who were diagnosed with multiple sclerosis at least 6 months ago
Having Sex during the last 6 months
Being married longer than one year
Having at least one sexual problem
Not suffering from other acute or chronic illness other than multiple sclerosis
Not dealing with severe crises such as the deaths of close relatives over the past six months
Having secondary and higher education
Being available within the next month
Exclusion criteria:
pregnancy
marital conflicts
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
62
Actual sample size reached:
62
Randomization (investigator's opinion)
Randomized
Randomization description
Selected samples were randomly assigned into two groups of control and experimental using cellphone. Sample size was calculated based on the statistical formula of 28 individuals in each group. It should be noted that 10% increase in the sample size was considered due to the probability of sample loss; therefore, 31 individuals were considered in each group.
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 Isfahan Islamic Azad University (Khorasgan)
Street address
Arghouniyah Blvd., Jey Street
City
Esfahan
Province
Isfehan
Postal code
39998-81551
Approval date
2019-07-14, 1398/04/23
Ethics committee reference number
IR.IAU.KHUISF.REC.1398.113
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 quality of life
Timepoint
14 and 60 days after training
Method of measurement
Sexual quality of life questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Experimental group: based on the PLISSIT model, face to face counseling was conducted weekly in 4 sessions and each session lasted between 45-75 minutes.
Category
Lifestyle
2
Description
Control group: they received no intervention and only pre-test and post-test were taken from the participants in this group. In addition, all the research subjects were asked to perform the follow-up and complete the questionnaires after two weeks and two months after the intervention. In order to observe ethical issues, a control group was also provided with an educational guide on the sexual quality of life..
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
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
Islamic Azad University
Full name of responsible person
Zahra kazemi
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Jey Street , Arghavani Blvd.
City
Isfahan
Province
Isfehan
Postal code
8193677695
Phone
+98 31 3500 2161
Email
Kazemi2619@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mahsa Sadat Mousavi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Jey Street, Arghavani Blvd
City
Isfahan
Province
Isfehan
Postal code
39998-81551
Phone
+98 31 3535 4001
Email
Mousavi1315@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mahsa Sadat Mousavi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Jey,Street Arghavani Blvd
City
Isfahan
Province
Isfehan
Postal code
39998-81551
Phone
+98 31 3535 4001
Email
mousavi1315@gmail.com
Web page address
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
Undecided - It is not yet known if there will be 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 variables with university permission may be shared after unidentifiable individuals.
When the data will become available and for how long
Data will be available 3 to 6 months after the results are published in journal.
To whom data/document is available
The target group is academic researchers who have access to the data that interests them.
Under which criteria data/document could be used
Analysis on demographic variables is permitted.
From where data/document is obtainable
Refer to the corresponding author's email.
mousavi1315@gmail.com
What processes are involved for a request to access data/document
It will be available in the journal 3 to 6 months after publication.
Comments
It also seems that the implementation of this model does not require advanced educational technologies and if healthcare professionals attend PLISSIT workshops, they can use the first three levels of the model for their patients, as a result, sexual problems are diagnosed and treated in the early stages.