Determining the effect of counseling based on PLISSIT model on family performance and sexual quality of life in patients with multiple sclerosis
Design
This study is a clinical trial with two groups (intervention and control), double blinded (the data analyst and participants) and randomized, with 30 patients in each group. In the intervention group, 4 counseling sessions
Based on the PLISSIT model over 4 weeks
And a 90-minute session per week is done individually; While control group patients will receive routine procedures. Family performance score and
The Sexual Quality of Life score will be measured before and after the intervention.
Settings and conduct
This double blinded study (the data analyst and participants), will be done in the Kerman Medical Center of the Special Diseases.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Married women who complain of sexual dysfunction
Ability to communicate in Persian language
Diagnosis of Multiple Sclerosis according to neurologist confirmation
Continuous attendance at counseling sessions
Exit criteria: Failure to attend one of the meetings and the occurrence of a stressful incident
Cases of recurrence of symptoms during the intervention so that it can be effective in our intervention
Pregnancy, lactation or Pregnancy desire
Suffering from other mental and physical illnesses
Addiction to alcohol and drugs, according to the patient
History of genital and breast surgery
Intervention groups
In the intervention group, 4 counseling sessions
Based on the PLISSIT model over 4 weeks
And a 90-minute session per week is done individually; While control group patients will receive routine procedures. Family performance score and
The Sexual Quality of Life score will be measured before and after the intervention.
Main outcome variables
family performance and sexual quality
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20151107024919N9
Registration date:2020-04-28, 1399/02/09
Registration timing:retrospective
Last update:2020-04-28, 1399/02/09
Update count:0
Registration date
2020-04-28, 1399/02/09
Registrant information
Name
Batoul Tirgari
Name of organization / entity
Kerman Medical University of Sciences
Country
Iran (Islamic Republic of)
Phone
+98 34 3132 5207
Email address
b_tirgari@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-12-22, 1398/10/01
Expected recruitment end date
2020-02-20, 1398/12/01
Actual recruitment start date
2019-12-31, 1398/10/10
Actual recruitment end date
2020-03-08, 1398/12/18
Trial completion date
2020-04-08, 1399/01/20
Scientific title
The effectiveness of consultation based on PLISSIT model on Family Function and Sexual Quality of Life in patients with multiple sclerosis
Public title
The effectiveness of Sexual counseling on Family Function and Sexual Quality of Life in patients with MS
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Married women who complain of sexual dysfunction
Ability to communicate in Persian language
Diagnosis of Multiple Sclerosis according to neurologist confirmation
Continuous attendance at counseling sessions
Exclusion criteria:
Failure to attend one of the meetings and the occurrence of a stressful incident
Cases of recurrence of symptoms during the intervention so that it can be effective in our intervention
Pregnancy, lactation or Pregnancy desire
Suffering from other mental and physical illnesses
Addiction to alcohol and drugs, according to the patient
History of genital and breast surgery
Age
From 18 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
60
Actual sample size reached:
60
Randomization (investigator's opinion)
Randomized
Randomization description
In order to allocate the subjects to the intervention and control groups, a randomized classification method is used, so that people in terms of Family performance score, Quality of sex life score, drug use by patients, type of disease, duration of illness, etc. are divided into groups. Subsequently, through the use of a simple method and using Excel software from each group, half of the subjects are placed in the intervention group and the other half are in the control group.
Blinding (investigator's opinion)
Double blinded
Blinding description
The participants and data analyst do not know which data is related to the intervention group and which data is related to the control group.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Kerman University of Medical Sciences
Street address
Medical Center of the Special Diseases, No. 78 Alley, Shahid Rajaee Street,
City
kerman
Province
Kerman
Postal code
7619875994
Approval date
2019-10-21, 1398/07/29
Ethics committee reference number
IR.KMU.REC.1398.303
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
Family Function score
Timepoint
The Family Function score will be measured before and after the intervention at the end of the fourth week.
Method of measurement
Family functioning scale
2
Description
Sexual Quality of Life score
Timepoint
Sexual Quality of Life score will be measured before and after the intervention at the end of the fourth week.
Method of measurement
Sexual Quality of Life–Female Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:They receive 4 counseling sessions over 4 weeks, one 90-minute session per week, individually and face-to-face.The PLISSIT model will be used for consultation.The content of the counseling sessions includes the following:Session 1: Opportunity to Patient (P): At this stage, the therapist allows the patient to maintain the correct sexual traditions in order to remain sexually active, and at the same time encourages the patient to discuss the problems that It damages her sexual function. Session 2: Limited Information (LI): The patient is given information about the anatomical and physiological aspects of sexual function and information about MS and its side effects on sexual function.Session 3: Specific Suggestions (SS): At this stage, specific suggestions for the patient's specific concerns, counseling on the choice of alternative sex positions, and strategies to improve sexual satisfaction are provided.Session 4: Intensive Care (IT): In a few cases where people have underlying causes in their sexual problems that cannot be resolved in the first 3 steps, intensive treatment will be needed. By identifying these situations, the researcher will refer the patient to a specialist.
Category
Other
2
Description
Control group: Patients in the control group received routine methods such as exercise, relaxation techniques, etc.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Medical Center of the Special Diseases
Full name of responsible person
Batool Tirgari
Street address
Medical Center of the Special Diseases, No. 78 Alley, Shahid Rajaee Street,
City
Kerman
Province
Kerman
Postal code
7619875994
Phone
+98 34 3271 2001
Fax
+98 34 3271 2127
Email
b_tirgari@kmu.ac.ir
Web page address
http://kmu.ac.ir/fa/snm
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Abbas Pardakhti
Street address
No 2, Research and Technology Dept., Ibnsina Ave., Kerman
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3121 7213
Fax
Email
abpardakhty@kmu.ac.ir
Web page address
http://kmu.ac.ir/fa/vcrt
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman 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
Kerman University of Medical Sciences
Full name of responsible person
Batool Tirgari
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Kerman University of Medical Sciences, Medical University Campus, Haft- Bagh- Alavi Highway, Kerman
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5207
Fax
+98 34 3132 5184
Email
b_tirgari@kmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Batool Tirgari
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Kerman University of Medical Sciences, Medical University Campus, Haft-Bagh-Alavi Highway, Kerman
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5207
Fax
+98 34 3132 5184
Email
b_tirgari@kmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Batool Tirgari
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Kerman University of Medical Sciences, Medical University Campus, Haft-Bagh-Alavi Highway, Kerman
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5207
Fax
+98 34 3132 5184
Email
b_tirgari@kmu.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