The effect of Ex-PLISSIT model based sexual counseling on the intimacy and sexuality of married women with multiple sclerosis: a randomized controlled trial
The aim of this study is to determine the effect of Ex-PLISSIT model based sexual counseling on the intimacy and sexuality of married women with multiple sclerosis. The participants are 42 married women aged 18 to 45 years with multiple sclerosis in Tabriz. They will randomly be allocated in two groups. In the intervention group, consultation will be held in one session for 90-60 minutes or more sessions if needed (i.e. intensive therapy) in accordance with the EX-PLISSIT model components. Control group will just receive routine care. The primary outcome are intimacy and sexuality before and two months after intervention measured by MSISQ-19.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017051833834N2
Registration date:2017-06-18, 1396/03/28
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-06-18, 1396/03/28
Registrant information
Name
Roghaiyeh Nourizadeh
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 3479 6770
Email address
nourizadehr@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabrize University of Medical Sciences
Expected recruitment start date
2017-05-27, 1396/03/06
Expected recruitment end date
2017-10-22, 1396/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Ex-PLISSIT model based sexual counseling on the intimacy and sexuality of married women with multiple sclerosis: a randomized controlled trial
Public title
The effect of Ex-PLISSIT model based sexual counseling on the intimacy and sexuality of married women with multiple sclerosis: a randomized controlled trial
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: The minimum literacy of secondary school; At least 6 months after diagnosis of MS; sexually active married women; women aged 18-45 years; Ability of listening and speaking; At least one year after marriage; Having a contact number to follow-up; Without major disability (EDSS <7); Exclusion criteria: Pregnant and lactating women؛ Hospitalization due to MS disease progression or relapse within the last month; Presence of other diseases affecting sexual function; Drug addiction and smoking; Using drugs affect sexual function; Being treatment due to sexual dysfunction; Women with depression score ≥16 in short form of the Beck Depression Inventory
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:
42
Randomization (investigator's opinion)
Randomized
Randomization description
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
Tabriz University of Medical Sciences (Nursing and Midwifery)
Street address
Azady Street / Golgasht (South Shariati)
City
Tabriz
Postal code
Approval date
2017-05-08, 1396/02/18
Ethics committee reference number
IR.TBZMED.REC.1396.115
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
Intimacy and sexuality
Timepoint
Before and two months after intervention
Method of measurement
MSISQ-19
Secondary outcomes
1
Description
Quality of sexual life
Timepoint
Before and two months after intervention
Method of measurement
SQOL-F
Intervention groups
1
Description
In the intervention group (21 women), consultation will be held in one session for 90-60 minutes or more sessions if needed (i.e. intensive therapy) in accordance with the model components.
Category
Treatment - Other
2
Description
In the usual care control group will be
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
MS Society of East Azerbaijan
Full name of responsible person
Roya Azari Barzandig
Street address
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mohammad Reza Rashidi
Street address
Vice President of Research, Tabriz University of Medical Sciences
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Roya Azari Barzandig
Position
MSc of Counseling in Midwifery
Other areas of specialty/work
Street address
Azadi Street / Golgasht (South Shariati Ave/School of Nursing and Midwifery
City
Tabriz
Postal code
Phone
+98 41 3479 6770
Fax
Email
Azari2011e@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences (Faculty of Nursing and Midwifery)
Full name of responsible person
Dr. Roghaiyeh Nourizadeh
Position
PhD in reproductive health
Other areas of specialty/work
Street address
Azadi Street / Golgasht (South Shariati Ave/School of Nursing and Midwifery
City
Tabriz
Postal code
Phone
+98 41 3479 6770
Fax
Email
rnourizadeh@gmail.com /nourizadehr@tbzmed.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Roya Azari Barzandig
Position
MSc of Counseling in Midwifery
Other areas of specialty/work
Street address
Azadi Street / Golgasht (South Shariati Ave/School of Nursing and Midwifery
City
Tabriz
Postal code
Phone
+98 41 3479 6770
Fax
Email
Azari2011e@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)