Comparison of impact of PLISSIT (Permission, Limited Information, Specific Suggestion, Intensive Therapy) model and personal counseling on sexual function in married women suffer from multiple sclerosis with sexual dysfunction
This is a randomized clinical trial study. It will be conducted in Iranian Community of Multiple Sclerosis Patient Support. One-hundred and twenty women who are married and have sexual problems randomly will be assigned to control, experimental group-A and experimental group-B. The experimental group-A will receive consultation based on PLISSIT (Permission, Limited Information, Specific Suggestion, Intensive Therapy model by a trained midwife, the experimental groups-B will receive personal consultation and the control group will receive routine sexual consultation. Demographic and obstetric information will be gathered through standard questionnaire. FSFI(Female Sexual Function Index) questionnaire will be used for assessing sexual function. Data will be collected from participants at three points: before consultation, 2 months and 3 months after consultation.
Mann-Whitney, T-tests and x2 will be used for data analysis
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014012113542N2
Registration date:2014-07-25, 1393/05/03
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-07-25, 1393/05/03
Registrant information
Name
Zohreh Khakbazan
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8898 4339
Email address
khakbazanz871@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2014-02-04, 1392/11/15
Expected recruitment end date
2014-04-20, 1393/01/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of impact of PLISSIT (Permission, Limited Information, Specific Suggestion, Intensive Therapy) model and personal counseling on sexual function in married women suffer from multiple sclerosis with sexual dysfunction
Public title
Comparison of impact of PLISSIT (Permission, Limited Information, Specific Suggestion, Intensive Therapy) model and personal counseling on sexual function in married women suffer from multiple sclerosis with sexual dysfunction
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: women who are married, do not suffer from any other chronic disease, and have sexual problems (FSFI score<28). they should have sexual relationship with their husband.
Exclusion criteria: If a woman does not want to continue take parting in this study or becomes pregnant or does not come to all sessions of intervention, she will be omitted.
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single 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 Tehran University of Medical Sciences
Street address
The 6th floor of The central organization of Tehran University of Medical Sciences, at the corner of Qods Street , Keshavarz street.
City
Tehran
Postal code
Approval date
2013-12-21, 1392/09/30
Ethics committee reference number
130/2187/د/92
Health conditions studied
1
Description of health condition studied
Sexual dysfunction
ICD-10 code
F52
ICD-10 code description
Sexual dysfunction, not caused by organic disorder or disease
Primary outcomes
1
Description
Sexual function
Timepoint
Before the intervention; two monthes and three monthes after intervention
Method of measurement
Female Sexual Function Index questionnare
Secondary outcomes
1
Description
Quality of life
Timepoint
Two monthes and three monthes after intervention
Method of measurement
SF36 questionnaire
Intervention groups
1
Description
The experimental group-A: will receive consultation based on PLISSIT model (Permission-limited Information-Specific Suggestion-Intensive Therapy) by a trained midwife during 4 weeks that in each week one session will be conducted.
Category
Behavior
2
Description
The control group: will receive routine sexual consultation.
Category
Other
3
Description
The experimental groups-B: will receive personal consultation during 4 weeks that in each week one session will be conducted.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Iran Multiple Sclerosis Society
Full name of responsible person
Sahraeean
Street address
Iran Multiple Sclerosis Society, Mohammad Alley, Vesal Street, Enghelab Street, Tehran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Masoud Yonesian
Street address
The 6th Floor of The central organization of Tehran University of Medical Sciences, Qods Street, Keshavarz Street.
City
Tehran
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
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
Tehran University of Medical Sciences
Full name of responsible person
Fatemeh Daneshfar
Position
Master Sciences Student of Midwifary
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery of Tehran University of Medical Sciences, Tohid square, Nosrat Street, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 6694 1669
Fax
Email
daneshfar1987@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Zohreh Khakbazan
Position
Trainar
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery of Tehran University of Medical Sciences, Tohid square, Nosrat Street, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 6694 1669
Fax
Email
khakbazanz871@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Nursing and Midwifary of Tehran University of Medical Sciences
Full name of responsible person
Fatemeh Daneshfar
Position
Master Sciences student of Midwifary
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery of Tehran University of Medical Sciences, Tohid square, Nosrat Street, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21664251684
Fax
Email
daneshfar1987@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)