The effectiveness of sexual counseling based on PLISSIT(Permission- Limited Information- Specific Suggestion- Intensive Therapy) model on sexual function and satisfaction in menopausal women
Objective: A clinical trial, with block randomization design, to determine the effectiveness of sexual counseling based on PLISSIT model on sexual function and satisfaction in menopausal women.
Study population: Menopausal women with age between 45 to 65 years old.
Inclusion criteria: Having less one sexual problems; no having vaginal and cervical infection; no having serious physiological problem; menopausal women; women age between 45 to 65 years old; married and having an intact marriage.
Exclusion criteria: Alcohol, drug and other psychotropic drugs abuse; having severe mental disorder; unsavory life event occurrence.
Sample size: 50 cases.
Study intervention: Menopausal women receiving consultation based on PLISSIT model (Permission-limited Information-Specific Suggestion-Intensive Therapy) in two 1.5-hour sessions.
Study outcome: Evaluation of sexual function based on PLISSIT model in menopausal women in comparison with the control group. Evaluation of sexual function and satisfaction based on FSFI model, scores of sexual function and satisfaction will be assessed one and two months post-intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015113025304N1
Registration date:2016-03-19, 1394/12/29
Registration timing:prospective
Last update:
Update count:0
Registration date
2016-03-19, 1394/12/29
Registrant information
Name
Mahboobeh Belbasi
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 3859 1511
Email address
belbasim911@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research, Mashhad University of Medical Sciences
Expected recruitment start date
2016-05-25, 1395/03/05
Expected recruitment end date
2016-09-23, 1395/07/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of sexual counseling based on PLISSIT(Permission- Limited Information- Specific Suggestion- Intensive Therapy) model on sexual function and satisfaction in menopausal women
Public title
The effectiveness of sexual counseling based on PLISSIT model on menopausal women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Having less one sexual problems; no having vaginal and cervical infection; no having serious physiological problem; menopausal women; women age between 45 to 65 years old; married and having an intact marriage.
Exclusion criteria: Alcohol, drug and other psychotropic drugs abuse; having severe mental disorder; unsavory life event occurrence.
Age
From 45 years old to 65 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
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
Ethics Committee of Mashhad University of Medical Sciences
Street address
Vice Chancellor for Research, Mashhad University of Medical Sciences, Ghoreishi building, Daneshgah Street, Mashhad
City
Mashhad
Postal code
Approval date
2015-05-23, 1394/03/02
Ethics committee reference number
IR.MUMS.REC.1394.138
Health conditions studied
1
Description of health condition studied
Sexual problem
ICD-10 code
F52
ICD-10 code description
Sexual dysfunction,not caused by organic disorder or disease
Primary outcomes
1
Description
Sexual function
Timepoint
At baseline, one and two months post-intervention.
Method of measurement
FSFI questionnaire
Secondary outcomes
1
Description
Sexual satisfaction
Timepoint
At baseline, one and two months post-intervention.
Method of measurement
Question sexual satisfaction
Intervention groups
1
Description
Intervention group: menopausal women with age between 45 to 65 years receiving consultation based on PLISSIT model in two 1.5-hour sessions. Scores of sexual function and satisfaction will assess one and two months post-intervention.
Category
Treatment - Other
2
Description
Control group: menopausal women with age between 45 to 65 years not receiving consultation. Scores of sexual function and satisfaction will assess one and two months post.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Danesh Amuz Health Center-Mashhad
Full name of responsible person
Mahboobeh Belbasi
Street address
Ebne Sina Avenue, Doktora Crossroads
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research, Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Vice Chancellor for Research, Mashhad University of Medical Sciences, Ghoreishi building, Daneshgah Street, Mashhad
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research, Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Mahboobeh Belbasi
Position
Postgraguate Midwifery Student
Other areas of specialty/work
Street address
Ebne Sina Avenue, Doktora Crossroads
City
Mashhad
Postal code
Phone
+98 51 3859 1511
Fax
Email
Belbasim911@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
khadigeh Mirzaiinamabadi
Position
Associate professor
Other areas of specialty/work
Street address
Ebne Sina Avenue, Doktora Crossroads
City
Mashhad
Postal code
Phone
+98 51 3859 1511
Fax
Email
MirzaiiKh@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mahboobeh Belbasi
Position
Postgraguate Midwifery Student
Other areas of specialty/work
Street address
Ebne Sina Avenue, Doktora Crossroads
City
Mashhad
Postal code
Phone
00
Fax
Email
belbasim911@mums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)