Determining the effectiveness of counseling based on the PLISSIT on postmenopausal women sexual function and satisfaction
Design
A clinical trial with a control group, with parallel groups, randomized, was performed on 60 married postmenopausal women.
Settings and conduct
The participants who obtained a score of < 28 on the FSFI index were allowed to enter the study. Participants randomly assigned to two groups of educational counseling intervention with PLISSIT method or educational pamphlet.
The study was double-blind. Random allocation and data analysis was done by assistants who were not involved in data collection.
Participants/Inclusion and exclusion criteria
Inclusion: married postmenopausal women - menopause at least one year
Exclusion:suffering from medical diseases - husband's sexual dysfunction
Intervention groups
Intervention group: individually received sexual counseling based on the PLISSIT model in a session of 60–90 min for 4 weeks. Session 1: The participants' problems were discussed. Session 2: The therapist gave limited information about the participant's concerns. Session 3: The participant was given specific suggestions to enable her to manage her sexual problems. Session 4: Focused counseling was conducted by a team psychologist. Control group: Received a pamphlet about women's sexual function, menopausal physiological changes and the effect of menopausal physiological changes on women's sexual function in simple and understandable terms.
Main outcome variables
Sexual satisfaction; Sexual function
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20110523006575N7
Registration date:2023-09-02, 1402/06/11
Registration timing:retrospective
Last update:2023-09-02, 1402/06/11
Update count:0
Registration date
2023-09-02, 1402/06/11
Registrant information
Name
Ashraf Direkvand-Moghadam
Name of organization / entity
Ilam University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 84 3222 7134
Email address
direkvand-a@medilam.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-09-11, 1398/06/20
Expected recruitment end date
2020-07-10, 1399/04/20
Actual recruitment start date
2019-07-11, 1398/04/20
Actual recruitment end date
2020-09-10, 1399/06/20
Trial completion date
2020-09-10, 1399/06/20
Scientific title
The effect of counseling based on PLISSIT model on satisfaction and sexual function of postmenopausal women: A randomized controlled clinical trial
Public title
The effect of counseling based on PLISSIT model on satisfaction and sexual function of postmenopausal women
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Married postmenopausal women
Menopause for at least a year
Exclusion criteria:
Medical disease
Husband's sexual dysfunction
Age
From 40 years old to 60 years old
Gender
Female
Phase
N/A
Groups that have been masked
Investigator
Data analyser
Sample size
Target sample size:
60
Actual sample size reached:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Quadruple Permutation Block Randomization. all possible blocks were arranged as follows. Block 1: ABAB Block 2: AABB Block 3: ABBA Block 4: BBAA Block 5 BABA Block 6:BAAB. 15 blocks were needed to select 60 people. These blocks were chosen randomly from 1 to 6. Using R software, a random number between 1 and 6 was selected. For example, if number 4 was chosen as the first block and number 1 as the second block, the people who entered the study would be given the order BBAAABAB.
Blinding (investigator's opinion)
Double blinded
Blinding description
Random assignment in groups was done by an assistant who was not involved in data collection.
Data analysis was done by an assistant who was not involved in data collection
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committee of Ilam University of Medical Sciences
Street address
End of Pajouhesh Blvd, Ilam - Iran
City
Ilam
Province
Ilam
Postal code
6939177143
Approval date
2019-07-15, 1398/04/24
Ethics committee reference number
IR.MEDILAM.REC.1398.067
Health conditions studied
1
Description of health condition studied
Sexual function
ICD-10 code
F52.9
ICD-10 code description
Unspecified sexual dysfunction, not caused by organic disorder or disease
Primary outcomes
1
Description
Sexual function
Timepoint
At the beginning of the study and four and eight weeks after the end of the study
Method of measurement
Standard Sexual Function Questionnaire
Secondary outcomes
1
Description
Sexual satisfaction
Timepoint
At the beginning of the study and four and eight weeks after the end of the educational intervention in the intervention group or educational pamphlet in the control group
Method of measurement
Standard Sexual satisfaction Questionnaire
Intervention groups
1
Description
Control group: Received a pamphlet about women's sexual function, menopausal physiological changes and the effect of menopausal physiological changes on women's sexual function in simple and understandable terms
Category
Behavior
2
Description
Intervention group: individually received sexual counseling based on the PLISSIT model in a session of 60–90 min for 4 weeks.Session 1: The participants' problems were discussed. The participant was allowed to talk about his sexual performance function. It was possible that the participant's statements were in conflict with the therapist's beliefs and attitude.Session 2: The therapist gave limited information about the participant's concerns. It was educational information that was directly related to the participant's sexual problems and concerns. Session 3: The participant was given specific suggestions to enable her to manage her sexual problems. Session 4: Focused counseling was conducted by a team psychologist.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Health care center number 6
Full name of responsible person
zainab sadoghi
Street address
Modares Boul, Keshvari Square
City
Ilam
Province
Ilam
Postal code
6631165357
Phone
+98 84 3222 8268
Fax
Email
Bekh87@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ilam University of Medical Sciences
Full name of responsible person
Dr. Abbas Maleki
Street address
End of Pajouhesh Blvd, Ilam - Iran
City
Ilam
Province
Ilam
Postal code
6939177143
Phone
+98 84 3223 5724
Email
maleki-a@medilam.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ilam 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
Ilam University of Medical Sciences
Full name of responsible person
ِDr. Direkvand-Moghadam, Ashraf
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Pajouhesh Blvd, Ilam - Iran
City
Ilam
Province
Ilam
Postal code
6939177143
Phone
+98 84 3224 6527
Email
direkvand-a@medilam.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ilam University of Medical Sciences
Full name of responsible person
Dr. Direkvand-Moghadam, Ashraf
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Pajouhesh Blvd, Ilam - Iran
City
Ilam
Province
Ilam
Postal code
6939177143
Phone
+98 84 3224 6527
Email
direkvand-a@medilam.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Ilam University of Medical Sciences
Full name of responsible person
Dr. Direkvand-Moghadam, Ashraf
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Pajouhesh Blvd, Ilam - Iran
City
Ilam
Province
Ilam
Postal code
6939177143
Phone
+98 84 3224 6527
Email
direkvand-a@medilam.ac.ir
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
Yes - There is a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
After individuals de-identifying, all data can be shared .
When the data will become available and for how long
The results will be available up to 6 months after publish.
To whom data/document is available
Sponsors - Applicant researchers
Under which criteria data/document could be used
Sponsors to prepare related documents - Researchers design future studies
From where data/document is obtainable
Dr. Direkvand-Moghadam, Ashraf
What processes are involved for a request to access data/document
In order to access data or documents, the necessary action will be taken one week after sending the request email.