Determining the Effect of PLISSIT-based Intervention on Sexual Function and Gender Quality of Life in Middle-aged Women
Design
The purpose of this study was to determine the effect of PLISSIT-based intervention on sexual function and sexual quality of life in middle-aged women. This trial is conducted on 100 middle-aged women who are 50 in the group and 50 in the control group. Entry criteria include ages 40-60, married, non-marital, non-physical illness Or psychological and willingness to participate in the study. The intervention is based on the advice of the PLISSITmodel in the 40-60 minute sessions and there is no consultation in the control group. Sexual fitness status was evaluated by FSFI questionnaire and women's sexual quality of life by SQOL-F questionnaire before, after and one month after the intervention. Then, the results or appropriate statistical tests are analyzed and analyzed
Settings and conduct
Tehran,Sampling is carried out in selected centers of Tehran and available in sampling.
Participants/Inclusion and exclusion criteria
Women aged 40-60 and married
Intervention groups
Women aged 40-60 and married
Main outcome variables
sexual function
sexual quality of life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181205041853N1
Registration date:2018-12-17, 1397/09/26
Registration timing:registered_while_recruiting
Last update:2018-12-17, 1397/09/26
Update count:0
Registration date
2018-12-17, 1397/09/26
Registrant information
Name
Naeimeh Shariatifar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8865 5366
Email address
n.shariatifar@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-21, 1397/02/01
Expected recruitment end date
2019-03-21, 1398/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The impact of intervention based in PLISSIT model on sexual function and sexual quality of life of Middle-aged women
Public title
The impact of intervention based in PLISSIT model on sexual function and sexual quality of life of Middle-aged women
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
40-60 years old
married
Exclusion criteria:
Age
From 40 years old to 60 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
simple
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shaihid Beheshti of Medical Sciences
Street address
Ayatollah Taleghani Hospital, Shahid Chamran highway, Yemen street
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2017-07-01, 1396/04/10
Ethics committee reference number
IR.SBMU.PHNM.1396.776
Health conditions studied
1
Description of health condition studied
sexual dغsfunction
ICD-10 code
F52
ICD-10 code description
Sexual dysfunction not due to a substance or known physiological condition
Primary outcomes
1
Description
Sexual function
Timepoint
Before, after the intervention and one month later
Method of measurement
FSFI questionnaire
Secondary outcomes
1
Description
Quality of sexual life
Timepoint
Before, after the intervention and one month later
Method of measurement
SQOL-F questionnaire
Intervention groups
1
Description
Intervention group: Women aged 40-60 years who receive counseling based on the PLISSIT model in middle-aged women. Sexual performance and sexual quality of life will be measured before intervention, after and 1 month after intervention.
Category
Treatment - Other
2
Description
Control group: Middle-aged women between the ages of 40-60 have not received counseling. Sexual performance and sexual quality of life will be measured before intervention, after and 1 month after intervention.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Selected Centers of Tehran
Full name of responsible person
Naeimeh Shariatifar
Street address
Dep of Midwifery ,School of Nursing and Midwifery ,Shahid Beheshti University of Medical Sciences (SBUMs) , Vali Asr street, Niayesh HW Cross Section, Tehran, Tehran province , Iran
City
Teharn
Province
Tehran
Postal code
1985717443
Phone
+98 21 8865 5366
Email
n.shariatifar@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr Mahrokh Dolatian
Street address
Dep of Midwifery ,School of Nursing and Midwifery ,Shahid Beheshti University of Medical Sciences (SBUMs) , Vali Asr street, Niayesh HW Cross Section, Tehran, Tehran province , Iran
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8865 5366
Email
mhdolatian@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Naeimeh Shariatifar
Position
Master of Midwifery
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Dep of Midwifery ,School of Nursing and Midwifery ,Shahid Beheshti University of Medical Sciences (SBUMs) , Vali Asr street, Niayesh HW Cross Section, Tehran, Tehran province , Iran
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8865 5366
Email
n.shariatifar@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Zohreh keshavarz
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
PHD of Reprodactive Health
Street address
Dep of Midwifery ,School of Nursing and Midwifery ,Shahid Beheshti University of Medical Sciences (SBUMs) , Vali Asr street, Niayesh HW Cross Section, Tehran, Tehran province , Iran
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8865 5366
Email
keshavarzzohre@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Naeimeh Shariatifar
Position
Master of Midwifery
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Dep of Midwifery ,School of Nursing and Midwifery ,Shahid Beheshti University of Medical Sciences (SBUMs) , Vali Asr street, Niayesh HW Cross Section, Tehran, Tehran province , Iran
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8865 5363
Email
n.shariatifar@gmail.com
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
Not applicable
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
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available