A comparative study of the effect of sex counseling based on PLISSIT model and based on mindfulness on sexual satisfaction and sexual self-efficacy in infertile women
A comparative study of the effect of sex counseling based on the PLISSIT model and based on mindfulness on sexual satisfaction and sexual self-efficacy in infertile women
Design
This randomized clinical trial design is a parallel and non-blind design. This randomized study will be performed on 80 infertile women referred to the Ghaem Health Center of Khorramabad. Simple random methods are used for randomization and participants are assigned to two intervention groups.
Settings and conduct
This study, which will be performed at the Ghaem Health Center of Khorramabad, is non-blinded. Patients will be provided with sexual satisfaction and sexual self-efficacy questionnaires before the intervention and at the end of the intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Conscious and written desire and satisfaction of the participants to participate in the research, Infertility due to female issues, At least two years history of primary infertility, A minimum level of literacy at least the end of primary education, Access to cyberspace (mobile phone equipped with WhatsApp software).
Exclusion criteria: Drug, alcohol, and psychotropic substance abuse (Based on participants' statements), Known mental disorder
Intervention groups
The first intervention group will receive sexual counseling based on the PLISSIT model on a weekly basis for 8 sessions of 45-50 minutes.
The second intervention group will receive mindfulness-based sexual counseling on a weekly basis for 8 sessions of 90 minutes.
Main outcome variables
Sexual satisfaction; Sexual self-efficacy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130812014333N172
Registration date:2021-08-03, 1400/05/12
Registration timing:prospective
Last update:2021-08-03, 1400/05/12
Update count:0
Registration date
2021-08-03, 1400/05/12
Registrant information
Name
Feizollah Foroughi
Name of organization / entity
kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1821 4653
Email address
fforoughi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-09-06, 1400/06/15
Expected recruitment end date
2021-11-06, 1400/08/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparative study of the effect of sex counseling based on PLISSIT model and based on mindfulness on sexual satisfaction and sexual self-efficacy in infertile women
Public title
Comparison of two treatments on sexual satisfaction and sexual self-efficacy in infertile women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Conscious and written desire and satisfaction of the participants to participate in the research
Infertility due to female issues
At least two years history of primary infertility
A minimum level of literacy at least the end of primary education
Access to cyberspace (mobile phone equipped with WhatsApp software)
Exclusion criteria:
Drug, alcohol, and psychotropic substance abuse (Based on participants' statements)
Known mental disorder
Age
From 17 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be done in a simple random method, after identifying eligible patients, they will be randomly assigned a three-digit dedicated code. The last digit on the right determines the patient group. If this number is 0, 1, 2, 3, 4, it will be assigned in the first intervention group, and if this number is 5, 6, 7, 8, 9, it will be assigned in the second intervention group
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 Kermanshah University of Medical Sciences
Street address
Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences, Building No.2, Shahid Beheshti Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Approval date
2021-06-29, 1400/04/08
Ethics committee reference number
IR.KUMS.REC.1400.281
Health conditions studied
1
Description of health condition studied
infertility
ICD-10 code
N97
ICD-10 code description
Female infertility
Primary outcomes
1
Description
Sexual Satisfaction
Timepoint
Beginning and end of the study
Method of measurement
Based on the Sexual Satisfaction Questionnaire
2
Description
Sexual Self-Efficacy
Timepoint
Beginning and end of the study
Method of measurement
Based on the Sexual Self-Efficacy Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
The first intervention group will receive sexual counseling based on the PLISSIT model on a weekly basis for 8 sessions of 45-50 minutes.
Category
Other
2
Description
The second intervention group will receive mindfulness-based sexual counseling on a weekly basis for 8 sessions of 90 minutes.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Ghaem Health Center
Full name of responsible person
Zeynab Norizadeh
Street address
Ghaziabad, 10th Street
City
Khoramabad
Province
Kermanshah
Postal code
6712312132
Phone
+98 66 3340 2443
Email
m.h.khorramabad @lums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Reza Khodarahmi
Street address
Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences, Building No.2, Shahid Beheshti Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3836 0014
Email
rkhodarahmi@mbrc.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Marzieh Kaboudi
Position
Faculty member of Kermanshah University of Medical Sciences
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Isar Square, School of Nursing and Midwifery
City
Kermanshah
Province
Kermanshah
Postal code
6714869914
Phone
+98 83 3816 2535
Email
fkaboudi@kums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Marzieh Kaboudi
Position
Faculty member of Kermanshah University of Medical Sciences
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Isar Square, School of Nursing and Midwifery
City
Kermanshah
Province
Kermanshah
Postal code
6714869914
Phone
+98 83 3816 2535
Email
fkaboudi@kums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Marzieh Kaboudi
Position
Faculty member of Kermanshah University of Medical Sciences
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Isar Square, School of Nursing and Midwifery
City
Kermanshah
Province
Kermanshah
Postal code
6714869914
Phone
+98 83 3816 2535
Email
fkaboudi@kums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD