Determining the effect of counseling based on the PLISSIT model on the quality of sexual life of infertile women with sexual dysfunction
Design
A clinical trial with a control group, with parallel groups, one-sided blind, randomized, 41 samples for each of the test and control groups.
Settings and conduct
The research environment is the Fertility and Infertility Center of Hazrat Maryam Isfahan. Eligible individuals to enter the study who have sexual dysfunction based on FSFI questionnaire will enter the study. These people will be placed in two test and control groups using a table of random numbers. The participants will not know whether they are in the control group or the test group. The SQOLF questionnaire is completed in both groups before the intervention. In the test group, the sexual counseling will be conducted individually based on the PLISSIT model , which will be 4 weekly counseling sessions or more depending on the needs of the participants with 45-60 time. For the control group, an individual counseling session will be held for one hour, and counseling in this group will not be based on a specific model. 4 weeks after the intervention, the FSFI and SQOLF questioner will be completed again in both groups
Participants/Inclusion and exclusion criteria
Age from 18 to 45 , the treatment in the stage before ART, having sexual dysfunction based on the FSFI questionnaire, Not suffering from mental and physical diseases and not taking drugs that affect sexual function
Intervention groups
In the test group, the sexual counseling will be held individually based on the PLISSIT model, which will be 4 weekly counseling sessions or more depending on the needs of the participants with 45-60 time.
Main outcome variables
Counseling based on the plissit model, Quality of sexual life, Sexual function index
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230205057328N1
Registration date:2023-02-14, 1401/11/25
Registration timing:registered_while_recruiting
Last update:2023-02-14, 1401/11/25
Update count:0
Registration date
2023-02-14, 1401/11/25
Registrant information
Name
Reyhane Amini
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 5442 0731
Email address
reyhane.aminiiiiii@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-02-14, 1401/11/25
Expected recruitment end date
2023-07-16, 1402/04/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
effect of the PLISSIT model on the sexual quality of life in infertile women with sexual dysfunction
Public title
effect of the PLISSIT model on the sexual quality of life in infertile women with sexual dysfunction
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Be Iranian
Age range from 18 to 45 years
Having at least reading and writing literacy
The treatment process of infertile women should be in the stage before assisted reproductive treatments
having sexual dysfunction based on the score obtained from the standard FSFI questionnaire (score less than 28 from the FSFI questionnaire)
Exclusion criteria:
Husband suffering from erectile dysfunction and premature ejaculation
suffering from known mental and physical diseases affecting sexual function such as diabetes, hypertension, rheumatoid arthritis, depression, etc. based on the documents included in the patient's file
taking drugs that affect sexual function, such as cardiac drugs and beta blockers, H2 blockers, antidepressants, anticholinergics, and continuous use of antihistamines based on the patient's statements or the documents included in the patient's file
history of participation in training classes or counseling sessions focused on sexual performance
Age
From 18 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
82
Randomization (investigator's opinion)
Randomized
Randomization description
For random allocation, using the table of random numbers, people will be placed in two groups, test and control, in such a way that if they receive an even number from this table, they will be placed in the test group, and if they receive an odd number, they will be placed in the control group.
Blinding (investigator's opinion)
Single blinded
Blinding description
The participants will be placed in the test and control groups based on the random number table. In the test group, there will be 4 weekly counseling sessions based on the PLISSIT model. The control group will receive one hour of individual sex counseling. After 4 weeks, both groups will complete the FSFI and SQOLF questionnaires. During this period, the participants are not aware that they are in the control group or the test group.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Faculty of Nursing, Management and Rehabilitation - Isfahan University of Medica
Street address
Isfahan University of Medical Sciences, Hazar Jarib Street, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2023-01-28, 1401/11/08
Ethics committee reference number
IR.MUI.NUREMA.REC.1401.148
Health conditions studied
1
Description of health condition studied
Sexual dysfunction
ICD-10 code
F52
ICD-10 code description
Sexual dysfunction not due to a substance or known physiological condition
2
Description of health condition studied
Infertility
ICD-10 code
N97
ICD-10 code description
Female infertility
Primary outcomes
1
Description
Sexual quality of life
Timepoint
Before the intervention and 4 weeks after the intervention
Method of measurement
Sexual quality of life -female questionnaire
2
Description
Sexual function index
Timepoint
Before the intervention and 4 weeks after the intervention
Method of measurement
Female sexual function index questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Individual sexual counseling based on the 4 steps of the PLISSIT model in the form of 4 weekly counseling sessions or more depending on the needs of the participants with a time of 45-60 minutes.
Category
Treatment - Other
2
Description
Control group: Individual counseling session for one hour without using counseling models
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Hazrat Maryam fertility and Infertility Center,
Full name of responsible person
Mahboube Taebi
Street address
Motahari St., Shahid Beheshti Hospital, Hazrat Maryam Fertility Center
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3441 0668
Fax
Email
m_taebi@nm.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Gholamreza Asgari
Street address
Hezar jerib st, Azadi Square
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 3071
Email
reyhane.aminiiiiii@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Reyhaneh Amini
Position
Master student of midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Hazar Jarib Street, Isfahan University of Medical Sciences
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 3071
Email
reyhane.aminiiiiii@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mahboube Taebi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Hazar Jarib Street, Isfahan University of Medical Sciences
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 3071
Email
m_taebi@nm.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Reyhane Amini
Position
Master student of midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Hazar Jarib Street, Isfahan University of Medical Sciences
City
Isfahan
Province
Isfehan
Postal code
817467346
Phone
+98 31 3792 3071
Email
reyhene.aminiiiiii@gmail.com
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