Determining the effect of EX-PLISSIT-based counseling on sexual self-concept and marital satisfaction of women referring to urban infertility centers.
Design
A Clinical trial with control group, with parallel group design, A blind side, randomized
Settings and conduct
Location of Hazrat Maryam Infertility Center in Sari
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Couples who live together during the research; have a high school education and more; at least 6 months and at most 10 years have passed since the diagnosis of infertility. Non-inclusion Criteria: occurrence of any severe psychological stress such as accident or loss of a loved one during the past 3 months; underlying medical conditions.
Intervention groups
Intervention group: Infertile women who received two 45-minute counseling sessions with one week interval in a safe and comfortable environment based on the PLISSIT-EX model. Control group: Infertile women who were not consulted and completed the questionnaires in only three steps. The sessions were held for control group on request after the end of the study.
Main outcome variables
Marital satisfaction; sexual self-concept
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190309042976N1
Registration date:2020-05-02, 1399/02/13
Registration timing:retrospective
Last update:2020-05-02, 1399/02/13
Update count:0
Registration date
2020-05-02, 1399/02/13
Registrant information
Name
Arezou khodaiyan Krim
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 54 3223 0540
Email address
khodaeian@goums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-01-21, 1397/11/01
Expected recruitment end date
2019-06-22, 1398/04/01
Actual recruitment start date
2019-02-09, 1397/11/20
Actual recruitment end date
2019-07-23, 1398/05/01
Trial completion date
2019-07-23, 1398/05/01
Scientific title
Evaluation the Effectiveness of Counceling based on EX-PLISSIT model on Sexual Self-Concept and Marital Satisfaction in Infertile Women
Public title
The Effect of Counseling based on EX-PLISSIT model on Sexual Self-Concept and Marital Satisfaction
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Couples living together during research (no barriers to the presence of a spouse at home, such as having a job in a city other than the spouse's residence).
Having high school education and more (due to the complexity of the self-concept questionnaire)
At least 6 months and up to 10 years have passed since their infertility was diagnosed
Have no children (primary infertility)
Exclusion criteria:
Any severe psychological stress such as an accident or the loss of a loved one over the past 3 months
Underlying medical conditions such as heart disease, gastrointestinal or respiratory disease, epilepsy, high blood pressure, diabetes, rheumatoid arthritis, or depression (self-reported)
Addiction of each couple to drugs and alcohol (based on self-expression)
Known sexual dysfunction, including vaginismus, premature ejaculation (based on self-expression)
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
80
Actual sample size reached:
81
Randomization (investigator's opinion)
Randomized
Randomization description
Participants in this study will be assigned to two groups by block randomization method (blocks of size 4). The blocks are as follows:Test group: A, Control group: B.
1- AA BB
2- AB AB
3- AB BA
4- BB AA
5- BA BA
6- BA AB
After creating the different states of the blocks of size 4, We produce random numbers 1 to 6 using a regular hexagon. This process will be repeated 24 times. For the selection of a random number, a block of size 4 will be selected, accordingly 2 people will be in the test group and 2 people will be in the control group. At each stage of the study, the number of people assigned to the test and control group is the same.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, participants were kept blind and after completing the first stage questionnaire, they would be informed which of the test or control groups they were in.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Gorgan University of Medical Sciences
Street address
Shast Kola
City
Gorgan
Province
Golestan
Postal code
4663255
Approval date
2019-01-01, 1397/10/11
Ethics committee reference number
IR.GOUMS.REC.1397.199
Health conditions studied
1
Description of health condition studied
Sexual self-concept and marital satisfaction
ICD-10 code
-
ICD-10 code description
-
Primary outcomes
1
Description
Sexual self-concept score on the Snell questionnaire
Timepoint
Before the start of the intervention, one week later and one month after the start of the intervention
Method of measurement
Snell Persian sexual self-concept questionnaires
2
Description
Marital Satisfaction Score in Lee Questionnaire
Timepoint
Before the start of the intervention, one week later and one month after the start of the intervention
Method of measurement
Lee's Persian Marital Satisfaction Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: infertile women receiving counseling. The counseling intervention group was based on the PLISSIT-EX model, during which two one-hour weekly visits were held at Hazrat Maryam Infertility Center. Individual counseling was without the presence of a spouse, and during these sessions, the patient was first told about his or her problems by creating a safe, trustworthy, and non-judgmental environment. The patient was then allowed to talk about his or her marital satisfaction and sexual problems. In the next step, the researcher provided limited information directly related to the client's sexuality and concerns, and provided the patient with information about the anatomy and physiology of the female sexual organ, the stages of the sexual cycle, and sexual function. At the end, the client was offered a specific and problem-solving proposal, and during each step there was feedback to increase self-awareness, and the review process was guided by reviewing, exchanging views and opinions, and discussing patient learning and understanding during counseling.
Category
Other
2
Description
Control group: Infertile women who completed only the questionnaires in three stages and no advice was given to them until the end of the project. At the end of the project, the control group was asked to hold counseling sessions if they wished, and only two people were willing to hold counseling sessions, which were also consulted.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Maryam Infertility Center
Full name of responsible person
Arezou khodaiyan karim
Street address
Moalem
City
Sari
Province
Mazandaran
Postal code
09151868200
Phone
+98 58 3223 0540
Email
a.khodaiyan@mail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Arezo Khodaiyan karim
Street address
Moalem
City
Sari
Province
Mazandaran
Postal code
568420.
Phone
+98 58 3223 0540
Email
a.khodaiyan@mail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Gorgan 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
Gorgan University of Medical Sciences
Full name of responsible person
Arezo Khodaiyan Karim
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Moalem
City
Sari
Province
Mazandaran
Postal code
5346852
Phone
+98 58 3223 0540
Email
a.khodaiyan@mail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Arezo Khodaiyan Karim
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Moalem
City
Sari
Province
Mazandaran
Postal code
58463
Phone
+98 58 3223 0540
Email
a.khodaiyan@mail.com
Person responsible for updating data
Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Arezo Khodaiyan Karim
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Moalem
City
Sari
Province
Mazandaran
Postal code
54268
Phone
+98 58 3223 0540
Email
a.khodaiyan@mail.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