Sexual Counseling According to the PLISSIT Model in Primary Infertile Couples
Primary Purpose
Infertility, Sexuality, Sexual Dysfunction
Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
sexaul counseling
Sponsored by
About this trial
This is an interventional supportive care trial for Infertility
Eligibility Criteria
Inclusion Criteria:
- Sexual dysfunction in infertile men and women (FSFI = 26.55 points and below, ---ASEX≥11 points and above)
- Having been diagnosed with infertility at least a year ago
- Being in the diagnostic test phase
- On the day of vaccination
- After IVF / ICSI-Embryo Transfer
- 18-45 years of age
- Being literate,
Exclusion Criteria:
- Having a chronic disease other than infertility
- With a psychiatric illness
- Have any chronic disease
- Couples with Secondary Infertility
- IVF / ICSI-OPU (Egg pick up)
Sites / Locations
- Ezgi ŞAHİNRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control
Experimental
Arm Description
Infertile couples in the control group were selected by randomization, routine protocols in the clinic were applied
st interview: Application of data collection tools nd meeting: Sexual counseling (1 week after the first interview) rd interview: Sexual counseling (1 week after the first session) th meeting: Sexual counseling (1 week after the second session) th interview: Telephone interview (2 months after the first assessment) th interview: re-application of data collection tools, including the final evaluation
Outcomes
Primary Outcome Measures
The Female Sexual Function Index
The levels of desire, arousal, lubrication, orgasm, satisfaction and sexual pain in women are evaluated in the first and final evaluation
The Female Sexual Function Index
The levels of desire, arousal, lubrication, orgasm, satisfaction and sexual pain in women are evaluated in the first and final evaluation
Arizona Sexual Experiences Scale Male Form
In the first evaluation and in the final evaluation, the sexual function level of men and the sexual problems that arise are evaluated.
Arizona Sexual Experiences Scale Male Form
In the first evaluation and in the final evaluation, the sexual function level of men and the sexual problems that arise are evaluated.
The New Sexual Satisfaction Scale
In the first and final evaluation, the self-centered sub-dimension, which is the first sub-dimension of the scale, measures the level of sexual satisfaction consisting mostly of personal experiences, while in the second sub-dimension, the co-partner / sexual activity-centered sub-dimension, the sexual behavior and reactions of the person's partner and also the diversity of sexual activity and / or the level of sexual satisfaction obtained from the frequency is evaluated.
The New Sexual Satisfaction Scale
In the first and final evaluation, the self-centered sub-dimension, which is the first sub-dimension of the scale, measures the level of sexual satisfaction consisting mostly of personal experiences, while in the second sub-dimension, the co-partner / sexual activity-centered sub-dimension, the sexual behavior and reactions of the person's partner and also the diversity of sexual activity and / or the level of sexual satisfaction obtained from the frequency is evaluated.
Infertility Stress Scale
In the first and last evaluation, stress in the personal sphere, stress in the marital sphere and stress in the social sphere are measured using the Infertility Stress Scale (ISI).
Infertility Stress Scale
In the first and last evaluation, stress in the personal sphere, stress in the marital sphere and stress in the social sphere are measured using the Infertility Stress Scale (ISI).
Beck Depression Inventory
In the first evaluation, various symptoms and severity of depression that may exist in individuals are evaluated.
Secondary Outcome Measures
Full Information
NCT ID
NCT04791683
First Posted
March 7, 2021
Last Updated
March 15, 2021
Sponsor
Istanbul University - Cerrahpasa (IUC)
1. Study Identification
Unique Protocol Identification Number
NCT04791683
Brief Title
Sexual Counseling According to the PLISSIT Model in Primary Infertile Couples
Official Title
The Effect of Sexual Counseling Given to Infertile Couples in Line With PLISSIT Model on Sexual Function and Sexual Satisfaction
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
August 19, 2019 (Actual)
Primary Completion Date
April 20, 2021 (Anticipated)
Study Completion Date
September 30, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul University - Cerrahpasa (IUC)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study was planned to determine the effect of sexual counseling given to primary infertile couples in line with the PLISSIT model on sexual function and sexual satisfaction.
Detailed Description
The study will be conducted in the Infertility clinic of a medical faculty hospital. Couples receiving primary infertility treatment will be included in the study. It is planned to apply "Introductory Information Form, Female Sexual Function Index, Arizona Sexual Experiences Scale Male Form, Beck Depression Scale, New Sexual Satisfaction Scale and Infertility Stress Scale" to the experimental and control groups in the pre-initial evaluation. Within the scope of sexual counseling to be given to the couples in the experimental group in line with the PLISSIT Model; In order to increase the level of sexual function and sexual satisfaction, education of reproductive system anatomy and physiology, providing information about how the infertility process and treatment can affect sexual functions, determining the problems related to sexual health, trying to eliminate the misinformation and myths about sexuality, It is planned to include suggestions such as helping to cope well, alternative sexual intercourse positions according to the needs of the couples, body exploring exercise, sexual organs exploration exercise, masturbation exercise, kegel exercise.
The experimental group will be given an appointment for "sexual counseling" sessions held in 3 sessions at least 1 week apart. Each of these sessions will be completed in 60 minutes. Before the interviews, in line with the literature, "Sexual Counseling Booklet for Infertile Couples" will be prepared. In line with the scope of sexual counseling, the study is planned to be terminated by conducting 5 face-to-face interviews and 1 phone call with the experimental group. In the final evaluation, in order to determine the effects of sexual counseling on sexual health with the experimental group, the 'Introductory Information Form', Female Sexual Function Index, Male Form of Arizona Sexual Experiences Scale, New Sexual Satisfaction Scale and Infertility Stress Scale, at the appointment dates planned on the 3rd month after the first interview. '' The research will be terminated by filling in a face-to-face interview.
The couples in the control group will be interviewed in the second month after the first interview, and on the appointment dates scheduled for the 3rd month after the first interview, '' Introductory Information Form, Female Sexual Function Index, Arizona Sexual Experiences Scale Male Form, New Sexual Satisfaction Scale. and Infertility Stress Scale '' will be filled again with a face-to-face interview, and the research will be terminated.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility, Sexuality, Sexual Dysfunction, Nurse's Role, Infertility; Female, Infertility, Male
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Parallel assignment Randomized controlled experimental study
Masking
Participant
Masking Description
Single (Participant) In the single-blind method,subjects do not know which of the experimental or control goups they were selected and therefore which method was applied to them. The researcher konows the subjects selected for the experimental and control groups, and therefore which method was applied to which subjects.
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Description
Infertile couples in the control group were selected by randomization, routine protocols in the clinic were applied
Arm Title
Experimental
Arm Type
Experimental
Arm Description
st interview: Application of data collection tools
nd meeting: Sexual counseling (1 week after the first interview)
rd interview: Sexual counseling (1 week after the first session)
th meeting: Sexual counseling (1 week after the second session)
th interview: Telephone interview (2 months after the first assessment)
th interview: re-application of data collection tools, including the final evaluation
Intervention Type
Other
Intervention Name(s)
sexaul counseling
Intervention Description
Sexual counseling includes interviews about sexual problems in couples who are in the process of infertility treatment and suggestions for solving these problems.
Primary Outcome Measure Information:
Title
The Female Sexual Function Index
Description
The levels of desire, arousal, lubrication, orgasm, satisfaction and sexual pain in women are evaluated in the first and final evaluation
Time Frame
The first assessment (ie first measurements) of sexual function levels is made on the first day of diagnostic tests for both groups of women attending the infertility clinic.
Title
The Female Sexual Function Index
Description
The levels of desire, arousal, lubrication, orgasm, satisfaction and sexual pain in women are evaluated in the first and final evaluation
Time Frame
The final assessment of sexual function levels (ie the last measurements) is made for women in both groups, on average 12 weeks after the initial assessment.
Title
Arizona Sexual Experiences Scale Male Form
Description
In the first evaluation and in the final evaluation, the sexual function level of men and the sexual problems that arise are evaluated.
Time Frame
The first assessment (ie first measurements) of sexual function levels is made on the first day of diagnostic tests for both groups of men attending the infertility clinic.
Title
Arizona Sexual Experiences Scale Male Form
Description
In the first evaluation and in the final evaluation, the sexual function level of men and the sexual problems that arise are evaluated.
Time Frame
The final assessment of sexual function levels (ie the last measurements) is made for men in both groups, on average 12 weeks after the initial assessment.
Title
The New Sexual Satisfaction Scale
Description
In the first and final evaluation, the self-centered sub-dimension, which is the first sub-dimension of the scale, measures the level of sexual satisfaction consisting mostly of personal experiences, while in the second sub-dimension, the co-partner / sexual activity-centered sub-dimension, the sexual behavior and reactions of the person's partner and also the diversity of sexual activity and / or the level of sexual satisfaction obtained from the frequency is evaluated.
Time Frame
The first assessment of sexual satisfaction levels (ie the first measurements) is made on the first day of diagnostic tests for both male and female groups admitted to the infertility clinic.
Title
The New Sexual Satisfaction Scale
Description
In the first and final evaluation, the self-centered sub-dimension, which is the first sub-dimension of the scale, measures the level of sexual satisfaction consisting mostly of personal experiences, while in the second sub-dimension, the co-partner / sexual activity-centered sub-dimension, the sexual behavior and reactions of the person's partner and also the diversity of sexual activity and / or the level of sexual satisfaction obtained from the frequency is evaluated.
Time Frame
The final assessment of sexual satisfaction levels (ie the last measurements) is made for men and women in both groups, on average, 12 weeks after the initial assessment.
Title
Infertility Stress Scale
Description
In the first and last evaluation, stress in the personal sphere, stress in the marital sphere and stress in the social sphere are measured using the Infertility Stress Scale (ISI).
Time Frame
The first assessment of infertility stress levels (ie the first measurements) is made on the first day of diagnostic tests for both male and female groups attending the infertility clinic.
Title
Infertility Stress Scale
Description
In the first and last evaluation, stress in the personal sphere, stress in the marital sphere and stress in the social sphere are measured using the Infertility Stress Scale (ISI).
Time Frame
The final assessment of infertility stress levels (ie final measurements) is made for men and women in both groups, on average 12 weeks after the initial assessment.
Title
Beck Depression Inventory
Description
In the first evaluation, various symptoms and severity of depression that may exist in individuals are evaluated.
Time Frame
The first assessment of depression levels (ie first measurements) is made on the first day of diagnostic tests for both male and female groups attending the infertility clinic.
10. Eligibility
Sex
All
Gender Based
Yes
Gender Eligibility Description
men and women receiving infertility treatment
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Sexual dysfunction in infertile men and women (FSFI = 26.55 points and below, ---ASEX≥11 points and above)
Having been diagnosed with infertility at least a year ago
Being in the diagnostic test phase
On the day of vaccination
After IVF / ICSI-Embryo Transfer
18-45 years of age
Being literate,
Exclusion Criteria:
Having a chronic disease other than infertility
With a psychiatric illness
Have any chronic disease
Couples with Secondary Infertility
IVF / ICSI-OPU (Egg pick up)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ezgi ŞAHİN, Msc
Phone
+905316961737
Email
ezgishn90@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
İlkay GÜNGÖR SATILMIŞ, Associate professor
Phone
+90 5356464768
Email
ilkay1979@yahoo.com
Facility Information:
Facility Name
Ezgi ŞAHİN
City
Istanbul
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ezgi ŞAHİN, Msc
Phone
+905316961737
Email
ezgishn90@gmail.com
First Name & Middle Initial & Last Name & Degree
İlkay GÜNGÖR SATILMIŞ, associate professor
Phone
+905356464768
Email
ilkay1979@yahoo.com
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
29707931
Citation
Benksim A, Elkhoudri N, Addi RA, Baali A, Cherkaoui M. Difference between Primary and Secondary Infertility in Morocco: Frequencies and Associated Factors. Int J Fertil Steril. 2018 Jul;12(2):142-146. doi: 10.22074/ijfs.2018.5188. Epub 2018 Mar 18.
Results Reference
background
PubMed Identifier
24350570
Citation
Brassard A, Dupuy E, Bergeron S, Shaver PR. Attachment insecurities and women's sexual function and satisfaction: the mediating roles of sexual self-esteem, sexual anxiety, and sexual assertiveness. J Sex Res. 2015;52(1):110-9. doi: 10.1080/00224499.2013.838744. Epub 2013 Dec 18.
Results Reference
background
PubMed Identifier
26985333
Citation
Czyzkowska A, Awruk K, Janowski K. Sexual Satisfaction and Sexual Reactivity in Infertile Women: The Contribution of The Dyadic Functioning and Clinical Variables. Int J Fertil Steril. 2016 Jan-Mar;9(4):465-76. doi: 10.22074/ijfs.2015.4604. Epub 2015 Dec 23.
Results Reference
background
PubMed Identifier
25091932
Citation
Farnam F, Janghorbani M, Raisi F, Merghati-Khoei E. Compare the effectiveness of PLISSIT and sexual health models on women's sexual problems in Tehran, Iran: a randomized controlled trial. J Sex Med. 2014 Nov;11(11):2679-89. doi: 10.1111/jsm.12659. Epub 2014 Aug 5.
Results Reference
background
PubMed Identifier
23829396
Citation
Ferraresi SR, Lara LA, de Sa MF, Reis RM, Rosa e Silva AC. Current research on how infertility affects the sexuality of men and women. Recent Pat Endocr Metab Immune Drug Discov. 2013 Sep;7(3):198-202. doi: 10.2174/18722148113079990009.
Results Reference
background
PubMed Identifier
27456885
Citation
Khakbazan Z, Daneshfar F, Behboodi-Moghadam Z, Nabavi SM, Ghasemzadeh S, Mehran A. The effectiveness of the Permission, Limited Information, Specific suggestions, Intensive Therapy (PLISSIT) model based sexual counseling on the sexual function of women with Multiple Sclerosis who are sexually active. Mult Scler Relat Disord. 2016 Jul;8:113-9. doi: 10.1016/j.msard.2016.05.007. Epub 2016 May 24.
Results Reference
background
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Sexual Counseling According to the PLISSIT Model in Primary Infertile Couples
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