Clinical trial NCT04791683: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Infertility
Sexuality
Sexual Dysfunction
Nurse's Role
Infertility; Female
Infertility, Male
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
First posted: 2021-03-10
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel assignment Randomized controlled experimental study
Primary purpose: SUPPORTIVE_CARE

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.

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)

Primary outcomes:
measure: The Female Sexual Function Index
timeFrame: 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.
measure: The Female Sexual Function Index
timeFrame: 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.
measure: Arizona Sexual Experiences Scale Male Form
timeFrame: 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.
measure: Arizona Sexual Experiences Scale Male Form
timeFrame: 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.
measure: The New Sexual Satisfaction Scale
timeFrame: 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.
measure: The New Sexual Satisfaction Scale
timeFrame: 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.
measure: Infertility Stress Scale
timeFrame: 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.
measure: Infertility Stress Scale
timeFrame: 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.
measure: Beck Depression Inventory
timeFrame: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Ezgi ŞAHİN
Study officials:
References:
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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.
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.
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.
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.
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.