Sexual Counseling According to the PLISSIT Model in Primary Infertile Couples

Infertility Clinical Trial

Official title:

The Effect of Sexual Counseling Given to Infertile Couples in Line With PLISSIT Model on Sexual Function and Sexual Satisfaction

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04791683
• Other study ID #: 13022260-300-108795
• Status: Recruiting
• Phase: N/A
• Start date: August 19, 2019
• Est. completion date: September 30, 2021

Study information

• Verified date: March 2021
• Source: Istanbul University-Cerrahpasa
• Contact: Ezgi SAHIN, Msc
• Phone: +905316961737
• Email: ezgishn90[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: September 30, 2021
• Est. primary completion date: April 20, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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)

Related Conditions & MeSH terms

• Infertility
• Infertility, Female
• Infertility, Male
• Infertility; Female
• Nurse's Role
• Sexual Dysfunction
• Sexuality

Intervention

Other:
• sexaul counseling
Sexual counseling includes interviews about sexual problems in couples who are in the process of infertility treatment and suggestions for solving these problems.

Locations

Country	Name	City	State
Turkey	Ezgi SAHIN	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul University-Cerrahpasa

Country where clinical trial is conducted

Turkey, 

References & Publications (6)

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. — View 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. — View 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. Epub 2015 Dec 23. — View 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. — View Citation

Ferraresi SR, Lara LA, de Sá 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. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 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.
Primary	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 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.
Primary	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 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.
Primary	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 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.
Primary	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 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.
Primary	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 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.
Primary	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).	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.
Primary	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).	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.
Primary	Beck Depression Inventory	In the first evaluation, various symptoms and severity of depression that may exist in individuals are evaluated.	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.