Sexual Counseling According to the PLISSIT Model in Primary Infertile Couples

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

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.

Study Overview

• Status: Recruiting
• Conditions: Infertility; Sexual Dysfunction; Infertility, Male; Nurse's Role; Sexuality; Infertility; Female
• Intervention / Treatment: Other: sexaul counseling

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.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ezgi ŞAHİN, Msc; Phone Number: +905316961737; Email: ezgishn90@gmail.com
• Study Contact Backup: Name: İlkay GÜNGÖR SATILMIŞ, Associate professor; Phone Number: +90 5356464768; Email: ilkay1979@yahoo.com

Study Locations

• Turkey
  • Istanbul, Turkey
    • Recruiting
    • Ezgi ŞAHİN
    • Contact: Ezgi ŞAHİN, Msc; Phone Number: +905316961737; Email: ezgishn90@gmail.com
    • Contact: İlkay GÜNGÖR SATILMIŞ, associate professor; Phone Number: +905356464768; Email: ilkay1979@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; Infertile couples in the control group were selected by randomization, routine protocols in the clinic were applied
Experimental: Experimental; 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	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.
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.
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.
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.
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.
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.
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.
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.

Collaborators and Investigators

• Sponsor: Istanbul University - Cerrahpasa (IUC)

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 19, 2019
• Primary Completion (Anticipated): April 20, 2021
• Study Completion (Anticipated): September 30, 2021

Study Registration Dates

• First Submitted: March 7, 2021
• First Submitted That Met QC Criteria: March 7, 2021
• First Posted (Actual): March 10, 2021

Study Record Updates

• Last Update Posted (Actual): March 17, 2021
• Last Update Submitted That Met QC Criteria: March 15, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infertility; Infertility, Female; Infertility, Male
• Other Study ID Numbers: 13022260-300-108795

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No