Sexual Counseling According to the PLISSIT Model in Primary Infertile Couples

NCT04791683 | Unknown DMC

• 1 other identifier: 13022260-300-108795
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (9)

• 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.

Study Arms (2)

Control

NO INTERVENTION

Infertile couples in the control group were selected by randomization, routine protocols in the clinic were applied

Experimental

EXPERIMENTAL

1. st interview: Application of data collection tools 2. nd meeting: Sexual counseling (1 week after the first interview) 3. rd interview: Sexual counseling (1 week after the first session) 4. th meeting: Sexual counseling (1 week after the second session) 5. th interview: Telephone interview (2 months after the first assessment) 6. th interview: re-application of data collection tools, including the final evaluation

Other: sexaul counseling

Interventions

sexaul counseling OTHER

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

Experimental

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: men and women receiving infertility treatment
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• years of age
• Being literate,

You may not qualify if:

• 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)

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead

Study Sites (1)

Ezgi ŞAHİN

Istanbul, Turkey (Türkiye)

RECRUITING

Related 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.

  PMID: 29707931 BACKGROUND

• 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.

  PMID: 24350570 BACKGROUND

• 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.

  PMID: 26985333 BACKGROUND

• 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.

  PMID: 25091932 BACKGROUND

• 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.

  PMID: 23829396 BACKGROUND

• 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.

  PMID: 27456885 BACKGROUND

MeSH Terms

Conditions

Infertility; Sexuality; Sexual Dysfunction, Physiological; Infertility, Female; Infertility, Male

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases; Sexual Behavior; Behavior; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Genital Diseases, Male; Male Urogenital Diseases

Central Study Contacts

Ezgi ŞAHİN, Msc

CONTACT

+905316961737; ezgishn90@gmail.com

İlkay GÜNGÖR SATILMIŞ, Associate professor

CONTACT

+90 5356464768; ilkay1979@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Msc

Model Details: Parallel assignment Randomized controlled experimental study

Study Record Dates

• First Submitted: March 7, 2021
• First Posted: March 10, 2021
• Study Start: August 19, 2019
• Primary Completion: April 20, 2021
• Study Completion: September 30, 2021
• Last Updated: March 17, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)