Sexual Counseling According to the PLISSIT Model in Primary Infertile Couples

Sponsor
Istanbul University-Cerrahpasa (Other)
Overall Status
Recruiting
CT.gov ID
NCT04791683
Collaborator
(none)
60
1
2
25.4
2.4

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: sexaul counseling
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Parallel assignment Randomized controlled experimental studyParallel assignment Randomized controlled experimental study
Masking:
Single (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.
Primary Purpose:
Supportive Care
Official Title:
The Effect of Sexual Counseling Given to Infertile Couples in Line With PLISSIT Model on Sexual Function and Sexual Satisfaction
Actual Study Start Date :
Aug 19, 2019
Anticipated Primary Completion Date :
Apr 20, 2021
Anticipated Study Completion Date :
Sep 30, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. The Female Sexual Function Index [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 levels of desire, arousal, lubrication, orgasm, satisfaction and sexual pain in women are evaluated in the first and final evaluation

  2. The Female Sexual Function Index [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.]

    The levels of desire, arousal, lubrication, orgasm, satisfaction and sexual pain in women are evaluated in the first and final evaluation

  3. Arizona Sexual Experiences Scale Male Form [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.]

    In the first evaluation and in the final evaluation, the sexual function level of men and the sexual problems that arise are evaluated.

  4. Arizona Sexual Experiences Scale Male Form [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.]

    In the first evaluation and in the final evaluation, the sexual function level of men and the sexual problems that arise are evaluated.

  5. The New Sexual Satisfaction Scale [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.]

    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.

  6. The New Sexual Satisfaction Scale [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.]

    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.

  7. Infertility Stress Scale [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.]

    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).

  8. Infertility Stress Scale [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.]

    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).

  9. Beck Depression Inventory [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.]

    In the first evaluation, various symptoms and severity of depression that may exist in individuals are evaluated.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 45 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ezgi ŞAHİN Istanbul Turkey

Sponsors and Collaborators

  • Istanbul University-Cerrahpasa

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Ezgi SAHİN, Msc, Istanbul University-Cerrahpasa
ClinicalTrials.gov Identifier:
NCT04791683
Other Study ID Numbers:
  • 13022260-300-108795
First Posted:
Mar 10, 2021
Last Update Posted:
Mar 17, 2021
Last Verified:
Mar 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 17, 2021