Sexual Counseling According to the PLISSIT Model in Primary Infertile Couples

NCT ID: NCT04791683

Last Updated: 2021-03-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-19

Study Completion Date

2021-09-30

Brief Summary

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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

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Parallel assignment Randomized controlled experimental study
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants
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.

Study Groups

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Control

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

Group Type NO_INTERVENTION

No interventions assigned to this group

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

Group Type EXPERIMENTAL

sexaul counseling

Intervention Type OTHER

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

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Istanbul University - Cerrahpasa

OTHER

Sponsor Role lead

Responsible Party

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Ezgi SAHİN

Msc

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ezgi ŞAHİN

Istanbul, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Ezgi ŞAHİN, Msc

Role: CONTACT

+905316961737

İlkay GÜNGÖR SATILMIŞ, Associate professor

Role: CONTACT

+90 5356464768

Facility Contacts

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Ezgi ŞAHİN, Msc

Role: primary

+905316961737

İlkay GÜNGÖR SATILMIŞ, associate professor

Role: backup

+905356464768

References

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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.

Reference Type BACKGROUND
PMID: 29707931 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24350570 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26985333 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25091932 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23829396 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27456885 (View on PubMed)

Other Identifiers

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13022260-300-108795

Identifier Type: -

Identifier Source: org_study_id

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