Effect of Psychosexual Caring Program on Sexual Well-being of Infertile Women

February 10, 2021 updated by: Ayse Deliktas Demirci, Akdeniz University

Effect of Psychosexual Caring Program on Sexual Well-being of Infertile Women: A Randomized Controlled Trial

The present study aims to examine the effect of the psychosexual caring program on the sexual well-being of infertile women.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study will be conducted with 70 infertile women. The intervention group (n = 35) will consist of infertile women who receive a psychosexual caring program, and the control group will consist of infertile women who receive standard care. Standard care includes the information given by the nurse about the treatment methods to be applied once. A total of 4 interviews will be held in the intervention group. In the first interviews, pre-test data will be taken. The psychosexual caring program will be conducted online as a group intervention. The psychosexual caring program includes interventions to promote body awareness, the meaning of sexuality, and marital relationships by gaining communication skills, sexual communication, body knowledge, information about sexual health, and its dimensions. After online interviews with groups, data will be collected for primary and secondary outcomes.

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Antalya, Turkey, 07058
        • Akdeniz University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Having been diagnosed with primary infertility as a result of gynecological evaluation made by experts,
  • Planning an assisted reproductive treatment method for women,
  • Being active in terms of sexual intercourse,
  • Being able to read and write in Turkish,
  • Volunteering to participate in the study

Exclusion Criteria:

  • Having any known illness related to sexual dysfunction (diabetes, hypertension, heart disease, kidney failure and autoimmune and rheumatic diseases),
  • Having a psychiatric diagnosis, •Not having computer or mobile phone and internet access

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Psychosexual care
The psychosexual caring program will be conducted online psychoeducation as a group intervention. The program includes four sessions with home assignments and home readings papers.
Other: Psychosexual care
The psychosexual caring program includes interventions to promote body awareness, the meaning of sexuality, and marital relationships by gaining communication skills, sexual communication, body knowledge, information about sexual health, and its dimensions.The psychosexual caring program includes psycho-education and sexual counseling.
No Intervention: Standard care
Standard care includes the information given by the nurse about the treatment methods to be applied once.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change of sexual function
Time Frame: Data will be collected two times as pre-intervention and immediately post-intervention. After that, change from baseline sexual function at 4 weeks will be assessed.
Sexual function level of infertile women will be measured by The Female Sexual Function Index (FSFI). Outcome will be assessed based on change of sexual function from baseline at 4 weeks.
Data will be collected two times as pre-intervention and immediately post-intervention. After that, change from baseline sexual function at 4 weeks will be assessed.
change of sexual satisfaction
Time Frame: Data will be collected two times as pre-intervention and immediately post-intervention. After that, change from baseline sexual satisfaction at 4 weeks will be assessed. .
Sexual satisfaction of infertile women will be determined by using The Sexual Satisfaction Scale for Women. Outcome will be assessed based on change of sexual satisfaction from baseline at 4 weeks.
Data will be collected two times as pre-intervention and immediately post-intervention. After that, change from baseline sexual satisfaction at 4 weeks will be assessed. .
change of sexual esteem
Time Frame: Data will be collected two times as pre-intervention and immediately post-intervention. After that, change from baseline sexual satisfaction at 4 weeks will be assessed.
Sexual esteem of infertile women will be measured by The Multidimensional Sexuality Questionnaire-Sexual esteem subscale. Outcome will be assessed based on change of sexual esteem from baseline at 4 weeks.
Data will be collected two times as pre-intervention and immediately post-intervention. After that, change from baseline sexual satisfaction at 4 weeks will be assessed.
change of sexual self-efficacy
Time Frame: Data will be collected two times as pre-intervention and immediately post-intervention. After that, change from baseline sexual satisfaction at 4 weeks will be assesed.
Sexual self-efficacy of infertile women will be measured by Sexual Self-Efficacy Scale.Outcome will be assessed based on change of sexual self-efficacy from baseline at 4 weeks.
Data will be collected two times as pre-intervention and immediately post-intervention. After that, change from baseline sexual satisfaction at 4 weeks will be assesed.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change of sense of coherence
Time Frame: Data will be collected two times as pre-intervention and immediately post-intervention. After that, change from baseline sense of coherence at 4 weeks will be assessed.
Sense of coherence of infertile women will be determined by Sense of Coherence Scale.Outcome will be assessed based on change of sense of coherence from baseline at 4 weeks.
Data will be collected two times as pre-intervention and immediately post-intervention. After that, change from baseline sense of coherence at 4 weeks will be assessed.
change of depression
Time Frame: Data will be collected two times as pre-intervention and immediately post-intervention. After that, change from baseline depression at 4 weeks will be assessed .
Depression level of infertile women will be measured by Beck Depression scale.Outcome will be assessed based on change of depression from baseline at 4 weeks.
Data will be collected two times as pre-intervention and immediately post-intervention. After that, change from baseline depression at 4 weeks will be assessed .

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Akdeniz University

Investigators

  • Study Director: Kamile Kabukcuoglu, Akdeniz University
  • Principal Investigator: Ayse Deliktas Demirci, Akdeniz University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 11, 2020

Primary Completion (Actual)

November 15, 2020

Study Completion (Actual)

November 15, 2020

Study Registration Dates

First Submitted

October 27, 2020

First Submitted That Met QC Criteria

November 2, 2020

First Posted (Actual)

November 3, 2020

Study Record Updates

Last Update Posted (Actual)

February 11, 2021

Last Update Submitted That Met QC Criteria

February 10, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AkdenizUniv

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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