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

Sponsor

Akdeniz University (Other)

Overall Status

Completed

CT.gov ID

NCT04612959

Collaborator

(none)

Enrollment

Location

Arms

5.2

Actual Duration (Months)

13.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Sexuality Nursing Caries Infertility, Female	Other: Psychosexual care	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

70 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Randomized controlled double-blind trialRandomized controlled double-blind trial

Masking:

Double (Participant, Outcomes Assessor)

Masking Description:

The women which participated in the study will not know which group she was in. The data from the groups will be collected by an online survey and the participants will fill form themselves. And data will retreated from the online database by the person who will nt know groups of participants.

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Jun 11, 2020

Actual Primary Completion Date :

Nov 15, 2020

Actual Study Completion Date :

Nov 15, 2020

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

change of sexual function [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.
change of sexual satisfaction [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.
change of sexual esteem [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.
change of sexual self-efficacy [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.

Secondary Outcome Measures

change of sense of coherence [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.
change of depression [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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