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

Infertility, Female Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04612959
• Other study ID #: AkdenizUniv
• Status: Completed
• Phase: N/A
• Start date: June 11, 2020
• Est. completion date: November 15, 2020

Study information

• Verified date: February 2021
• Source: Akdeniz University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: November 15, 2020
• Est. primary completion date: November 15, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Infertility
• Infertility, Female
• Nursing Caries
• Sexuality

Intervention

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.

Locations

Country	Name	City	State
Turkey	Akdeniz University	Antalya

Sponsors (1)

Lead Sponsor	Collaborator
Akdeniz University

Country where clinical trial is conducted

Turkey, 

References & Publications (5)

Aydin S, Beji NK. Sexual function in infertile couples and the role of infertility counselor. Journal of Education and Research in Nursing. 2013; 10(2): 8-14.

Evans DT. Promoting sexual health and wellbeing: the role of the nurse. Nurs Stand. 2013 Nov 6-12;28(10):53-7; quiz 60. doi: 10.7748/ns2013.11.28.10.53.e7654. — View Citation

Martin, K. M., Woodgate, R. L. 2017. "Concept analysis: The holistic nature of sexual well-being", Sexual and Relationship Therapy, 1-15.

Mendonça CR, Arruda JT, Noll M, Campoli PMO, Amaral WND. Sexual dysfunction in infertile women: A systematic review and meta-analysis. Eur J Obstet Gynecol Reprod Biol. 2017 Aug;215:153-163. doi: 10.1016/j.ejogrb.2017.06.013. Epub 2017 Jun 7. Review. — View Citation

Read SC, Carrier ME, Boucher ME, Whitley R, Bond S, Zelkowitz P. Psychosocial services for couples in infertility treatment: what do couples really want? Patient Educ Couns. 2014 Mar;94(3):390-5. doi: 10.1016/j.pec.2013.10.025. Epub 2013 Nov 5. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change of sexual function	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.
Primary	change of sexual satisfaction	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. .
Primary	change of sexual esteem	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.
Primary	change of sexual self-efficacy	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	change of sense of coherence	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.
Secondary	change of depression	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 .