Clinical trial NCT04612959: Effect of Psychosexual Caring Program on Sexual Well-being of Infertile Women
Official title: Effect of Psychosexual Caring Program on Sexual Well-being of Infertile Women: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sexuality
Nursing Caries
Infertility, Female
Keywords: psychoeducation program
infertile women
sexual health
sexual well-being
nursing care
Lead sponsor: Akdeniz University
Sponsor class: OTHER
First posted: 2020-11-03
Enrollment: 70
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled double-blind trial
Primary purpose: SUPPORTIVE_CARE

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: change of sexual function
timeFrame: 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.
measure: change of sexual satisfaction
timeFrame: 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. .
measure: change of sexual esteem
timeFrame: 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.
measure: change of sexual self-efficacy
timeFrame: 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 outcomes:
measure: change of sense of coherence
timeFrame: 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.
measure: change of depression
timeFrame: 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 .
Other outcomes:
Locations:
city: Antalya
country: Turkey
facility: Akdeniz University
Study officials:
affiliation: Akdeniz University
name: Kamile Kabukcuoglu
role: STUDY_DIRECTOR
affiliation: Akdeniz University
name: Ayse Deliktas Demirci
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Mendonca 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.
citation: 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.
citation: Martin, K. M., Woodgate, R. L. 2017. "Concept analysis: The holistic nature of sexual well-being", Sexual and Relationship Therapy, 1-15.
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.