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

NCT04612959 | Completed

• 1 other identifier: AkdenizUniv
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Sexuality; Nursing Caries; Infertility, Female

Keywords

psychoeducation program; infertile women; sexual health; sexual well-being; nursing care

Outcome Measures

Primary Outcomes (4)

• 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.

• 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. .

• 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.

• 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 Outcomes (2)

• 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.

• 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 .

Study Arms (2)

Psychosexual care

EXPERIMENTAL

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

Standard care

NO INTERVENTION

Standard care includes the information given by the nurse about the treatment methods to be applied once.

Interventions

Psychosexual care OTHER

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.

Psychosexual care

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Akdeniz University: lead

Study Sites (1)

Akdeniz University

Antalya, 07058, Turkey (Türkiye)

Location

Related 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.

  BACKGROUND

• 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.

  PMID: 28628848 BACKGROUND

• 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.

  PMID: 24191835 BACKGROUND

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

  BACKGROUND

• 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.

  PMID: 24290241 BACKGROUND

MeSH Terms

Conditions

Sexuality; Infertility, Female

Condition Hierarchy (Ancestors)

Sexual Behavior; Behavior; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Infertility

Study Officials

• Kamile Kabukcuoglu

  Akdeniz University

  STUDY DIRECTOR

• Ayse Deliktas Demirci

  Akdeniz University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Model Details: Randomized controlled double-blind trial

Study Record Dates

• First Submitted: October 27, 2020
• First Posted: November 3, 2020
• Study Start: June 11, 2020
• Primary Completion: November 15, 2020
• Study Completion: November 15, 2020
• Last Updated: February 11, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)