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

Primary Purpose

Sexuality, Nursing Caries, Infertility, Female

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Psychosexual care
Sponsored by
Akdeniz University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Sexuality focused on measuring psychoeducation program, infertile women, sexual health, sexual well-being, nursing care

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

  • Akdeniz University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Psychosexual care

Standard care

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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.
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.
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.
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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
October 27, 2020
Last Updated
February 10, 2021
Sponsor
Akdeniz University
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1. Study Identification

Unique Protocol Identification Number
NCT04612959
Brief Title
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

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
June 11, 2020 (Actual)
Primary Completion Date
November 15, 2020 (Actual)
Study Completion Date
November 15, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Akdeniz University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sexuality, Nursing Caries, Infertility, Female
Keywords
psychoeducation program, infertile women, sexual health, sexual well-being, nursing care

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled double-blind trial
Masking
ParticipantOutcomes 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.
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Psychosexual care
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard care
Arm Type
No Intervention
Arm Description
Standard care includes the information given by the nurse about the treatment methods to be applied once.
Intervention Type
Other
Intervention Name(s)
Psychosexual care
Intervention Description
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.
Primary Outcome Measure Information:
Title
change of sexual function
Description
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.
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.
Title
change of sexual satisfaction
Description
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.
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. .
Title
change of sexual esteem
Description
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.
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.
Title
change of sexual self-efficacy
Description
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.
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.
Secondary Outcome Measure Information:
Title
change of sense of coherence
Description
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.
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.
Title
change of depression
Description
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.
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 .

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kamile Kabukcuoglu
Organizational Affiliation
Akdeniz University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Ayse Deliktas Demirci
Organizational Affiliation
Akdeniz University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Akdeniz University
City
Antalya
ZIP/Postal Code
07058
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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.
Results Reference
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PubMed Identifier
28628848
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.
Results Reference
background
PubMed Identifier
24191835
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.
Results Reference
background
Citation
Martin, K. M., Woodgate, R. L. 2017. "Concept analysis: The holistic nature of sexual well-being", Sexual and Relationship Therapy, 1-15.
Results Reference
background
PubMed Identifier
24290241
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.
Results Reference
background

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

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