Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT05351567 |
| Other study ID # |
77082166-604 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
May 15, 2022 |
| Est. completion date |
June 15, 2023 |
Study information
| Verified date |
April 2022 |
| Source |
Gazi University |
| Contact |
Sengül YAMAN SÖZBIR, PhD |
| Phone |
+905069583180 |
| Email |
sengul.yaman[@]hotmail.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
This study will be conducted to evaluate the effect of the education program created
according to the transformational learning theory on women being affected by infertility and
feeling stigmatized due to infertility.
The research is a single center parallel group simple randomized controlled trial. The sample
consisted of 52 participants in total.
determined to be formed. Diagnosed with infertility, literate, 18 years of age and older, no
communication disability, and Women who volunteer to participate will be included in the
study. Personal Information Form, Infertility Affected Scale and Infertility Stigma (Stigma)
Scale will be used to collect data. Groups of 3-10 people were formed for the women in the
experimental group.
A training program consisting of four modules will be implemented once a week. Data analysis
in SPSS 22.0 package program will be.
Description:
Nurses have important duties in providing counseling and support to infertile individuals
during this crisis, which is very difficult to cope with. In this context, nurses should
provide psychosocial care that will enable the individual to accept and cope with the current
process. This study will be conducted to evaluate the effect of the education program created
according to the transformational learning theory on women being affected by infertility and
feeling stigmatized due to infertility. The study was planned as a single-center parallel
group simple randomized controlled trial. The population of the study will be women who
applied to Tatvan Maternity and Children's Hospital due to infertility between
22/05/2022-22/05/2023. Power analysis was performed to determine the number of samples. For
this, the information in a similar study (Infertility Stigma Scale Experiment Mean:
38.67±4.75, Control Mean: 69.76±4.5) was used as a reference. Analysis was done in G power
version 3.1. The minimum number of participants required to be included in each group was
determined as 22, with a total of 44 (α=0.05, 1-β=0.95). However, considering the loss rate
(21.77%) in the reference study, the total number of participants was increased by 20% to 52
(experimental: 26, control: 26). Personal Information Form, Infertility Affected Scale and
Infertility Stigma (Stigma) Scale will be used to collect data. Application First of all, the
aim and content of the research will be explained to the women. Their compliance with the
sampling inclusion criteria will be evaluated. Afterwards, women who agreed to participate in
the study will have an informed consent form signed. Personal information form and pre-tests
(Infertility Affect Scale and Infertility Stigma Scale) will be applied to women. Then, the
women will be randomly randomized to assign the experimental and control groups. Contact
information (Phone numbers and e-mail addresses) will be taken at the first encounter.
Experimental Group Application
A training program consisting of four modules created according to Transformational Learning
Theory will be applied once a week to the women in the experimental group by forming groups
of 3-10 people. Post-tests (Infertility Affect Scale and Infertility Stigma Scale) will be
applied within 1 week after the training is over and in the 4th week after that. The training
modules and the training methods to be used in the modules are given below:
Module 1: Infertility Based on Gender Patterns: Meaning structures of "femininity",
"motherhood" and "infertility" in society Dating activity, brainstorming, discussion over
experiences, critical reflection Module 2: Violence due to infertility (The Concept of
Stigma): Domestic and Social Pressure/Violence Introductory activity, role-play, sharing
feelings, discussion over experiences, critical reflection Module 3: Punishment and exposure
to traditional practices for infertility Introductory activity, watching the movie,
interpreting the movie through experiences, critical reflection Module 4: Interpreting the
awareness experienced in the education process and sharing future plans Introductory
activity, presentation (by women), peer review Control group application The post-tests
(Infertility Affect Scale and Infertility Stigma Scale) will be applied to the women in the
control group 5 weeks after the pre-test application and 4 weeks after this application.
