Transformatıonal Learnıng Theory on Infertılıty and Stigma in Infertılıty Women
Primary Purpose
Infertility, Female, Stigma, Social
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
EDUCATIONAL PROGRAM CREATED ACCORDING TO TRANSFORMATIONAL LEARNING THEORY
Sponsored by
About this trial
This is an interventional supportive care trial for Infertility, Female focused on measuring infertility, stigma, educatiıon
Eligibility Criteria
Inclusion criteria for research;
- Being diagnosed with infertility
- Being at least literate
- Be at least 18 years old
- Not having a communication barrier
- Volunteering to participate in the research Exclusion Criteria from the Sample;
- The woman's desire to withdraw from the research
- Not filling out data collection tools
- Unable to reach for training/consulting
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
infertility educatıon group
control group (non-education)
Arm Description
women wıll educate with model about infertility
Routıne care
Outcomes
Primary Outcome Measures
change between the mean score of the Infertility Affected Scale of infertile women who participated in the training program created according to the transformative learning theory and who did not.
Infertility Affect Scale
change between the mean score of the Infertility Stigma (Stigma) Scale of infertile women who participated and did not participate in the training program created according to the transformative learning theory.
Infertility Stigma (Stigma) Scale
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05351567
Brief Title
Transformatıonal Learnıng Theory on Infertılıty and Stigma in Infertılıty Women
Official Title
The Effect of The Educatıonal Program Created Accordıng to Transformatıonal Learnıng Theory on Infertılıty and Stigma in Infertılıty Women
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
May 15, 2022 (Anticipated)
Primary Completion Date
May 15, 2023 (Anticipated)
Study Completion Date
June 15, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Gazi 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
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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility, Female, Stigma, Social
Keywords
infertility, stigma, educatiıon
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
52 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
infertility educatıon group
Arm Type
Experimental
Arm Description
women wıll educate with model about infertility
Arm Title
control group (non-education)
Arm Type
No Intervention
Arm Description
Routıne care
Intervention Type
Other
Intervention Name(s)
EDUCATIONAL PROGRAM CREATED ACCORDING TO TRANSFORMATIONAL LEARNING THEORY
Intervention Description
EDUCATIONAL PROGRAM CREATED ACCORDING TO TRANSFORMATIONAL LEARNING THEORY FOR INFERTILITY FEMALES
Primary Outcome Measure Information:
Title
change between the mean score of the Infertility Affected Scale of infertile women who participated in the training program created according to the transformative learning theory and who did not.
Description
Infertility Affect Scale
Time Frame
9 weeks
Title
change between the mean score of the Infertility Stigma (Stigma) Scale of infertile women who participated and did not participate in the training program created according to the transformative learning theory.
Description
Infertility Stigma (Stigma) Scale
Time Frame
9 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria for research;
Being diagnosed with infertility
Being at least literate
Be at least 18 years old
Not having a communication barrier
Volunteering to participate in the research Exclusion Criteria from the Sample;
The woman's desire to withdraw from the research
Not filling out data collection tools
Unable to reach for training/consulting
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sengül YAMAN SÖZBİR, PhD
Phone
+905069583180
Email
sengul.yaman@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sıdıka PELİT AKSU, PhD
Organizational Affiliation
Gazi University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
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Transformatıonal Learnıng Theory on Infertılıty and Stigma in Infertılıty Women
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