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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
Gazi University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Infertility, Female focused on measuring infertility, stigma, educatiıon

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

    First Posted
    March 31, 2022
    Last Updated
    April 22, 2022
    Sponsor
    Gazi University
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    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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