Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT05413629 |
Other study ID # |
Duzce U |
Secondary ID |
hilalkaradeniz1 |
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
April 1, 2022 |
Est. completion date |
December 30, 2022 |
Study information
Verified date |
February 2024 |
Source |
Duzce University |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
In the study, it is aimed to reduce the infertility stress level of women undergoing
infertility treatment, to increase the level of coping with infertility stress, to increase
infertility self-efficacy, to evaluate the usability of web-based education in the field of
infertility, to increase the effectiveness and quality of education by integrating web-based
education into the nursing care process, and continuous traceability, to prevention of
possible wrong treatment process management in the field of infertility, to prevention of
possible loss of cycles and to prevention the material and moral couple from being adversely
affected by this process.
Method: The study was planned to be carried out between 20.01.2022 and 01.06.2023 with women
between the ages of 23-39 who applied to Düzce University Health Practice and Research
Center, Infertility Polyclinic. In the research, the Solomon four-group design sample design
consisting of two experimental and two control groups will be used. The study planned to
consist of a total of 132 patients, 33 patients in each group, taking into account possible
data losses. By design, all of the pre-test and post-test measurement tools will be applied
to the first experimental and control group, and only the post-test measurement tools will be
applied to the second experimental and control group. Randomization will be applied in
determining the experimental and control groups. The data will be collected using Personal
Information Form (Appendix-1), Infertility Stress Scale (ISS) (Appendix 2), Coping with the
Infertility Stress Scale (CISS) (Appendix-3), and Infertility Self-Efficacy Scale - Short
Form (ISE-SF) (Appendix 4). Research data will be collected in approximately day 24 to 27
days for each patient from the initiation of Controlled Ovarian Stimulation (COS) treatment
to pregnancy determination of patients planned for intrauterine insemination (IUI) treatment.
Web-based training is 60 minutes in total, including 4 modules. The web-based training
content includes general information about fertility, infertility diagnosis-treatment
methods, drugs used in IUI treatment and its application, and issues to be considered after
IUI.
Description:
Infertility is defined as the inability to conceive or to continue the pregnancy, despite
having unprotected sexual intercourse at least twice a week for a year and at least twice a
week. It is reported that more than 80 million people around the world are unable to have
children due to medical reasons, and 15% of couples in Turkey are diagnosed with infertility.
When we look at the literature, it is suggested that infertility and assisted reproduction
treatments cause an increase in the level of stress, depression and anxiety in individuals
and that it is necessary to strengthen their coping with this process.
Aim: This study was planned as a randomized controlled experimental study in order to examine
the effect of web-based education about the treatment process on the level of coping with
infertility stress and infertility self-efficacy to women undergoing Intrauterine
Insemination (IUI) treatment.
Objective: In the study, it is aimed to reduce the infertility stress level of women
undergoing infertility treatment, to increase the level of coping with infertility stress, to
increase infertility self-efficacy, to evaluate the usability of web-based education in the
field of infertility, to increase the effectiveness and quality of education by integrating
web-based education into the nursing care process, and continuous traceability, to prevention
of possible wrong treatment process management in the field of infertility, to prevention of
possible loss of cycles and to prevention the material and moral couple from being adversely
affected by this process.
Method: The study was planned to be carried out between 20.01.2022 and 01.06.2023 with women
between the ages of 23-39 who applied to Düzce University Health Practice and Research
Center, Infertility Polyclinic. In the research, the Solomon four-group design sample design
consisting of two experimental and two control groups will be used. Power analysis (G*Power
3.1.9.2) was performed on the basis of a previous similar research in the selection of the
sample. Accordingly, the sample of the study was planned to consist of a total of 132
patients, 33 patients in each group, taking into account possible data losses. By design, all
of the pre-test and post-test measurement tools will be applied to the first experimental and
control group, and only the post-test measurement tools will be applied to the second
experimental and control group. Randomization will be applied in determining the experimental
and control groups. The data will be collected using Personal Information Form (Appendix-1),
Infertility Stress Scale (ISS) (Appendix 2), Coping with the Infertility Stress Scale (CISS)
(Appendix-3), and Infertility Self-Efficacy Scale - Short Form (ISE-SF) (Appendix 4). The
preliminary application of the research will be completed with an average of 16 women, who
constitute at least 10% of the sample of 132 people. Research data will be collected in
approximately day 24 to 27 days for each patient from the initiation of Controlled Ovarian
Stimulation (COS) treatment to pregnancy determination of patients planned for intrauterine
insemination (IUI) treatment.
In the research, the experimental group will be given a brief face-to-face briefing about the
treatment process as well as a detailed training via the website. Web-based training is 60
minutes in total, including 4 modules. The web-based training content includes general
information about fertility, infertility diagnosis-treatment methods, drugs used in IUI
treatment and its application, and issues to be considered after IUI. The patients in the
control group, on the other hand, will be given the hospital's drug administration brochure
after brief face-to-face information and no other intervention will be made. When the
patients come back to the hospital for IUI treatment, they will fill out the Infertility
Stress Scale (ISS), Coping with the Infertility Stress Scale (CISS), Infertility
Self-Efficacy Scale - Short Form (ISE-SF). BHCG results of the patients will be learned on
the 14th day after IUI.