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IRCT20120122008801N24 IRCT 2022-07-24 Presidential Scientific and Technological Vice President The effect of training through the application on improving the quality of life of infertile women The effect of training through the application on improving the quality of life of infertile women 2023-02-19 anticipated 100 Complete https://irct.ir/trial/64718 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: After obtaining informed consent and explaining the research objectives, all eligible women will be invited to the study and if they are willing and interested in participating in the study, they will be included in the research and will be randomly assigned to one of the control groups (n=50) and intervention (n=50) will be included. In this research, randomization into two groups will be done by the block randomization method. This way, 50 binary blocks will be considered in such a way that 25 blocks with order A and dimension B and another 25 blocks with order B and dimension A will be considered. Then, using the RAND() command in Excel software, 50 random numbers will be generated, and using these numbers, these 50 blocks will be sorted randomly. Then, the participants in the intervention group (A) and the control group (B) according to the order of visiting and in the order of A and B in each block. In this way, two groups of 50 people will be randomly assigned to intervention and control groups. N/A Infertility. Intervention 1: In the "intervention group", before the intervention, the demographic information questionnaire and the questionnaire for the quality of life of infertile women will be completed by the participants. For the "intervention group", the application for improving the quality of life of infertile women contains 57 educational clips of 5 to 25 minutes in 7 areas of improving physical, mental, sexual, family-social health, adaptation, and overcoming obstacles of the adaptation and also the related concerns. The content will be prepared and validated by the experts of reproductive health and psychologist and designed as an application. This application will e installed and used by the participants of the intervention group for one months. The application will be designed by the computer department of Tarbiat Modares University, Tehran, Iran. Then, in order to determine the effectiveness of the intervention, the questionnaire for the quality of life of infertile women will be completed twice, once one month after use and again two months later. Intervention 2: In the "control group", the participants will receive the routine education and counseling services of the clinic and will not install the application. The participants of the "control group" will also complete the demographic questionnaire and as well as the questionnaire for the quality of life of infertile women at the beginning of the study. in order to determine the effectiveness of the intervention, this group will also complete the questionnaire for the quality of life of infertile women twice, once after one month and once again after two months of routine interventions. The "control group" will receive the application for quality of life improvement after completing the study. In order to prevent the transfer of information between the intervention and control groups, the researcher will emphasize to the participants of the intervention group not to transfer information to the control group and reassure them about providing the content of the application to the "control group" after the completion of the study. Yes - There is a plan to make this available What will be shared: All data is potentially shareable after de-identifying individuals When: The access period starts 6 months after the results are published To whom: Researchers working in academic and scientific institutions Conditions: The data can be obtained by requesting from the main researcher and obtaining permission from Shahid Beheshti University of Medical Sciences with the confidentiality of the names of the individuals. Where to obtain: Dr. Masoumeh Simbar Midwifery and Reproductive Health Research Center, Shahid Beheshti University of Medical Sciences, Cross of Vali-Asr and Hashemi Rafsanjani Highway, Opposite to Rajaee Heart Hospital, Tehran, Iran Tel:۰۲۱۸۸۲۰۲۵۱۲ Postal Code: ۱۹۹۶۸۳۵۱۱۹ Fax: ۰۰۹۸۲۱ ۸۸۶۵۵۳۷۶ How to obtain: Request from the principal investigator, obtaining permission from Shahid Beheshti University of Medical Sciences Comments:
public Masoumeh Simbar
Midwifery and Reproductive Health Research Center, Shahid Beheshti University of Medical Sciences, Cross of Vali-Asr and Hashemi Rafsanjani Highway, Opposite to Rajaee Heart Hospital
Tehran Iran (Islamic Republic of) ۱۹۹۶۸۳۵۱۱۹ +98 21 8820 2512 msimbar@gmail.com Shahid Beheshti University of Medical Sciences scientific Dr. Masoumeh Simbar
Department of Reproductive Health and Midwifery, Faculty of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences (3th floor, Deputy of research), Vali-Asr Avenue, Cross of Vali-Asr and Neiaiesh Highway, Opposite to Rajaee Heart Hospital
Tehran Iran (Islamic Republic of) 1996835119 +98 21 8820 2517 msimbar@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Diagnosis of infertility with the opinion of a gynecologist Diagnosis of infertility with the opinion of a gynecologist official marriage No bereavement experience in the last 6 months no limit no limit Female Lack of informed consent N97 Female infertility Other Other In the "intervention group", before the intervention, the demographic information questionnaire and the questionnaire for the quality of life of infertile women will be completed by the participants. For the "intervention group", the application for improving the quality of life of infertile women contains 57 educational clips of 5 to 25 minutes in 7 areas of improving physical, mental, sexual, family-social health, adaptation, and overcoming obstacles of the adaptation and also the related concerns. The content will be prepared and validated by the experts of reproductive health and psychologist and designed as an application. This application will e installed and used by the participants of the intervention group for one months. The application will be designed by the computer department of Tarbiat Modares University, Tehran, Iran. Then, in order to determine the effectiveness of the intervention, the questionnaire for the quality of life of infertile women will be completed twice, once one month after use and again two months later. In the "control group", the participants will receive the routine education and counseling services of the clinic and will not install the application. The participants of the "control group" will also complete the demographic questionnaire and as well as the questionnaire for the quality of life of infertile women at the beginning of the study. in order to determine the effectiveness of the intervention, this group will also complete the questionnaire for the quality of life of infertile women twice, once after one month and once again after two months of routine interventions. The "control group" will receive the application for quality of life improvement after completing the study. In order to prevent the transfer of information between the intervention and control groups, the researcher will emphasize to the participants of the intervention group not to transfer information to the control group and reassure them about providing the content of the application to the "control group" after the completion of the study. Quality of life of infertile women. Timepoint: Measuring the quality of life of infertile women at the beginning of the study (before the start of the intervention), one month and two months after using the application. Method of measurement: Questionnaire of quality of life of infertile women. Presidential Scientific and Technological Vice President Approved 2022-06-21 Research Ethics Committees of School of Pharmacy and Nursing & Midwifery- Shahid Beheshti University Midwifery and Reproductive Health Research Center, Shahid Beheshti University of Medical Sciences, Cross of Vali-Asr and Hashemi Rafsanjani Highway, Opposite to Rajaee Heart Hospital, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)