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The effect of training through the application on improving the quality of life of infertile women

Protocol summary

Study aim
Investigating the effect of training through the application on improving the quality of life of infertile women
Design
This research is an experimental study - first by the quality of life of infertile women questionnaire-25 with 7 factors (psychological effects, sexual life with infertility, family and social effects, concerns related to infertility, physical effects, adaptive approaches, and factors preventing compromise) The quality of life is checked and if they get a score of 50% or less in each item, they will receive training related to the problem. The evaluation will be done one month and two months after the intervention, and the evaluations will be done with the same quality of life of infertile women questionnaire.
Settings and conduct
Sampling will be done by simple random sampling in Taleghani Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
Participants/Inclusion and exclusion criteria
Infertile women (one year after unprotected intercourse pregnancy has not occurred in them) No underlying disease No psychiatric disorders official contract Living with a spouse in the present No movement of grief in the last 6 months
Intervention groups
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 removing barriers to adaptation and addressing related concerns, the content of which is by reproductive health experts and the psychologist has been prepared and validated, installed and will be used by the research samples for two months. Then, in order to determine the effectiveness of the intervention, it will be completed twice, once after one month after use and again two months after use.
Main outcome variables
Quality of life of infertile women

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20120122008801N24
Registration date: 2022-07-24, 1401/05/02
Registration timing: prospective

Last update: 2022-07-24, 1401/05/02
Update count: 0
Registration date
2022-07-24, 1401/05/02
Registrant information
Name
Masoumeh Simbar
Name of organization / entity
Shahid Beheshti University for Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8820 2517
Email address
msimbar@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-02-19, 1401/11/30
Expected recruitment end date
2023-06-20, 1402/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of training through the application on improving the quality of life of infertile women
Public title
The effect of training through the application on improving the quality of life of infertile women
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
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
Exclusion criteria:
Lack of informed consent
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 100
Randomization (investigator's opinion)
Randomized
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.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committees of School of Pharmacy and Nursing & Midwifery- Shahid Beheshti University
Street address
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
City
Tehran
Province
Tehran
Postal code
۱۹۹۶۸۳۵۱۱۹
Approval date
2022-06-21, 1401/03/31
Ethics committee reference number
IR.SBMU.PHARMACY.REC.1401.063

Health conditions studied

1

Description of health condition studied
Infertility
ICD-10 code
N97
ICD-10 code description
Female infertility

Primary outcomes

1

Description
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

Secondary outcomes

empty

Intervention groups

1

Description
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.
Category
Other

2

Description
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.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Taleghani Hospital
Full name of responsible person
Masoumeh Simbar
Street address
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
City
Tehran
Province
Tehran
Postal code
۱۹۹۶۸۳۵۱۱۹
Phone
+98 21 8820 2512
Fax
+98 21 8865 5376
Email
msimbar@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Presidential Scientific and Technological Vice President
Full name of responsible person
Dr. Sorena Sattari
Street address
No. 20, Laden St., Sheikh Bahai North Street, Mollasadra Street, Vanak Square
City
Tehran
Province
Tehran
Postal code
1991745681
Phone
+98 21 8353 2371
Email
pr@isti.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Presidential Scientific and Technological Vice President
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Other

Person responsible for general inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Masoumeh Simbar
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
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
City
Tehran
Province
Tehran
Postal code
۱۹۹۶۸۳۵۱۱۹
Phone
+98 21 8820 2512
Email
msimbar@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Masoumeh Simbar
Position
Professor/ PhD of reproductive health
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
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
City
Tehran
Province
Tehran
Postal code
1996835119
Phone
+98 21 8820 2517
Fax
+98 21 8820 2517
Email
msimbar@sbmu.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Masoumeh Simbar
Position
Professor/ PhD of reproductive health
Latest degree
Ph.D.
Other areas of specialty/work
Street address
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
City
Tehran
Province
Tehran
Postal code
1996835119
Phone
+98 21 8820 2517
Fax
+98 21 8820 2517
Email
msimbar@sbmu.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data is potentially shareable after de-identifying individuals
When the data will become available and for how long
The access period starts 6 months after the results are published
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
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.
From where data/document is obtainable
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
What processes are involved for a request to access data/document
Request from the principal investigator, obtaining permission from Shahid Beheshti University of Medical Sciences
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