History
# Registration date Revision Id
2 2023-01-03, 1401/10/13 254154
1 2022-11-06, 1401/08/15 244959
Changes made to previous revision
This is the first revision

Protocol summary

Study aim
Evaluating the effect of Multimedia mental health selfcare program in infertile women based on cyberspace on users mental health
Design
A clinical trial with a control group, randomized on 90 patients (45 patients in intervention group and 45 patients in control group), was used to randomize the order (RAND) in Excel software.
Settings and conduct
Place of Research: Fatemeh Al-Zahra Infertility Training and Treatment Center, Babol city. Participants are placed in the intervention and control groups by easy and continuous sampling and random allocation. Before and after the intervention, both groups will complete the electronic questionnaires through the WhatsApp profile.
Participants/Inclusion and exclusion criteria
All infertile women eligible to enter the study, referred to Fatemeh Al-Zahra Infertility Center in Babol
Intervention groups
The intervention group is infertile women who refer to Fatemeh Al-Zahra Infertility Center in Babol city. In addition to receiving routine infertility care, they will have access to the content of their multimedia mental health care program through the link sent to WhatsApp. The control group is infertile women who refer to Fatemeh Al-Zahra Infertility Center in Babol, who will receive only routine infertility care.
Main outcome variables
Mental health (anxiety, depression, infertility-related stress, perceived stress, psychological well-being), satisfaction

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20210526051410N1
Registration date: 2022-11-06, 1401/08/15
Registration timing: prospective

Last update: 2022-11-06, 1401/08/15
Update count: 1
Registration date
2022-11-06, 1401/08/15
Registrant information
Name
FATEMEH YAHYAVI KOOCHAKSARAEI
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 4229 9150
Email address
fatemeh.yahyavi@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-12-22, 1401/10/01
Expected recruitment end date
2023-06-21, 1402/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the impact of a multi media mental health self-care program based on cyber Space on the mental health of infertile women
Public title
The impact of a multi media mental health self-care program based on cyber Space on the mental health of infertile women
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Having personal satisfaction Primary infertility diagnosed in the case Primary infertility diagnosed in first marriage In infertility treatment Age group 20 years and older Having an Android smartphone Installation of WhatsApp application or other Farsi messengers on mobile phone Adequate knowledge in the use of social networks (WhatsApp or other Farsi messengers ) Internet access Iranian nationality Infertility duration one year and above Being literate in reading and writing
Exclusion criteria:
History or current history of severe psychological disorders based on the participant's report such as major depression, bipolar depression and suicidal ideation Substance abuse or psychotropic drugs History of first-degree relatives dying or losing a job in the past 6 months Having an adopted child
Age
From 20 years old to 48 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 90
Randomization (investigator's opinion)
Randomized
Randomization description
In this research, randomization in two groups will be done by block randomization. In this way, 45 double blocks were considered as 23 blocks with order A and dimension B and another 22 blocks with order B and dimension A, then using the command (RAND) in Excel software, 45 random numbers were generated and with Using these numbers, these 45 blocks are arranged randomly. Then, individuals enter the intervention group (A) and the control group (B) based on the time of admission A and B in each block, respectively.
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
Babol St., Tlar Alley 14, Alpay building, first floor
City
ghaemshahr
Province
Mazandaran
Postal code
4765943961
Approval date
2021-04-27, 1400/02/07
Ethics committee reference number
IR.SBMU.PHARMACY.REC.1400.011

Health conditions studied

1

Description of health condition studied
Mental health
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Mental health of infertile women
Timepoint
Before and after the intervention
Method of measurement
Psychological Well-Being, Beck Depression, Spielberger Anxiety, Perceived Stress and Infertility Stress Questionnaires

Secondary outcomes

1

Description
Satisfaction with using a multimedia mental health self-care program
Timepoint
After the intervention
Method of measurement
Researcher-made questionnaire of satisfaction with education

Intervention groups

1

Description
Intervention group: Infertile women are referred to Fatemeh Al-Zahra Infertility Center in Babol. In addition to receiving routine infertility care, through the link sent to their WhatsApp personal page by the researcher to the content of the multimedia mental health self-care program uploaded on the Fatemeh Infertility Center website Al-Zahra will have access to the city of Babel and will use their mental health self-care behaviors for a specified period of time.
Category
Prevention

2

Description
Control group: Infertile women referred to Fatemeh Al-Zahra Infertility Center in Babol city will receive only routine infertility care during the intervention and are the same as the intervention group in terms of inclusion and exclusion criteria.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Fatemeh Al-Zahra Infertility Training and Treatment Center, Babol
Full name of responsible person
dr.s.e
Street address
Mazandaran, Babol
City
Babol
Province
Mazandaran
Postal code
0000000000000
Phone
+98 21 0000 0000
Fax
Email
fatemeh.yahyavi@yahoo.com
Web page address
https://www.mubabol.ac.ir/post/?id=16474

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
D
Street address
vali asr
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8865 5366
Email
sbnmf@sbmu.ac.ir
Web page address
http://nm.sbmu.ac.ir/index.jsp?fkeyid=&siteid=244&pageid=32447
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
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
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Fatemeh Yahyavi
Position
PhD Student
Latest degree
Master
Other areas of specialty/work
Reproductive Health
Street address
Babol St, Tlar Alley 14
City
GHaemshahr
Province
Mazandaran
Postal code
4765943961
Phone
0098 422299145
Email
Fatemeh.Yahyavi@Yahoo.Com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Fatemeh Yahyavi
Position
Phd Student
Latest degree
Master
Other areas of specialty/work
Reproductive Health
Street address
Babol St, Tlar Alley 14
City
Ghaemshahr
Province
Mazandaran
Postal code
4765943961
Phone
0098 42299145
Email
Fatemeh.Yahyavi@Yahoo.Com

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Fatemeh Yahyavi
Position
Phd Student
Latest degree
Master
Other areas of specialty/work
Reproductive Health
Street address
Babol St, Tlar Alley 14
City
Ghaemshahr
Province
Mazandaran
Postal code
4765943961
Phone
0098 42299145
Email
Fatemeh.Yahyavi@Yahoo.Com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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