Determining the effect of e-learning of prenatal care to husbands on self-care and perceived stress of nulliparous pregnant women
Design
Control group clinical trial with parallel groups, one-sided (researcher), block randomization, on 68 samples, the website https://www.Randomization.com was used for randomization of blocks
Settings and conduct
Regarding the effect of e-learning on prenatal care (supportive, counseling and empowerment) of pregnant women's spouses is primiparous on the health of their pregnant women. From the researcher, dark envelopes will be used at the time of sampling
Participants/Inclusion and exclusion criteria
Inclusion criteria for primiparous pregnant women who want to become pregnant and live with their husbands, and for inclusion criteria for wives, have access to a smartphone and have the ability to use it and both are satisfied to participate in the study.
Intervention groups
Intervention group: Wives of nulliparous pregnant women who receive prenatal care training electronically
Control group: Wives of nulliparous pregnant women who receive routine prenatal care training
Main outcome variables
self-care score of pregnant women, Perceived stress rate of pregnant women, Weight gain of pregnant women
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210315050718N1
Registration date:2021-04-25, 1400/02/05
Registration timing:registered_while_recruiting
Last update:2021-04-25, 1400/02/05
Update count:0
Registration date
2021-04-25, 1400/02/05
Registrant information
Name
fariba abbaszadeh nezam abad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6625 1327
Email address
fariba.abbaszadehnezamabad2017@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-03-21, 1400/01/01
Expected recruitment end date
2021-06-22, 1400/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of e-learning pregnancy care training for husbands on self-care and perceived stress in nulliparous pregnant women
Public title
The effect of e-learning pregnancy care training for husbands on self-care and perceived stress in nulliparous pregnant women
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Inclusion criteria for nulliparous pregnant women: Age between 18-45 years (reproductive ages) Have a minimum gestational age of 8 weeks (based on the first ultrasound performed or the first day of the last menstrual period) First pregnancy Single pregnancy Living with a spouse Inclusion criteria for wives of nulliparous women: Monogamy Smartphone access
Exclusion criteria:
Criteria for not including nulliparous pregnant women: Inability to read and write unwanted pregnancy Having a history of infertility Dissatisfaction with participating in the study Having symptoms threatening abortion (spotting, not hearing the sound of the fetal heart, back pain, etc.) Having a mental illness according to the individual's own expression Having a specific disease such as diabetes and ... Criteria for not including the wives of nulliparous women: Inability to read and write Dissatisfaction with participating in the study Having a mental illness according to the individual's own expression Lack of ability to use social networks
Age
From 18 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
68
Randomization (investigator's opinion)
Randomized
Randomization description
68 samples are selected by available sampling method and list of apple system of each center and are allocated in two groups of control and intervention using block random allocation method. Due to the sample size, 17 blocks of 4 are required for random block allocation. The intervention group will be displayed with A and the control group with B. Pregnant women 's husbands are placed in quadruple blocks with two AAs each for intervention and two BBs for control. Samples can be placed in blocks in 6 different ways as follows:
1-AABB 2-ABAB 3-ABBA 4-BABA 5-BBAA 6-BAAB Then we roll the dice, for example 4 comes, BABA rolls the dice again, for example 5 comes BBAA and ... we repeat so much and We roll the dice to complete 68 samples or use the website https://www.Randomization.com to determine the random sequence of blocks. In order to hide the random allocation from the researcher, a dark envelope sample size is prepared and each of the random sequences created is recorded on a card and placed inside the envelope, and finally the envelope lid is pasted. At the beginning of the registration of individuals, according to the order of arrival of the samples, one of the envelopes is opened in order and the assigned group of that sample is specified.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants: People in the control group also receive routine care at the health center, so they also receive training, and it is not the case that they do not receive any training, and in the intervention group, we teach them.
Thus, participants do not know which group (intervention or control) they are in.
Data Analyzer: Also does not know if this is the data of the intervention group or the control group that is analyzing its data
Placebo
Not used
Assignment
Parallel
Other design features
In this study, education is given to the wives of pregnant women and the health consequences of the wives of their nulliparous women are measured to show the extent to which training, support and empowerment of the wives of nulliparous pregnant women can affect the health of their pregnant women.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee in Research, School of Nursing and Midwifery, Rehabilitation, Tehran University of
Street address
Tohid Square, Dr. Mirkhani St. (Eastern Nusrat)
City
Tehran
Province
Tehran
Postal code
1419733171
Approval date
2021-02-20, 1399/12/02
Ethics committee reference number
IR.TUMS.FNM.REC.1399.222
Health conditions studied
1
Description of health condition studied
Perceived stress in nulliparous pregnant women, self-care in nulliparous pregnant women, weight gain in nulliparous pregnant women
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
self-care score
Timepoint
At the beginning of the study (before the intervention), 8 weeks after the intervention
Method of measurement
Momeni Pregnant Women Self-Care Questionnaire
2
Description
perceived stress score
Timepoint
At the beginning of the study (before the intervention), 8 weeks after the intervention
Method of measurement
Cohen Perceived Stress Questionnaire
Secondary outcomes
1
Description
Weight gain of pregnant women (the closer the weight gain in the apple system is to the balance line, the more desirable)
Timepoint
At the beginning of the study (before the intervention), 8 weeks after the intervention
Method of measurement
Calibrated with digital scales and comparing the weight of pregnant women with the optimal weighting line of pregnant women in the apple system
Intervention groups
1
Description
Intervention group: Wives of nulliparous pregnant women who receive prenatal care training electronically
Category
N/A
2
Description
Control group: Wives of nulliparous pregnant women receiving routine prenatal care training
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
All comprehensive health service centers in the south of Tehran
Full name of responsible person
Fariba Abbaszadehnezamabad
Street address
No. 5, Unit 2, 30 Jahangir Khani Alley, Sina Town, Khalij St., Fatah Highway, Tehran
City
Tehran
Province
Tehran
Postal code
1378635469
Phone
+98 21 6625 1327
Email
fariba.abbaszadehnezamabad2017@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Ali Sahraian
Street address
Keshavarz Boulevard, corner of Quds Street, Central University Organization, sixth floor, Vice Chancellor for Research and Technology
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3686
Email
vcr@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
50
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
Tehran University of Medical Sciences
Full name of responsible person
Fariba.Abbaszadehnezamabad
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 5, Unit 2, Jahangir Khani Alley, Sina Town, Khalij St., Fatah Highway, Fatah Highway, Tehran
City
Tehran
Province
Tehran
Postal code
1378635469
Phone
+98 21 6625 1327
Email
fariba.abbaszadehnezamabad2017@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Fariba Abbaszadehnezamabad
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 5, Unit 2, Jahangir Khani Alley, Sina Town, Khalij St., Fatah Highway, Fatah Highway, Tehran
City
Tehran
Province
Tehran
Postal code
1378635469
Phone
+98 21 6625 1327
Email
fariba.abbaszadehnezamabad2017@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Fariba Abbaszadehnezamabad
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 5, Unit 2, Jahangir Khani Alley, Sina Town, Khalij St., Fatah Highway, Fatah Highway, Tehran
City
Tehran
Province
Tehran
Postal code
1378635469
Phone
+98 21 6625 1327
Email
fariba.abbaszadehnezamabad2017@gmail.com
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
Only part of the data, such as information about its main and secondary consequences, can be shared.
When the data will become available and for how long
Start of access period one year after printing results
To whom data/document is available
It will be available to researchers working in academic and scientific institutions, and people in industry can also apply for it.
What processes are involved for a request to access data/document
The applicant must fully state the purpose of the study and how to cite and use the material. This request will be sent to the tutor. If the tutor approves, the study data will be provided to the person. This process lasts for 10 days and at the end, the applicant will be asked to Cite it correctly