Protocol summary

Summary
The general goal of the study is determining the effect of Trans- theoretical model-based education on knowledge, attitude and decision making toward childbearing in reproductive age women who referring to community health centers in Amol city. The specific objectives of this plan are to determine and compare the attitudes, knowledge, decision-making balances, self-efficacy, and stages of behavior change towards childbearing in two groups, the test and control are before and after intervention. The type of this study was experimental, multi-stage sampling method and the selection of samples in each group was random and simple, and the number of samples was 76 in each group (152 in total) which are randomly selected from the two health centers of the urban community of Amol. Inclusion criteria are marriage; fertility; being healthy; aged 18 to 35, exclusion criteria are marital conflicts; Prohibition of childbearing. Training sessions are 5 one-hour sessions and various methods such as lecture with slideshow (with issues of importance and benefits of childbearing, healthy lifestyle before pregnancy, pre-conception counseling, etc.), video, question and answer, small group meetings. Primary outcomes are knowledge and attitude towards childbearing. Secondary outcomes are Structures such as stages of behavior change, self-efficacy and decision-making balance. Independent variable is Trans-theoretical model-based education. Dependent variables are attitude and knowledge about childbearing, self-efficacy, decision-making balance and the stages of behavior change.

General information

Acronym
-
IRCT registration information
IRCT registration number: IRCT2017083131117N4
Registration date: 2017-10-27, 1396/08/05
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-10-27, 1396/08/05
Registrant information
Name
Soghra Khani
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3336 8918
Email address
s.khani@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor for research, Mazandaran University of Medical Sciences
Expected recruitment start date
2017-10-07, 1396/07/15
Expected recruitment end date
2018-06-05, 1397/03/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Trans- theoretical model-based education on reproductive age women's knowledge, attitude and decision making toward childbearing
Public title
Effect of education on women's knowledge, attitude and decision making toward childbearing
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Marriage; living with husband; aged 18 to 35; fertility; having a maximum of 2 children; having passed at least one year of marriage; using a contraceptive method; interval between pregnancy more than 3 years; lack of planning for the current or future pregnancy despite the desire to have a child; access to the mobile phone; to be in pre-contemplation, contemplation and preparation groups based on trans-theoretical model. Exclusion criteria: absence in the first training session; unwillingness of woman or her husband to participate in a research project; infertility; severe family conflicts; more than 3 times cesarean section; certain chronic diseases and any prohibition of childbearing
Age
From 18 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 152
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
table of random number will be used.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
ٍEthics committee of Mazandaran University of Medical Sciences
Street address
vice chancellor for research, Mazandaran University of Medical Sciences, Moalem Square
City
Sari
Postal code
Approval date
2017-08-13, 1396/05/22
Ethics committee reference number
IR.MAZUMS.REC.1396.3112

Health conditions studied

1

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

Primary outcomes

1

Description
childbearing knowledge toward childbearing
Timepoint
Before the intervention, 3 and 6 months after the completion of the educational intervention
Method of measurement
validated Researcher-made questionnaire on childbearing

2

Description
childbearing attitude toward childbearing
Timepoint
before the intervention, 3 and 6 months after the intervention
Method of measurement
questionnaire

Secondary outcomes

1

Description
stages of behavior change construct
Timepoint
Before the intervention, 3 and 6 months after the completion of the educational intervention
Method of measurement
Decision-making questionnaire for childbearing based on a trans-theoretical model (Dr. Abolhassan Naghibi)

2

Description
self efficacy construct
Timepoint
before the intervention, 3 and 6 months after intervention
Method of measurement
decision making about childbearing questionnaire

3

Description
decision making about childbearing construct
Timepoint
before the intervention, 3 and 6 months after intervention
Method of measurement
decision making about childbearing questionnaire

Intervention groups

1

Description
The control group: This group will receive common education for promoting childbearing on the basis of new population policies in accordance with the Ministry of Health's instructions from the relevant center along with the intervention group.
Category
Behavior

2

Description
The intervention group: This group will receive training in accordance with their behavioral stages: 2 sessions of the precontemplation group (with topics: importance of childbearing in sociology, awareness of childbearing and the consequences of delay, discontinuation of contraceptive methods, healthy lifestyle before pregnancy), 2 sessions of the contemplation group (with topics: Interruption of contraceptive methods, healthy lifestyle, preconception counseling), and 1 session of the preparation group (with topics preconception counseling, embryo developmental stages, maternal health and discussion of teratogens, pregnancy symptoms and how to deal with it, importance of embryo screening during pregnancy, proper pregnancy care for childbearing), with various method such as lecture with slide show, question and answer, video, small group meetings. Each session will be 60 minutes long. At the end of each session a pamphlet summarizing its educational materials session will provide. After the completion of the training program, text messages will be provided on a weekly basis. In case of need, the test group can receive telephone or textual advice.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
two healthcare centers of Amol city
Full name of responsible person
Street address
City
Amol

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
vice chancellor for research of Mazandaran University of Medical Sciences
Full name of responsible person
Dr Enayati
Street address
Moalem squre, vice chansellor for research of Mazandaran University of Medical Sciences
City
Sari
Grant name
Grant code / Reference number
1396.3112
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
vice chancellor for research of Mazandaran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Mazandaran University of Medical Sciences, Sexual and Reproductive Health Research Center
Full name of responsible person
Dr Soghra Khani
Position
PhD, Moderator (owner) of project
Other areas of specialty/work
Street address
sexual and reproductive healthresearch center, Vesal street, Amir Mazandarani Boulevard
City
Sari
Postal code
Phone
+98 11 3335 8918
Fax
Email
s.khani@mazums.ac.ir, khanisog343@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr soghra Khani
Position
Modarator (owner) of [project/ PhD]
Other areas of specialty/work
Street address
sexual and reproductive healthresearch center, Vesal street, Amir Mazandarani Boulevard
City
Sari
Postal code
Phone
+98 11 3336 8918
Fax
Email
s.khani@mazums.ac.ir, khanisog343@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr Soghra Khani
Position
PhD/moderator (owner) of project
Other areas of specialty/work
Street address
sexual and reproductive healthresearch center, Vesal street, Amir Mazandarani Boulevard
City
Sari
Postal code
Phone
+98 11 3336 8918
Fax
Email
s.khani@mazums.ac.irkhanisog343@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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