Comparison of mean health practice score in adolescent pregnant women in counseling and control groups
Design
Randomized controlled trial with two parallel arms
Settings and conduct
54 adolescent pregnant woman will be chosen from health centers of Tabriz city and will be allocated in two groups of counseling and control with bock randomization method. randomization will be conducted by person non involved in the sampling and data collection. The counseling group will receive 6 sessions of self care counseling in groups of 5 to 7 people. The questionnaires will be done before and 1 month after the intervention. Only data analyser will be blinded from the received intervention by groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Residency in Tabriz, Having a file in health centers (SIB system), Age between 10-19, Having at least a secondary or higher education, The desire to attend in counseling sessions, Gestational age 18-24 weeks Having a home and cell phone number
Exclusion criteria: High risk pregnancies including diabetes, high blood pressure and etc., Mental disorders or history of them or hospitalization because of them, Experiencing a terrible event in the past three months, Health conditions in which the pregnant woman should not have physical activity such as heart or pulmonary disease and etc.
Intervention groups
The intervention group will receive 6 self-care counseling sessions and an educational booklet. The control group will only receive routine pregnancy care.
Main outcome variables
Mean score of health practices in adolescent pregnant
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120718010324N54
Registration date:2020-03-02, 1398/12/12
Registration timing:registered_while_recruiting
Last update:2020-03-02, 1398/12/12
Update count:1
Registration date
2020-03-02, 1398/12/12
Registrant information
Name
Mojgan Mirghafourvand
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1479 6969
Email address
mirghafourvandm@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-01-20, 1398/10/30
Expected recruitment end date
2020-05-20, 1399/02/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of self-care counseling on health practices of adolescent pregnant women: a randomized controlled trial
Public title
The effect of self-care counseling on health practices of adolescent pregnant women
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Residency in Tabriz
Having a file in health centers (SIB system)
Age between 10-19
Having at least a secondary or higher education
The desire to attend in counseling sessions
Gestational age 18-24 weeks
Having a home and cell phone number
Exclusion criteria:
High risk pregnancies including diabetes, high blood pressure, chronic illnesses effecting on pregnancy such as cardiovascular or pulmonary diseases
Mental disorders or history of them or hospitalization because of them
Experiencing a terrible event that can effect on mental health in the past three months including death of a member of the family
Health conditions in which the pregnant woman should not have physical activity such as heart or pulmonary disease, cervical incompetence, high risk multiple pregnancy, continuous vaginal bleeding, placenta previa after 26 weeks of pregnancy and high blood pressure
Age
From 10 years old to 19 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
54
Randomization (investigator's opinion)
Randomized
Randomization description
Participants will be allocated to self-care counselling or control groups with an allocation ratio of 1:1. Randomization will be conducted using the website www.random.org and through block randomization method. The block sizes will be 4 and 6. Consecutively numbered opaque sealed envelopes will be used to conceal the allocation sequence. The sequence generation and the envelop preparation will be done by a person not involved in the participant recruitment, intervention implementation, or collection or analysis of data.
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
Ethics committee of Tabriz University of Medical Sciences
Street address
Faculty of Nursing Midwifery, South Shariati Street
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Approval date
2019-11-25, 1398/09/04
Ethics committee reference number
IR.TBZMED.REC.1398.913
Health conditions studied
1
Description of health condition studied
Health practices in adolescent pregnant women
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Health practices
Timepoint
Before the intervention and 4 weeks after the end of the intervention
Method of measurement
Health Practices Questionnaire-II
Secondary outcomes
1
Description
Attitudes towards motherhood and pregnancy
Timepoint
Before the intervention and 4 weeks after the end of the intervention
Method of measurement
Attitudes towards motherhood and pregnancy questionnaire
2
Description
Pregnancy symptoms
Timepoint
Before the intervention and 4 weeks after the end of the intervention
Method of measurement
Pregnancy Symptoms Scale
Intervention groups
1
Description
For intervention group, self-care counseling as six 60-90 minutes group sessions will be held in health centers of Tabriz by researcher from 25th week of pregnancy. The interval of sessions will be one week. The contents of counseling sessions will include providing information about pregnancy and childbirth, prenatal care, effect of adequate rest and sleep, appropriate physical activity, accurate diet, accurate health practices and their importance and benefits, signs and symptoms of pregnancy and training of necessary self-care behaviors to control of annoying symptoms.
Category
Behavior
2
Description
Control group: The control group will receive routine pregnancy care.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Health centers of Tabriz city
Full name of responsible person
Ronya Rezaie
Street address
Nursing and Midwifery faculty, South Shariati street
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3479 6969
Email
rorezaie08@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mohammad Samiei
Street address
Research department, third floor, central construction number 2, Tabriz University of Medical Sciences, Golgasht Street, Azadi Avenue, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3479 6969
Email
iro@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Ronya Rezaie
Position
M.Sc student of counseling in Midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Faculty of Nursing Midwifery, South Shariati Street
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 44 4622 3261
Email
rorezaie08@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mojgan Mirghafourvand
Position
PhD of Reproductive Health
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Faculty of Nursing Midwifery, South Shariati Street
City
Tabriz
Province
East Azarbaijan
Postal code
51745-347
Phone
+98 41 3479 6770
Fax
+98 41 3479 6969
Email
mirghafourvandm@tbzmed.ac.ir
Web page address
http://nursing.tbzmed.ac.ir/
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mojgan Mirghafourvand
Position
PhD of Reproductive Health
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Nursing & midwifery faculty, South Shariati Street
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3479 6770
Fax
+98 41 3479 6969
Email
Mirghafourvandm@tbzmed.ac.ir
Web page address
http://nursing.tbzmed.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Data of participants are confidential.
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
The results of clinical study will be published as article.
When the data will become available and for how long
Immediately after publishing the results.
To whom data/document is available
All researchers
Under which criteria data/document could be used
Scientific using with citation to article
From where data/document is obtainable
Email: mirghafourvandm@tbzmed.ac.ir
What processes are involved for a request to access data/document
Maximum one week after the communication by email.