Protocol summary
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Study aim
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Comparison of mean health practice score in adolescent pregnant women in counseling and control groups
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Design
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Randomized controlled trial with two parallel arms
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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.
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Intervention groups
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The intervention group will receive 6 self-care counseling sessions and an educational booklet. The control group will only receive routine pregnancy care.
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Main outcome variables
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Mean score of health practices in adolescent pregnant
General information
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Reason for update
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because of pandemic situation of corona virus and closed dormitories, the study was needed to be done in home town of researcher.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20120718010324N54
Registration date:
2020-03-02, 1398/12/12
Registration timing:
prospective
Last update:
2021-04-29, 1400/02/09
Update count:
1
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Registration date
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2020-03-02, 1398/12/12
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2020-07-22, 1399/05/01
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Expected recruitment end date
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2021-01-09, 1399/10/20
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Actual recruitment start date
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2020-07-22, 1399/05/01
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Actual recruitment end date
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2021-01-27, 1399/11/08
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Trial completion date
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2021-02-18, 1399/11/30
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Scientific title
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The effect of self-care counseling on health practices of adolescent pregnant women: a randomized controlled trial
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Public title
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The effect of self-care counseling on health practices of adolescent pregnant women
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Purpose
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Supportive
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Inclusion/Exclusion criteria
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Inclusion criteria:
Residency in Bukan
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
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Age
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From 10 years old to 19 years old
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Gender
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Female
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Phase
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N/A
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Groups that have been masked
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No information
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Sample size
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Target sample size:
54
Actual sample size reached:
54
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2019-11-25, 1398/09/04
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Ethics committee reference number
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IR.TBZMED.REC.1398.913
Health conditions studied
1
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Description of health condition studied
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Health practices in adolescent pregnant women
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ICD-10 code
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ICD-10 code description
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Primary outcomes
1
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Description
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Health practices
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Timepoint
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Before the intervention and 4 weeks after the end of the intervention
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Method of measurement
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Health Practices Questionnaire-II
Secondary outcomes
1
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Description
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Attitudes towards motherhood and pregnancy
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Timepoint
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Before the intervention and 4 weeks after the end of the intervention
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Method of measurement
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Attitudes towards motherhood and pregnancy questionnaire
2
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Description
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Pregnancy symptoms
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Timepoint
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Before the intervention and 4 weeks after the end of the intervention
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Method of measurement
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Pregnancy Symptoms Scale
Intervention groups
1
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Description
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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.
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Category
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Behavior
2
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Description
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Control group: The control group will receive routine pregnancy care.
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Category
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N/A
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Tabriz University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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No - There is not a plan to make this available
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Justification/reason for indecision/not sharing IPD
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Data of participants are confidential.
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Study Protocol
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No - There is not a plan to make this available
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Statistical Analysis Plan
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Not applicable
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Informed Consent Form
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No - There is not a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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No - There is not a plan to make this available
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Data Dictionary
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No - There is not a plan to make this available
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Title and more details about the data/document
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The results of clinical study will be published as article.
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When the data will become available and for how long
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Immediately after publishing the results.
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To whom data/document is available
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All researchers
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Under which criteria data/document could be used
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Scientific using with citation to article
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From where data/document is obtainable
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Email: mirghafourvandm@tbzmed.ac.ir
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What processes are involved for a request to access data/document
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Maximum one week after the communication by email.
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Comments
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