The effectiveness of self-care counseling compared to usual pregnancy care on health behavior in pregnant women with unintended pregnancy: a randomized clinical trial
Determine the effect of self-care counseling on health behavior in pregnant women with unwanted pregnancy
Design
Clinical trial with intervention and control group, with parallel groups, phase 2 with a sample size of 188 people; The study is single blind because the evaluator of the outcomes will kept blind. The method of random allocation is block randomization with a block size of 6, which will be designed by the methodologist using Sealedenvelope.com.
Settings and conduct
The location of the study is the Perinatology Clinics of Rouhani and Yahya Nejad Hospitals in Babol. The study population is pregnant women who meet the inclusion criteria.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Unwanted pregnancy; singleton pregnancy; Age 18 to 40 years; gestational age 15 to 22 weeks; having atleast elementary literacy.
Exclusion criteria: medical disorders; Cognitive disorders; Presence of speech and hearing disorders; presence of pregnancy complications; use of drugs and alcohol; Reluctance to cooperate
Intervention groups
Intervention group: Six class sessions will be held once a week for this group. The duration of each class is 45 to 60 minutes. Based on the content of the self-care guidelines of the Ministry of Health, the relevant topics will be presented in the form of face-to-face counseling classes for the participants.The control group will receive the usual pregnancy care.
Main outcome variables
Health behavior in pregnant women with unintended pregnancy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160223026724N2
Registration date:2024-05-06, 1403/02/17
Registration timing:prospective
Last update:2024-05-06, 1403/02/17
Update count:0
Registration date
2024-05-06, 1403/02/17
Registrant information
Name
Shabnam Omidvar
Name of organization / entity
Babol University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 4422 2511
Email address
sh.omidvar@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-06-21, 1403/04/01
Expected recruitment end date
2025-03-19, 1403/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of self-care counseling compared to usual pregnancy care on health behavior in pregnant women with unintended pregnancy: a randomized clinical trial
Public title
The effect of self-care counseling on health behavior
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Unwanted pregnancy
Singleton pregnancy
18 to 40 years aged
Gestation age 15 to 22 weeks
having at least elementary literacy
Exclusion criteria:
Presence of medical disease (cardiovascular, kidney, cancer, etc.)
Presence of cognitive disorders
Presence of diseases or pregnancy complications (pre-eclampsia, gestational diabetes, gestational hypertension)
speech and hearing disorders that preventing communication with the researcher
Using drugs and alcohol
Unwillingness to cooperate
Age
From 18 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
188
Randomization (investigator's opinion)
Randomized
Randomization description
Our sample size is 188 people, which randomly divided into 94 people in the intervention group and 94 people in the control group in this study. The block random allocation method was designed by the methodologist using Sealedenvelop.com. The size of considered blocks is 6. The random assignment list will be available only to the first supervisor. In order to hide the random allocation process, the type of intervention (intervention or control group) is written on 188 paper cards and placed inside opaque paper envelopes. Only the first supervisor will be aware of the relevant code. The cards will be arranged in the box according to the randomization list. When the questioner (student/executive) declares the eligibility of the sample, the first supervisor will provide the paper envelope.
Blinding (investigator's opinion)
Single blinded
Blinding description
The person evaluating the outcomes will be a third party unaware of the random allocation process and the type of intervention performed.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Babol University of Medical Sciences
Street address
Babol University of Medical Sciences, Ganjafrooz Street
City
Babol
Province
Mazandaran
Postal code
4717647745
Approval date
2024-03-16, 1402/12/26
Ethics committee reference number
IR.MUBABOL.HRI.REC.1402.312
Health conditions studied
1
Description of health condition studied
Pregnancy Health behavior
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Health behavior score in pregnancy health behavior questionnaire in pregnant women with unwanted pregnancy
Timepoint
At the beginning of the study (before the start of the intervention) and one week after the end of the sessions
Method of measurement
Pregnancy Health Behavior Questionnaire (PHBS)
Secondary outcomes
1
Description
Maternal-fetal attachment
Timepoint
At the beginning of the study (before the start of the intervention) and one week after the end of the sessions
Method of measurement
Cranley Maternal-fetal attachment questionnaire
2
Description
Pregnancy distress
Timepoint
At the beginning of the study (before the start of the intervention) and one week after the end of the sessions
Method of measurement
Pregnancy distress questionnaire
Intervention groups
1
Description
Intervention group: self-care counseling in the form of educational classes of 45 to 60 minutes at an interval of one week for pregnant women with unwanted pregnancy. Relevant discussions will be held in the form of in-person counseling classes (six sessions once a week) based on the content of the self-care guidelines of the Ministry of Health. The content of the counseling sessions will be prepared and presented by the researcher in the form of conference, question and answer, PowerPoint, video and pamphlet.
Category
Behavior
2
Description
Control group: They will receive routine pregnancy care, and at the end of the study, a summary of the content of the sessions will be provided to the control group in the form of a booklet.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Rohani hospital
Full name of responsible person
Shabnam Omidvar
Street address
Rohani hospital; Ganjafrooz Street
City
Babol
Province
Mazandaran
Postal code
4717641367
Phone
+98 11 3223 8301
Fax
Email
Sh.omidvar@mubabol.ac.ir
2
Recruitment center
Name of recruitment center
Yahyanezhad hospital
Full name of responsible person
Mahdi Sepidarkish
Street address
Mostafa Khomeini street; Modarres avenue
City
Babol
Province
Mazandaran
Postal code
4713566547
Phone
+98 11 3223 5947
Fax
Email
Mahdi.sepidarkish@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Mahdi Rajabnia
Street address
Babol University of Medical Science; Ganjafroz avenue
City
Babol
Province
Mazandaran
Postal code
4717647745
Phone
+98 11 3219 9592
Email
info@mubabol.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Babol 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
Babol University of Medical Sciences
Full name of responsible person
Shabnam Omidvar
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Babol University of Medical Science; Ganjafroz avenue
City
Babol
Province
Mazandaran
Postal code
۴۷۱۷۶-۴۷۷۴۵
Phone
+98 11 3219 9592
Email
shomidvar@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Shabnam Omidvar
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Babol University of Medical Sciences; Ganjafroz avenue
City
Babol
Province
Mazandaran
Postal code
۴۷۱۷۶-۴۷۷۴۵
Phone
+98 11 3219 9592
Email
shomidvar@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Shabnam Omidvar
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Babol University of Medical Sciences; Ganjafroz avenue
City
Babol
Province
Mazandaran
Postal code
۴۷۱۷۶-۴۷۷۴۵
Phone
+98 11 3219 9592
Email
shomidvar@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