Determining the effectiveness of mindfulness-based counseling on pregnancy concerns and anxiety in primi gravidarum.
Design
Two arm parallel group randomized trial by blocking method with 30 people in each group
Settings and conduct
Sampling by multi-stage quotas, from Comprehensive Health centers from one of the areas of Mashhad, 10 samples were randomly selected from the list of pregnant women of that center that meets the entering criteria, and by calling them, invited to the health center for further examination and consent.
Participants/Inclusion and exclusion criteria
being within 12 to 24 weeks of pregnancy, having a singleton pregnancy, lack of a present or a history of psychiatric illness or chronic diseases in pregnancy, lack of high risk pregnancy items, Non-use of psychiatric drugs in a recent year, Non-use of drugs and psychotropic substances,
Non-attendance at Yoga classes, Mindfulness and Mind Management in the past 6 months
Intervention groups
Women in the intervention group, in addition to receiving usual prenatal care, also participate in 8-12 people mindfulness-based counseling group.Women in the control group, only receive the usual prenatal care.
Main outcome variables
Anxiety and worry of pregnant mothers
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190206042641N1
Registration date:2019-07-03, 1398/04/12
Registration timing:registered_while_recruiting
Last update:2019-07-03, 1398/04/12
Update count:0
Registration date
2019-07-03, 1398/04/12
Registrant information
Name
Reyhaneh Abbasi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 23 3239 5054
Email address
abbasir911@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-05-29, 1398/03/08
Expected recruitment end date
2019-09-01, 1398/06/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating effectiveness of Mindfulness-based Counseling on Pregnancy Concerns and Anxiety
Public title
Evaluating effectiveness of Mindfulness-based Counseling on Pregnancy Concerns and Anxiety
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
being Iranian and Persian speaking
being satisfactory and interesting in participating in the research
being her first pregnancy
being within 12 and 24 weeks of pregnancy
being a singleton pregnancy.
getting 10 points of 6-item Kessler questionnaire at least
Exclusion criteria:
Having high risk pregnancy items
Suffering from any chronic illnesses during pregnancy
Participate in yoga classes, mindfulness and mind management in the last 6 months
Use of psychiatric drugs in a recent year
Use Drug and psychotropic substances
Having a history of psychiatric illness
Age
From 18 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization is done by blocking method to balance the number of specimens assigned to each of the studied groups. In this way, the size of the blocks can be constant or variable. In this research, we used blocks with 4 equal numbers. Unit of randomization is individual. Random Block Sequencing Website have been used for randomization. The random sequence of locking is given to a specific person outside the research team and each mother assigns to either intervention or control group according to the time of arrival and random sequence.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Sampling will be done from specific health centers of 3 poor, medium and high socioeconomic regions of Mashhad.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahrood University of Medical Sciences
Street address
Shahrood University of Medical Sciences, 7th of Tir square
City
Shahrood
Province
Semnan
Postal code
7394736147
Approval date
2019-05-08, 1398/02/18
Ethics committee reference number
IR.SHMU.REC.1398.011
Health conditions studied
1
Description of health condition studied
anxiety in pregnant women
ICD-10 code
F06.4
ICD-10 code description
Anxiety disorder due to known physiological condition
2
Description of health condition studied
worry in pregnant women
ICD-10 code
R45.82
ICD-10 code description
Worries
3
Description of health condition studied
Mindfulness-based counseling
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Anxiety Score of Pregnant Women in Wendenberg Pregnancy Anxiety Inventory
Timepoint
Completing Wendenberg Anxiety Inventory before, after and 1 month after intervention
Method of measurement
Pregnancy Related Anxiety Questionnaire (Wendenberg)
2
Description
Pregnant women's worry score by Prenatal Distress Questionnaire
Timepoint
Completing the Prenatal Distress Questionnaire before, after and 1 month after intervention
Method of measurement
Prenatal Distress Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Pregnant women with high anxiety score, will receive 6 mindfulness-based counseling sessions within 6 consecutive weeks. The number of participation in each groups is 8 to 12 people, and the duration of each session will be about 90 minutes. Each session has an educational purpose and the participation practice Mindfulness exercises during the session. Also, homework is recommended for women to practice Mindfulness in everyday life.
Category
Behavior
2
Description
Control group: Pregnant women with high anxiety score, attend Preparation for Labor classes regularly, and no additional intervention will be done for this group.After 6 weeks, intended questionnaires will be completed again by the women.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Center for Comprehensive Health Services
Full name of responsible person
Reyhaneh Abbasi
Street address
Sanabad St., Mashhad Town
City
Mashhad
Province
Razavi Khorasan
Postal code
9185684538
Phone
+98 51 3841 5001
Fax
+98 51 3859 7313
Email
abbasir911@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Mohammad Hasan Emamian
Street address
7th of Tir square, Shahrood Town
City
Shahrood
Province
Semnan
Postal code
3614773955
Phone
+98 23 3239 6714
Fax
+98 23 3239 4852
Email
emamian@shmu.ac.ir
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahroud 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
Shahroud University of Medical Sciences
Full name of responsible person
Reyhaneh Abbasi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Shahrood University of Medical Sciences, Haft e Tir Square
City
Shahrood
Province
Semnan
Postal code
7394736147
Phone
+98 23 3239 5054
Fax
Email
abbasir911@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Reyhaneh Abbasi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Shahrood University of Medical Sciences, Haft e Tir Square
City
Shahrood
Province
Semnan
Postal code
7394736147
Phone
+98 23 3239 5054
Fax
+98 23 3239 5009
Email
abbasir911@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Reyhaneh Abbasi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Shahrood University of Medical Sciences, Haft e Tir Square
City
Shahrood
Province
Semnan
Postal code
7394736147
Phone
+98 23 3239 5054
Fax
+98 23 3239 5009
Email
abbasir911@gmail.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