Determining the effect of postnatal consciousness on prenatal women with normal delivery in Yasuj city
Design
An interventional study is a clinical trial that will be carried out on 90 pregnant women at the entrance to the study, referring to health centers and Imam Sajjad Educational Hospital. Participants will be assigned into two groups using block randomization.
Settings and conduct
The group is divided into three groups of 15 in one of the "Saturday", "Monday" or "Wednesday" time groups.During the eight sessions, the researcher will intervene at the conference hall of the Imam Sajjad Hospital in accordance with the guidebook "Mindfulness-based cognitive therapy for depression" in each of these days.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Normal delivery;Primipara women; 18-35 years old;Pregnancy age 30-33 weeks;Literate;Inhabitant of Yasuj City;Iranian,Wanted pregnancy; single fetus,The lack of severe pregnancy complications;The lack of high risk pregnancies;Having mental health;The desire to participate in the study
Exit criteria include:
Mother's dissatisfaction; immigration;Mother's Fatigue ;Severe complications of pregnancy ;Severe complications during and after childbirth
Intervention groups
There will be no intervention in the control group.The researcher will present the executive and content schedules contained in the protocol in eight sessions of the two-hour week for the subject group.They will all be intercepted by a single person, with the same content and methodology, based on the guidebook "Mindfulness-based cognitive therapy for depression.
Main outcome variables
Postpartum blues
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170613034511N2
Registration date:2018-07-02, 1397/04/11
Registration timing:prospective
Last update:2018-07-02, 1397/04/11
Update count:0
Registration date
2018-07-02, 1397/04/11
Registrant information
Name
Fatemeh Karami mahmoodabad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 74 3333 6872
Email address
fatemeh.karami@yums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-07-06, 1397/04/15
Expected recruitment end date
2018-09-06, 1397/06/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of mindfulness on postpartum blues of primiparous women with normal delivery
Public title
The impact of mindfulness on postpartum blues.
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Primipara women
18-35 Years old
Literate (at least read and write)
Inhabitant of Yasuj City
Iranian
Wanted pregnancy
To have single fetus
Lack of severe pregnancy complications
Lack of high risk pregnancy
Having a mental health
Lack of depression
The desire to participate in the study
Exclusion criteria:
Dissatisfaction of mother
Mother's immigration
Lack of motivation to participate in the study
Having severe pregnancy complications
High-risk pregnancy
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:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Participants will be assigned into one of two groups using block randomization.
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 Yasuj University of Medical Sciences
Street address
No.1, Reyhan 1 Ave., Mahmoodabad
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591958435
Approval date
2017-08-05, 1396/05/14
Ethics committee reference number
IR.YUMS.REC.1396.86
Health conditions studied
1
Description of health condition studied
Postpartum blues
ICD-10 code
O99.3
ICD-10 code description
Mental disorders and diseases of the nervous system complicating pregnancy, childbirth and the puerperium
Primary outcomes
1
Description
Postpartum blues
Timepoint
Measure the blues after the day in the third, seventh and Tenth days after the delivery
Method of measurement
Steinُs Maternity Blues Scale
Secondary outcomes
1
Description
Mindfulness score
Timepoint
Before and after the beginning of the intervention
Method of measurement
Five Point Questionnaire of Mindfulness
Intervention groups
1
Description
Intervention group:After identifying the subjects in the group, the researcher implemented the executive and content protocols in the eight sessions of the two-weekly weekly, based on the book "Mindfulness-based cognitive therapy for depression.The topics of the first to fourth sessions: 1-Explaining the importance of being present at the moment of being and being here and now, and opening the concept of mindfulness to members using a variety of techniques, and learning to do everyday things, along with their attention2-Getting to the minds of wandering and practicing attention to the body, physical and physical sensation, and attention to breathing3-Relax the wandering mind by practicing breathing and brainstorming, sitting meditations and doing exercises that bring attention to the moment4-.Learning to stay at the moment in a moment without escaping and avoiding people, and watching the turmoil of thoughtsThe subject of the fifth to eighth sessions:1-A full knowledge of thoughts and feelings and their acceptance of judgment and direct involvement2-Changing mood and thoughts through the perception of thought as just thought and not reality3-Being aware of the sad signs and adjusting the program for a possible encounter with sad signs4-Planning for the future and using the presence techniques to continue their lives and generalize them to the whole life cycle.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Sajad hospital
Full name of responsible person
Karami Mahmoodabad Fatemeh
Street address
NO.1, Reyhan1 Ave., Mahmoodabad
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591958435
Phone
+98 74 3322 7606
Email
fatemeh.karami@yums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Dr Zoladl Mohammad
Street address
Motahari Blvd, University of Medical Sciences
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591741417
Phone
+98 74 3333 7230
Email
zoladl@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yasouj 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
Yasouj University of Medical Sciences
Full name of responsible person
Karami Mahmoodabad Fatemeh
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No.1, Reyhan 1 Ave., Mahmoodabad
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591958435
Phone
+98 74 3322 7606
Email
fatemeh.karami@yums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Karami Mahmoodabad Fatemeh
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No.1, Reyhan 1Ave., Mahmoodabad
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591958435
Phone
+98 74 3322 7606
Email
fatemeh.karami@yums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Karami Mahmoodabad Fatemeh
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No.1, Reyhan1 Ave., Mahmoodabad
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591958435
Phone
+98 74 3322 7606
Email
fatemeh.karami@yums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
There is a possibility to share some of the data, such as information about the message.
When the data will become available and for how long
Available 6 months after the results are printed.
To whom data/document is available
The research data will be available to researchers working in academic and academic institutions.
Under which criteria data/document could be used
Use of data and documentation to conduct more research and access to more complete results
From where data/document is obtainable
You can use e-mail to receive data from the Homestay.
What processes are involved for a request to access data/document
Requests for data and documentation are sent by email.As soon as possible, access to the requested files is available