Study of the effect of consultation based on the Pregnant mothers mind consciousness on Anxiety and Self-Efficacy In compliance with childbirth in Pregnant Women
determination of the effect of consultation Based on Self- Mindfulness on Anxiety and Self-Efficacy in Coping with Child Birth in Pregnant Women
Design
This Clinical practice has two groups: control group and, intervention group that participants are divided by using random numbers table in two groups of 36.
Settings and conduct
The selected Abyic County Centers, which include 5 comprehensive health services centers.
Participants/Inclusion and exclusion criteria
Exclusion :Iranian-Fluent in Persian-first pregnancy-planned pregnancy
gestational age of 28-34 weeks-single pregnancy-in the absence of known disease or psychological problems
Inclusion criteria:Non-participation in 2 Full Sessions of Counseling for Known MedicalConditions-Psychosocial Problems-Abortion History
Intrauterine Death-Maternity Company in Childbirth Classes
Occurrence of Preterm Delivery-Participants in Yoga classes, Relaxation
Intervention groups
In the intervention group, pregnant women with entry criteria are referred to the selected centers in Abik, who will receive weekly counseling during 5 sessions (90 minutes)
Main outcome variables
Anxiety- Self-efficacy in childbirth adaptation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150119020719N9
Registration date:2018-05-29, 1397/03/08
Registration timing:retrospective
Last update:2018-05-29, 1397/03/08
Update count:0
Registration date
2018-05-29, 1397/03/08
Registrant information
Name
Sara Esmaelzadeh Saeieh
Name of organization / entity
Alborz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 26 3433 6007
Email address
s-esmaelzadeh@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-02-19, 1396/11/30
Expected recruitment end date
2018-05-18, 1397/02/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of the effect of consultation based on the Pregnant mothers mind consciousness on Anxiety and Self-Efficacy In compliance with childbirth in Pregnant Women
Public title
The effect of counseling on Anxiety and Self-Efficacy in Coping with Child Birth in Pregnant Women
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Iranian
Fluent in Persian
first pregnancy
planned pregnancy
gestational age of 28-34 weeks
single pregnancy
in the absence of known disease or psychological problems
Exclusion criteria:
Non-participation in 2 Full Sessions of Counseling for Known Medical Conditions
Psychosocial Problems
Abortion History
Intrauterine Death
Maternity Company in Childbirth Classes
Occurrence of Preterm Delivery
Participants in Yoga classes, Relaxation
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
72
Randomization (investigator's opinion)
Randomized
Randomization description
Use the random numbers table
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 Alborz University of Medical Sciences
Street address
Vice-Chancellor for Research and Technology,Alborz University of Medical Sciences,above Taleghani Square,Taleghani Square,karaj,alborz,Iranlborz, Iran
City
karaj
Province
Alborz
Postal code
3149779453
Approval date
2017-12-22, 1396/10/01
Ethics committee reference number
Abzums.Rec.1396.152
Health conditions studied
1
Description of health condition studied
anxiety
ICD-10 code
F06.4
ICD-10 code description
Anxiety disorder due to known physiological condition
Primary outcomes
1
Description
consultation Based on self- mindfulness
Timepoint
Before the intervention, After the intervention, two week after the intervention
Method of measurement
Freiburg Mindfulness Questionnaire
2
Description
Anxiety
Timepoint
Before the intervention, After the intervention, two week after the intervention
Method of measurement
Pregnancy Related Anxiety Questionnaire
3
Description
self-efficacy in coping with child birth
Timepoint
Before the intervention, After the intervention, two week after the intervention
Method of measurement
self-efficacy in coping with child birth questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Consultation on reducing the amount of stress based on mindfulness. Holding 6 training sessions of 60 minutes. The sessions are as follows: Session 1: Research objectives, Mindfulness definition, Self-efficacy definition, Anxiety definition. Session 2: An explanation of the process of delivery, Maternal pain, ways to reduce labor pain, and review the techniques of mindfulness, consciousness in sitting, relaxed sleep, third session: Expression of mothers' experiences, strategies for reducing their anxiety, reviewing techniques, conscious breathing in sitting position, relaxing tone And relaxation, fourth session: teaching relaxation and explaining the activity of the home Fifth: Examination of homework, training on respiratory control training and respiratory meditation. Session Six: Review assignments, review previous sessions
Category
Behavior
2
Description
Control group receives during pregnancy routine care included pregnancy examination, fetal heart rate and all of recommended program in ministry of health and medical education guideline (after the end of consulting session in interventional group to observe ethics research booklet, containing advice, will be provided to the control group).
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Abyek Health Center
Full name of responsible person
Masomeh Zarenejad
Street address
Abyek District Health Center, Abbasi Municipality, FoundationTaleghani Street , Abyk , Qazvin
City
Abyek
Province
Qazvin
Postal code
34419-14441
Phone
+98 28 3282 7731
Fax
+98 28 3289 2557
Email
m13zare64@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research Assistant Alborz University of Medical Sciences
Full name of responsible person
Mohammad Noori Sepehr
Street address
Azymyh Square - Research Assistant Alborz University of Medical Sciences
City
Alborz
Province
Alborz
Postal code
0098
Phone
+98 26 3255 8920
Email
m13zare64@gmail.com
Grant name
Alorz University of Medical Sciences-vice President of Research
Grant code / Reference number
خالی
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Assistant Alborz 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
Research Assistant Alborz University of Medical Sciences
Full name of responsible person
Sara Esmaelzadeh Saeieh
Position
faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
School of Nursing and Midwifery,first Golestan,Alborz
City
Alborz
Province
Alborz
Postal code
0098
Phone
+98 912 623 2569
Email
esmaelzadeh1360@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Alborz University of medical sciences
Full name of responsible person
Sara Esmaelzadeh Saeieh
Position
Faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Alborz University of medical sciences -school of nursing and midwifery- first Golestan-Baghestan
City
Karaj
Province
Alborz
Postal code
0098
Phone
+98 26 3433 6007
Fax
+98 26 3433 6007
Email
esmaelzadeh1360@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Alborz University of medical sciences
Full name of responsible person
Sara Esmaelzadeh Saeieh
Position
Faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Alborz University of medical sciences -school of nursing and midwifery- first Golestan-Baghestan
City
Alborz
Province
Alborz
Postal code
0098
Phone
+98 26 3433 6007
Fax
+98 26 3433 6007
Email
s-esmaelzadeh@razi.tums.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
All participants data can be shared after being unidentified
When the data will become available and for how long
Start the access period after publishing the results