The purpose of this study is to evaluate the effect of group counseling based on Mindfulness on pregnancy’s worries and stress.
Design
A trial with a control group, randomized allocation classified, and a sample size of 102 pregnant women.
Settings and conduct
At first, by using available sampling, samples are selected in all health centers of city of Gorgan.
Then, they are categorized by random allocation based on the score of the questionnaire into two groups of control and intervention.
The intervention group is invited to 8 weekly counseling sessions on Mindfulness, while the control group does not receive any counseling.
In the case of statistical analyzer, there is blindness and they do not know about the intervention and control of the codes.
Participants/Inclusion and exclusion criteria
Pregnant women with pregnancy’s worries and stresses with the first pregnancy and the gestational ages between 12 to 20 weeks.
Intervention groups
The experimental group will attended in 8 weeks group sessions on mindfulness based group counseling. Every session will last 120-150 minutes. The control group does not receive the sessions. Participants will complete the Pregnancy’s Worries and Stress Questionnaire before and after the end of the intervention.
Main outcome variables
Worries and stresses
General information
Reason for update
Acronym
MBCT= شناخت درمانی مبتنی بر ذهن آگاهی. MBSR= شناخت درمانی مبتنی بر کاهش استرس.
IRCT registration information
IRCT registration number:IRCT20171026037015N4
Registration date:2018-07-13, 1397/04/22
Registration timing:registered_while_recruiting
Last update:2018-07-13, 1397/04/22
Update count:0
Registration date
2018-07-13, 1397/04/22
Registrant information
Name
Houri Alijani
Name of organization / entity
Golestan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 17 3243 0360
Email address
alijani@goums.ac.ir
Recruitment status
Recruitment complete
Funding source
Golestan University of Medical Sciences, Faculty of Nursing, Midwifery of Boyeh
Expected recruitment start date
2017-11-18, 1396/08/27
Expected recruitment end date
2018-09-18, 1397/06/27
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of effect of group counseling based on Mindfulness on pregnancy’s worries and stress in nulliparous pregnant women
Public title
Evaluation of effect of group counseling based on Mindfulness on pregnancy’s worries and stress
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Pregnant nulliparous women
Aged 18 to 35 years old
Gestational age 12 to 20 weeks
The desire to participate in the study
The Pregnancy's Worries and Stress Questionnaire Score higher than 10
A low risk pregnancy
Exclusion criteria:
Having a degree of university education in medical sciences, psychology or counseling courses.
Severe family disputes in the week leading up to the study
Woman or her husband with a known psychological illness, Use of psychiatric medications or physical illnesses (such as cancers) and chronic illnesses during the past two months
Drug, psychotropic or alcohol abuse of woman or his husband in the past two months
Experience of formal mental health treatment before
Experience of severe stressful events during the past 3 months (a car crash or death of one of first grad relatives)
Age
From 18 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
Data analyser
Sample size
Target sample size:
102
Randomization (investigator's opinion)
Randomized
Randomization description
It has been randomized by using the minimization method, which is an non-randomized method in allocating samples to groups and it is based on scores of the questionnaires.
In this way, each of the two scores close to each other choose randomly based on throwing a coin in an intervention or control group. we will have two groups of 12 people in every steps for control and intervention groups.
This action continues to reach the sample of 51 people in each group.
Blinding (investigator's opinion)
Single blinded
Blinding description
The statistical analyzer is not informed about intervention and control groups.
Placebo
Not used
Assignment
Parallel
Other design features
-
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Golestan University of Medical Sciences
Street address
Hirkan Blvd, The Shast kola Ave, Deputy of Research and Technology, Golestan University of Medical Sciences, Gorgan Town
City
Gorgan
Province
Golestan
Postal code
4934174515
Approval date
2017-09-19, 1396/06/28
Ethics committee reference number
IR.GOUMS.REC.1396.141
Health conditions studied
1
Description of health condition studied
pregnancy's stress and worries
ICD-10 code
F41.9
ICD-10 code description
Anxiety disorder, unspecified
Primary outcomes
1
Description
Pregnancy's worries and Stresses score
Timepoint
Pregnancy Worries Score Measurement before the beginning of the first Mindfulness Consultation session and immediately after the last session.
Method of measurement
pregnancy's Stresses and Worries Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
The intervention group will receive Mindfulness based group counseling at 8 weekly sessions of 120-150 minutes, which will be held in groups of 6 to 12 people. By participating in Mindfulness counseling sessions, subjects will be able to relinquish their thoughts and control their thoughts through formal and informal practices of Mindfulness. They will learn the way of living in the body and the environment (instead of life in mind), which ultimately reduces the number of thoughts and the severity of their beliefs in them and creates mental relaxation.
Category
Behavior
2
Description
Control group: No intervention received
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Health Centers of the city of Gorgan
Full name of responsible person
Fateme Ebrahimi
Street address
Kalantari 13, Shahid Rajaee Ave, Gorgan Health Center, Gorgan Town
City
Gorgan
Province
Golestan
Postal code
4919689631
Phone
+98 17 3242 0710
Fax
+98 17 3242 9645
Email
ebrahimi1059@yahoo.com
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Dr. Mohammad Reza Honarvar
Street address
Shast kola Ave., Hirkan Blvd., Deputy of research and technology., Golestan University of Medical Sciences., Gorgan Town
City
Gorgan
Province
Golestan
Postal code
4915767446
Phone
+98 17 3245 1354
Fax
Email
erahimi1059@yahoo.com
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Gorgan 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
Gorgan University of Medical Sciences
Full name of responsible person
fateme ebrahimi
Position
Master's student in midwifery counseling
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Reproductive health and midwifery counsultant cometee- second floor- faculty of nursing and midwifery- falsafi complex- Golestan university of medical sciences- Shast kola Ave, Hirkan Blvd
City
Gorgan
Province
Golestan
Postal code
4934174515
Phone
+98 17 3242 1660
Fax
+98 17 3242 1657
Email
ebrahimi1059@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Dr Asie sadat Baniaghil
Position
Professor Assistant and Faculty Member of Golestan University of Medical Sciences
Latest degree
Ph.D.
Other areas of specialty/work
Health Service Management
Street address
Shast kola Ave, Hirkan Blvd, Faculty of Nursing Midwifery, Golestan University of Medical Sciences, Gorgan Town
City
Gorgan
Province
Golestan
Postal code
4913815739
Phone
+98 17 3245 6900
Fax
+98 17 3242 5171
Email
a-baniaghil@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Fateme Ebrahimi
Position
Master's student in midwifery counseling
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Shast kola Ave, Hirkan Blvd, Faculty of Nursing Midwifery, Golestan University of Medical Sciences, Gorgan Town
City
Gorgan
Province
Golestan
Postal code
4934174515
Phone
+98 17 3242 1660
Fax
+98 17 3242 1657
Email
Ebrahimi1059@yahoo.com
Web page address
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
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
Information on the main outcome or the like can be shared.
When the data will become available and for how long
Start the access period 6 months after printing the results
To whom data/document is available
Data will be available to researchers working in academic and academic institutions.
Under which criteria data/document could be used
The data will be available for scientific research with reference to the research. In order to access the data, they can reply to the person's e-mail address.
From where data/document is obtainable
En responsible person's email address: Ebrahimi@yahoo.com
What processes are involved for a request to access data/document
Applicants can respond to the email of the respondent and receive a response within a week.