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Effect of mindfulness - based stress reduction” approach on anxiety level of pregnancy in one- child women in Sirjan , 2017

Protocol summary

Study aim
1.Evaluation of anxiety level of pregnancy in one-child women in control group 2. Evaluation of anxiety level of pregnancy in one-child women in intervention group 3. Comparison of anxiety of pregnancy in one-child women in control group with intervention group
Design
In this research, 100 one-child women were chosen and a code was allocated to each of them. Then, the women were randomly divided into control and intervention groups.
Settings and conduct
Sirjan was divided into four area and then four schools were chosen by clusteral randomize.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Women of childbearing age (18-35 years old) with a child (32), Iranian with spouse status, ability to complete a questionnaire and conversation in Farsi (36), having upper secondary education (35) Lack of history of known neuropsychiatric disorders, non-use of psychosocial drugs, substance abuse, lack of secondary infertility, lack of pregnancy during the course of the project, and lack of decision on pregnancy in the future. Exclusion criteria: Absence in more than three sessions in the group training process (35), making important psychological and emotional changes during the study, such as death, sudden financial problems, marital and divorce problems, drug addiction.
Intervention groups
For the experimental group, the intervention of mindfulness-based stress reduction, would be performed in group sessions in 8 sessions 2.5 hours, once a week. While there is no intervention for the control group during this period.
Main outcome variables
Anxiety caused by pregnancy; Fear of childbirth, fear of having a physical or mental disability child, fear of changing marital relationships, Fear of changes in mood and its consequences on the child, self-centered fears or fear of changes in the mother's personal life

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20171129037676N1
Registration date: 2017-12-18, 1396/09/27
Registration timing: retrospective

Last update: 2017-12-18, 1396/09/27
Update count: 0
Registration date
2017-12-18, 1396/09/27
Registrant information
Name
Parvin Salehinejad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3222 3876
Email address
p_salehinejad@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-10-17, 1396/07/25
Expected recruitment end date
2017-11-22, 1396/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of mindfulness - based stress reduction” approach on anxiety level of pregnancy in one- child women in Sirjan , 2017
Public title
mindfulness - based stress reduction” on anxiety level of pregnancy
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Women have a child 6 years of age or older Women in reproductive age (18 to 35 years old) Iranian and being married Earning a score of 18 or more in the Pregnancy Anxiety Questionnaire
Exclusion criteria:
Being pregnant Having a secondary infertility record Use of psychiatric drugs and substance abuse
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: 60
Randomization (investigator's opinion)
Randomized
Randomization description
divided in two groups by simple random sampling
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
Kerman University of Medical Sciences ethics committee
Street address
Kerman Medical Sciences, Haft-Bagh Highway, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7616913555
Approval date
2017-08-08, 1396/05/17
Ethics committee reference number
1396.1705

Health conditions studied

1

Description of health condition studied
Pregnancy Anxiety
ICD-10 code
F41.9
ICD-10 code description
Anxiety disorder, unspecified

Primary outcomes

1

Description
Anxiety score equal or greater than 18
Timepoint
before and after the intervention
Method of measurement
Pregnancy Anxiety Questionnaire

Secondary outcomes

1

Description
Noting
Timepoint
Noting
Method of measurement
Noting

Intervention groups

1

Description
Experimental group: the Mindfulness-Based Stress Reduction approach should be performed in a group of 8 sessions 2.5 hours, once a week.
Category
Behavior

2

Description
Control group: The control group does not receive any intervention.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
دبستانها
Full name of responsible person
پروین صالحی نژاد
Street address
No:13, 6 Alley, Khorsheed street
City
Kerman
Province
Kerman
Postal code
7619819945
Phone
+98 34 3222 3876
Email
p_salehinejad@kmu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Abbas Pardakhty
Street address
Research & Technology Department, Tahmasb-Abad Crossroad
City
Kerman
Province
Kerman
Postal code
7619813159
Phone
+98 34 3226 3855
Email
abpardakhty@kmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman 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
Kerman University of Medical Sciences
Full name of responsible person
Parvin Salehinejad
Position
َAssociate professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Biotechnology
Street address
NO:13, 6 Alley, Khorsheed Street
City
Kerman
Province
Kerman
Postal code
7619819945
Phone
+98 34 3222 3876
Email
p_salehinejad@kmu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Parvin Salehinejad
Position
َAssociate professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Biotechnology
Street address
No:13, 6 َAlley, Khorsheed Ave
City
Kerman
Province
Kerman
Postal code
7619819945
Phone
+98 34 3222 3876
Email
p_salehinejad@kmu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Parvin Salehinejad
Position
َAssociate professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Biotechnology
Street address
No:13, 6 َAlley, Khorsheed Ave
City
Kerman
Province
Kerman
Postal code
7619819945
Phone
+98 34 3222 3876
Email
p_salehinejad@kmu.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
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
All data will be shared after unidentifiable people
When the data will become available and for how long
Start the access period 3 months after printing the results
To whom data/document is available
People who interested
Under which criteria data/document could be used
No condition
From where data/document is obtainable
To correspondence
What processes are involved for a request to access data/document
Express clear request and after 2 weeks of receiving information by the applicant
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