Determining the effect of mindfulness-based counseling on pregnancy anxiety and delivery satisfaction in primiparous women
Design
A randomized controlled clinical trial with a parallel group design of 60 participants and without blindness
Settings and conduct
This study, which will be done in health centers and hospitals in Kermanshah, is not blinded one. Sixty people will be randomly assigned to the intervention group and the control group. At the beginning of the study, anxiety and satisfaction questionnaire will be provided to the patients. After the intervention, the anxiety and satisfaction questionnaire is again provided to the patients and the two groups will be compared.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Pregnant women with 14 to 24 weeks gestational age; primiparous; wanted pregnancy; without medical and obstetrics complications based on the medical records; singleton; Having literacy.
Exclusion criteria: having history of severe neuropsychiatric or psychiatric medications; Having history of addiction and use of psychoactive drugs; History of suicide or psychosis
Intervention groups
For the intervention group, eight group intervention sessions will be conducted by the researcher twice a week on Mindfulness counseling.The control group receive routine care.
Main outcome variables
Pregnancy Anxiety; delivery Satisfaction
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170305032900N3
Registration date:2019-02-24, 1397/12/05
Registration timing:registered_while_recruiting
Last update:2019-02-24, 1397/12/05
Update count:0
Registration date
2019-02-24, 1397/12/05
Registrant information
Name
Sousan Heydarpour
Name of organization / entity
Kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 3823 2679
Email address
sheydarpour@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-12-06, 1397/09/15
Expected recruitment end date
2019-06-05, 1398/03/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The study of the effect of mindfulness-based counseling on the pregnancy anxiety and delivery satisfaction in primiparous women
Public title
The study of the effect of mindfulness-based counseling on pregnancy anxiety and delivery satisfaction
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Pregnant women with14 to 24 weeks gestational age-primiparous- wanted pregnancy- singleton- literacy
Exclusion criteria:
Unwillingness to participate in the study- medical and obstetrics complications based on the medical records- history of severe neuro-psychiatric or psychiatric medications- history of addiction and use of psychoactive drugs- suicidal thoughts, history of suicide or psychosis
Age
No age limit
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
In this study simple randomization method was used to implement random assignment. In this way, 60 cards matched in appearance were prepared and on the 30 of cards the number or code of 1 was written that specifies the intervention group or mindfulness-based counseling and on the other 30 cards the number or code of 2 was written that identifies the control group means routine care. Then, each eligible person randomly selected one of these cards which the codes were written on it and in this way random allocation of groups was determined.
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 Kermanshah University of Medical Sciences
Street address
Shahid Beheshti Boulevard, Kermanshah
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Approval date
2018-11-19, 1397/08/28
Ethics committee reference number
IR.KUMS.REC.1397.606
Health conditions studied
1
Description of health condition studied
pregnancy anxiety
ICD-10 code
F41.1
ICD-10 code description
Generalized anxiety disorder
Primary outcomes
1
Description
Anxiety
Timepoint
before, immediately after and one month after intervention
Method of measurement
The Wendenberg Pregnancy anxiety Questionnaire has 17 items and five factors. The final score of this questionnaire is obtained by collecting the score of each statement. The score of each statement is ranged from one to seven; therefore, the pregnancy anxiety score can range from 17 to 119.
2
Description
Delivery satisfaction
Timepoint
24 hours after delivery
Method of measurement
Completing the Ganjir women's satisfaction questionnaire by participants
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: eight sessions of group mindfulness counseling twice a week by the researcher in addition to the routine care of clinics for pregnant women
Category
Prevention
2
Description
Control group: receive of routine care during pregnancy
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Health centers in Kermanshah and hospitals of Kermanshah city
Full name of responsible person
dr sousan heydarpour
Street address
میدان فردوسی
City
kermanshah
Province
Kermanshah
Postal code
6714415333
Phone
+98 83 3427 6301
Email
sheydarpou@kums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Farid Najafi
Street address
Shahid Beheshti Blvd., Building No. 2, Deputy Director of Research and Technology
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3835 4444
Email
sheydarpour@kums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Sousan Heydarpour
Position
Faculty Member of Kermanshah University of Medical Sciences
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Faculty Member of Kermanshah University of Medical Sciences
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3835 4444
Email
sheydarpour@kums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Sousan Heydarpour
Position
Faculty Member of Kermanshah University of Medical Sciences
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Faculty of Nursing and Midwifery, Dolatabad Blvd, Isar Square
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3828 2101
Fax
+98 83 3827 9394
Email
S.heydarpour1394@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Sousan Heydarpour
Position
Faculty Member of Kermanshah University of Medical Sciences
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Faculty of Nursing and Midwifery, Dolatabad Blvd, Isar Square
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3823 2679
Fax
+98 83 3827 9394
Email
S.heydarpour1394@yahoo.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