Determination of group supportive counseling on stress, anxiety, and health behaviors of pregnant women
Design
Randomized controlled clinical trial with two parallel groups
Settings and conduct
80 pregnant women with gestational age of 6 to 32 weeks referring to two comprehensive health center services of Babol city will be allocated randomly into two groups. The participants of group A (40 persons) will be receive combination of standard medical care of prenatal care and group for 6 weeks. The participants of group B (40 persons) receive only standard medical care of prenatal care. All participants will be filled four questionnaires including; Prenatal Distress Questionnaire(NuPDQ), State-Anxiety Inventory , Perceived Stress, and Health Behaviors Questionnaire, at the beginning of the study and the end of the study (6 weeks after beginning the study). Also, all participants will be taken salivary cortisol sample at the beginning of the study and the end of the study.
Participants/Inclusion and exclusion criteria
Inclusion criteria: gestational age between 6 to 32 weeks, level of education higher than primary school, informed consent. Exclusion criteria:severe intellectual disability, severe mental disorders
Intervention groups
Intervention group: Combination of standard medical care of prenatal care with supportive counselling. Control group: standard medical care
Main outcome variables
Stress of pregnancy, Anxiety, Health behavior
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20110228005931N7
Registration date:2018-10-09, 1397/07/17
Registration timing:registered_while_recruiting
Last update:2018-10-09, 1397/07/17
Update count:0
Registration date
2018-10-09, 1397/07/17
Registrant information
Name
Mahbobeh Faramarzi
Name of organization / entity
Babol University of medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 1329 4456
Email address
m.faramarzi@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-10-07, 1397/07/15
Expected recruitment end date
2019-01-20, 1397/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study the effect of group supportive counseling on stress, anxiety, and health behaviors of pregnant women
Public title
The effect of supportive counseling on stress of pregnant women
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 18 to 50 years
Gestational age between 6 to 32 weeks
Level of education higher than primary school
Informed consent
Exclusion criteria:
ُSevere Intellectual disability
Severe mental disorders
Age
From 18 years old to 50 years old
Gender
Female
Phase
0
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization method will be done by an independent statistician research team who allocates the participants to either the control or experimental group in equal probability 1:1, according to a computer-generated random numbers.
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
Ethic Committe of Babol University of Medical Sciences
Street address
Babol University of Medical Sciences, Ganjafroz Avenue, Babol, Mazandaran, Iran
City
Babol
Province
Mazandaran
Postal code
47176-47745
Approval date
2018-08-19, 1397/05/28
Ethics committee reference number
IR.MUBABOL.HRI.REC.1397.127
Health conditions studied
1
Description of health condition studied
Anxiety and stress of pregnancy
ICD-10 code
F41.3
ICD-10 code description
Other mixed anxiety disorder
Primary outcomes
1
Description
Stress of pregnancy
Timepoint
At beginning of the study and end of the study (6 weeks after beginning)
Method of measurement
Prenatal distress questionnaire (NUPDQ)
2
Description
Anxiety of pregnancy
Timepoint
At beginning of the study and end of the study (6 weeks after beginning)
Method of measurement
State Anxiety Inventory
3
Description
Health behaviors of pregnancy
Timepoint
At beginning of the study and end of the study (6 weeks after beginning)
Method of measurement
Prenatal Health behaviors Scale (PHBS)
Secondary outcomes
1
Description
General stress
Timepoint
At beginning of the study and end of the study (6 weeks after beginning)
Method of measurement
Salivary cortisol
2
Description
Perceived stress
Timepoint
At beginning of the study and end of the study (6 weeks after beginning)
Method of measurement
Perceived stress Questionnaire
Intervention groups
1
Description
Intervention group:The participants of this group will be receive combination of standard prenatal care with group counseling based on supportive therapy for six sessions120 minutes, once a week. Each group will be consisted of 8-12 participants. The group supportive therapy sessions will be constructed in a dynamic way to consider the health behaviors domains of pregnancy. Supportive counseling is a non-directive patient approach, except in the therapist’s pursuit of the patient’s affect. Common elements of supportive counseling are; make an emotional connection, follow affect, encourage catharsis, build the alliance, emphasize patient’s strengths (but not to avoid negative affect). A supportive therapist builds the therapeutic alliance with three core techniques including; allows the patient to set the course of treatment, listens carefully, and reflects back affect to the patient with careful clarifications.
Category
Behavior
2
Description
Control group: The participants of this group will be receive only standard prenatal care.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Comprehensive health service center of Ahangercola
Full name of responsible person
Maria Esfandyari
Street address
Babol- Ahangarcola village
City
Babol
Province
Mazandaran
Postal code
47176-47745
Phone
+98 11 3219 0597
Email
maryeikimm@gmail.com
2
Recruitment center
Name of recruitment center
Comprehensive health service center of Keshvari
Full name of responsible person
Maria Esfandyari
Street address
Babol- Golestan street
City
Babol
Province
Mazandaran
Postal code
47176-47745
Phone
+98 11 3219 0597
Email
maryeikimm@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Reza Ghadimi
Street address
Babol University of Medical Sciences, Ganjafroz Avenue, Babol, Mazandaran, Iran
City
Babol
Province
Mazandaran
Postal code
47176-47745
Phone
+98 11 3219 7667
Email
r.ghadimi@mubabol.ac.ir
Grant name
Master of thesis
Grant code / Reference number
4900
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Babol 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
Babol University of Medical Sciences
Full name of responsible person
Mahbobeh Faramarzi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Babol University of Medical Sciences, Ganjafroz Avenue, Babol, Mazandaran, Iran
City
Babol
Province
Mazandaran
Postal code
47176-47745
Phone
+98 11 1329 4456
Fax
+98 11 1329 4456
Email
mahbob330@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Mahbobeh Faramarzi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Babol- Babol University of Medical Sciences
City
Babol
Province
Mazandaran
Postal code
47158644247
Phone
+98 11 1329 4456
Fax
Email
m.faramarzi@mubabol.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Mahbobeh Faramarzi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Gang Afroz street-Babol University of Medical Sciences-Babol-Iran
City
Babol
Province
Mazandaran
Postal code
47176-47745
Phone
+98 11 1329 4456
Fax
+98 11 1329 4456
Email
m.faramarzi@mubabol.ac.ir
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