The effect of group counseling based on cognitive behavioral therapy on anxiety and constipation of pregnant women
Design
A clinical trial with a control group, with parallel groups, has been blinded and randomized
Settings and conduct
Group counseling is provided for samples at Takestan City Health Centers
Participants/Inclusion and exclusion criteria
Gestational age between 10 and 20 weeks
Single hook
Mother's age is between 18-35 years old
No psychological treatment in the last 6 months
Diagnosis of constipation and pregnancy anxiety according to the questionnaire
Earn score 119-68 in anxiety (moderate and severe anxiety) and score of 32-9 in constipation (moderate and severe constipation)
Non arrival:
Mental illness (self-reported)
History of irritable bowel syndrome and constipation before pregnancy (self-reported)
History of digestive diseases
History of intestinal surgery
The incidence of pregnancy complications in the current pregnancy (high risk pregnancy requiring motility and activity of the mother such as a stable placenta)
Having a history of infertility before pregnancy
Use of drugs that affect anxiety and constipation during pregnancy (such as laxatives, diuretics, opioid analgesia, antidepressants)
Intervention groups
The control group carries out routine midwifery care in the covered centers and the intervention group, in addition to routine midwifery care, will be offered in group counseling classes based on cognitive-behavioral therapy in 6 consecutive 90-minute counseling sessions for 5 groups of 6 on a weekly basis.
Main outcome variables
anxiety : constipation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181205041852N1
Registration date:2019-02-05, 1397/11/16
Registration timing:prospective
Last update:2019-02-05, 1397/11/16
Update count:0
Registration date
2019-02-05, 1397/11/16
Registrant information
Name
solmaz ghorbani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 28 3333 8034
Email address
s.ghorbani@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-04-04, 1398/01/15
Expected recruitment end date
2019-05-20, 1398/02/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of group counseling based on cognitive-behavioral therapy on anxiety and constipation among pregnant women
Public title
The effect of group counseling based on cognitive-behavioral therapy on anxiety and constipation among pregnant women
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Gestational age from 10 to 20 weeks
single hook
The age of the mother between the ages of 35 and 18.
No psychological treatment in the last 6 months
Diagnose constipation and pregnancy anxiety according to the questionnaire Earn score 119-68 in anxiety (moderate and severe anxiety) and score of 32-9 in constipation (moderate and severe constipation)
Exclusion criteria:
Mental illness (self-reported)
The history of irritable bowel syndrome and constipation before pregnancy (self-reported)
History of digestive diseases
history of intestinal surgery
Incidence of pregnancy complications in the current pregnancy (high risk pregnancy requiring motility and activity of the mother such as a stable placenta )
Have a history of infertility before pregnancy
Use of drugs that affect anxiety and constipation in pregnancy (such as laxatives, diuretics, opioid analgesia, antidepressants)
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:
30
Randomization (investigator's opinion)
Randomized
Randomization description
At first, the available sampling method was selected by selected health centers, then the samples were selected through simple random sampling or random numbers and divided by random allocation method into two groups of intervention and control.
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 Qazvin University of Medical Sciences
Street address
Bahonar Blvd.-Qazvin University of Medical Sciences
City
qazvin
Province
Qazvin
Postal code
43199-15315
Approval date
2018-12-31, 1397/10/10
Ethics committee reference number
IR.QUMS.REC.1397.267
Health conditions studied
1
Description of health condition studied
constipation
ICD-10 code
F06.4
ICD-10 code description
Anxiety disorder due to known physiological condition
Primary outcomes
1
Description
anxiety
Timepoint
At the beginning of the study, one month and two months after the end of the consultation
Method of measurement
questionnaire
2
Description
Constipation
Timepoint
At the beginning of the study, one month and two months after the end of the consultation
Method of measurement
questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Group counseling for cognitive-behavioral therapy that takes place in six sessions of 90 minutes.
Category
Treatment - Other
2
Description
Control group: The control group will receive just the usual care of the pregnancy at the comprehensive health centers, and no other work is done for them.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Qazvin University of Medical Sciences
Full name of responsible person
Solmaz Ghorbani
Street address
Qazvin - Shahid Bahonar Blvd. - Qazvin University of Medical Sciences
City
Qazvin
Province
Qazvin
Postal code
34199-15315
Phone
+98 28 3333 6001
Fax
+98 28 3335 5162
Email
info@qums.ac.ir
Web page address
http://www.qums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Dr. Amir Peymani
Street address
Qazvin - Shahid Bahonar Blvd. - Qazvin University of Medical Sciences
City
Qazvin
Province
Qazvin
Postal code
34199-15315
Phone
+98 28 3333 6001
Fax
+98 28 3335 5162
Email
info@qums.ac.ir
Web page address
http://www.qums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qazvin University of Medical Sciences
Proportion provided by this source
1
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
Qazvin University of Medical Sciences
Full name of responsible person
Solmaz Ghorbani
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Qazvin - Shahid Bahonar Blvd. - Qazvin University of Medical Sciences
City
Qazvin
Province
Qazvin
Postal code
34199-15315
Phone
+98 28 3333 6001
Fax
+98 28 3335 5162
Email
info@qums.ac.ir
Web page address
http://www.qums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Solmaz Ghorbani
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Qazvin - Shahid Bahonar Blvd. - Qazvin University of Medical Sciences
City
Qazvin
Province
Qazvin
Postal code
34199-15315
Phone
+98 28 3333 6001
Fax
+98 28 3335 5162
Email
info@qums.ac.ir
Web page address
http://www.qums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Solmaz Ghorbani
Position
Counseling Midwifery Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Bahonar St. - Qazvin University of Medical Sciences
City
Qazvin
Province
Qazvin
Postal code
34199-15315
Phone
+98 28 3333 8034
Fax
+98 28 3323 7268
Email
s.ghorbani@qums.ac.ir
Web page address
http://www.qums.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
Publish as an article
When the data will become available and for how long
Publish as an article
To whom data/document is available
Publish as an article
Under which criteria data/document could be used
Publish as an article
From where data/document is obtainable
Publish as an article
What processes are involved for a request to access data/document