This clinical trial is performed to determine the effectiveness of cognitive-behavioral stress management skills training on anxiety during pregnancy and maternal-fetal attachment. Inclusion criteria: age between 18 to 35 years old; first pregnancy; 14 to 28 weeks gestational age based on the date of the first day of the last menstrual period; moderate or severe anxiety based on Beck Anxiety Inventory; ability to read and write; low-risk pregnancy; no history of significant mental and physical chronic diseases such as diabetes, cardiovascular disease and depression; avoiding the use of chemical or herbal anti-anxiety drugs and sedatives. Exclusion criteria: not wanting to take part in training sessions; complication of pregnancy that resulted in the inability of the mother to participate in class; medication to reduce anxiety; specialized counseling psychology and absence more than 3 times in educational sessions. The study population included all pregnant women referred to clinic of Imam Khomeini hospital of Khomein city, Iran. Thirty pregnant women eligible will be randomly divided into two groups (Intervention and control). Stress management skills training classes, 10 sessions (2 sessions per week) for 90 minutes for intervention group to be held. Evaluation 2 weeks after the meetings by Beck Anxiety Inventory and kranly Mother - fetal attachment questionnaire.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015111124997N1
Registration date:2015-12-08, 1394/09/17
Registration timing:prospective
Last update:
Update count:0
Registration date
2015-12-08, 1394/09/17
Registrant information
Name
Mobina Poormohammadi
Name of organization / entity
Arak university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 4622 7723
Email address
m.pormohammadi@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Arak University of Medical Sciences
Expected recruitment start date
2016-01-20, 1394/10/30
Expected recruitment end date
2016-06-19, 1395/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of Cognitive-Behavioral Stress Management Intervention on Anxiety in pregnancy and Maternal-Fetal attachment
Public title
Effectiveness of Cognitive-Behavioral Stress Management Intervention on Anxiety in pregnancy and Maternal-Fetal attachment
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria: age between 18 to 35 years old; first pregnancy; 14 to 28 weeks gestational age based on the date of the first day of the last menstrual period; moderate or severe anxiety based on Beck Anxiety Inventory; ability to read and write; low-risk pregnancy; no history of significant mental and physical chronic diseases such as diabetes, cardiovascular disease and depression; avoiding the use of chemical or herbal anti-anxiety drugs and sedatives. Exclusion criteria: not wanting to take part in training sessions; complication of pregnancy that resulted in the inability of the mother to participate in class; medication to reduce anxiety; specialized counseling psychology and absence more than 3 times in educational sessions.
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
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
research center of arak university of medical sciences
Street address
Basij Square , on the campus of the University of Medical Sciences - Department of Education and Research
City
arak
Postal code
38481-7-6941
Approval date
2015-09-14, 1394/06/23
Ethics committee reference number
ir.arak.mu.rec.1394.177
Health conditions studied
1
Description of health condition studied
pregnancy
ICD-10 code
Z34
ICD-10 code description
Supervision of normal pregnancy
2
Description of health condition studied
Anxiety
ICD-10 code
F41.1
ICD-10 code description
Generalized anxiety disorder
3
Description of health condition studied
maternal - fetal attachment
ICD-10 code
P00
ICD-10 code description
Fetus and newborn affected by maternal conditions that may be unrelated to present pregnancy
Primary outcomes
1
Description
Anxiety
Timepoint
Before intervention , Two weeks after the end of intervention
Method of measurement
Beck Anxiety Inventory
2
Description
Maternal - fetal attachment
Timepoint
Before intervention , Two weeks after the end of intervention
Method of measurement
Kranly maternal - fetal Attachment Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group : cognitive- behavioral stress management skills training , 10 sessions , 2 times a week , every 90 minutes
Category
Behavior
2
Description
Control group : No action
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Clinic of Imam Khomeini Hospital
Full name of responsible person
Mobina Poormohammadi
Street address
City
Khomein
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Nafisa Seyedzadeh
Street address
Arak University of Medical Sciences, Basij square
City
Arak
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?