This study aimed to compare the effect of group counseling, cognitive therapy, speech interactive approach anxiety nulliparous women during pregnancy has been implemented. The population studied in this research project, nulliparous pregnant women with backgrounds in health care centers since the late 1393's and early 1394's periodic pregnancy have . The sample size in this study 91 patients, who were randomly assigned to three groups: group counseling, interactive lecture and control group . In group counseling, participants in 4 sessions of cognitive therapy group . The interactive lectures were also participants in the 4 sessions. The control group in this study received only usual care. Inclusion criteria for this study were: nulliparous pregnant women ; gestational age between 13 and 28 weeks ; non-smoking ; hookah and drugs ; the lack of medical and mental illness ; the mother would like to participate in this plan. Exclusion criteria in the study were: the mother's unwillingness to continue the work ; creating the danger signs in pregnancy such as: bleeding, discharge, abortion. In this study ,The state anxiety, trait entire Spielberger anxiety questionnaire at baseline prior to intervention, and 4 weeks after treatment was measured.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015071022609N1
Registration date:2015-07-10, 1394/04/19
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-07-10, 1394/04/19
Registrant information
Name
Zohre Shahhosseini
Name of organization / entity
Mazandaran Univercity of Medical Science, Nasibe School Of Nursing and Midwifery
Country
Iran (Islamic Republic of)
Phone
+98 11 3336 7342
Email address
z.shahhosseini@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mazandaran Univercity Of Medical Science
Expected recruitment start date
2015-03-11, 1393/12/20
Expected recruitment end date
2015-05-10, 1394/02/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of effect of group counseling (Cognitive Therapy) and Interaction lecture on Anxiety During Pregnancy in Primiparas
Public title
Comparison of Effect of group counseling (Cognitive Therapy) and Interaction lecture on Anxiety During Pregnancy in Primiparas
Purpose
Treatment
Inclusion/Exclusion criteria
. Inclusion criteria for this study were: nulliparous pregnant women ; gestational age between 13 and 28 weeks ; non-smoking ; hookah and drugs ; the lack of medical and mental illness ; the mother would like to participate in this plan.
Exclusion criteria in the study were: the mother's unwillingness to continue the work ; creating the danger signs in pregnancy such as: bleeding, discharge, abortion
Age
From 16 years old to 39 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
91
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Mazandaran Univercity Of Medical Science
Street address
Serah Joybar , Emam khomeini square , Sari , Mazandaran
City
Sari
Postal code
Approval date
2015-06-06, 1394/03/16
Ethics committee reference number
IR.MAZUMS.REC.94.1411
Health conditions studied
1
Description of health condition studied
Anxiety
ICD-10 code
F41.1
ICD-10 code description
GENERALIZED ANXIETY DISORDERS
Primary outcomes
1
Description
State of Anxiety
Timepoint
4 weeks after The finishing of intervantion
Method of measurement
questionnare of espielberger
2
Description
Trait Anxiety
Timepoint
4 weeks after The finishing of intervantion
Method of measurement
Questionnare of espielberger
3
Description
Total Anxiety
Timepoint
4 weeks after The finishing of intervantion
Method of measurement
Questionnare of espielberger
Secondary outcomes
1
Description
Corellation of ُStudy Variables with Anxiety
Timepoint
4 weeks after interventin
Method of measurement
Questionnare
Intervention groups
1
Description
group counseling Consultations in 4 sessions of cognitive therapy sessions based on the identification cycle, thoughts, feelings and behavior in relation to the participants' anxiety.:
Category
Treatment - Other
2
Description
Interaction lecture Speeches by the way, fully interactive with participants , defined the position of the cycle amplifications anxiety,situation , thoughts,feelings , behavior, respectively.:
Category
Treatment - Other
3
Description
Control Group:T he group as a control group received only usual care during pregnancy:
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Health Center Of Number 7
Full name of responsible person
Mrs. Hafezian
Street address
Rahband , Center of Health 7 ,Sari ,Mazandaran
City
Sari
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran , Uavercity of Medical Science
Full name of responsible person
Dr ,Ravanbakhsh Esmaeili
Street address
Serah Joybar ,Square of Emam khomeini , Sari , Mazandaran
City
Sari
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran , Uavercity of Medical Science
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Mazandara Univercity of Medical Science
Full name of responsible person
Zohre Shahhosseini
Position
phd
Other areas of specialty/work
Street address
Vesal Nasibe School of Nursing and Midwifery ,Vesal Street , Amir Mazandarani Street , Sari , Mazandaran
City
Sari
Postal code
Phone
0089113329123
Fax
Email
Z.shahhosseini @mazums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran Univercity of Medical Science
Full name of responsible person
Fariba Salehi
Position
Masters
Other areas of specialty/work
Street address
Nasibe School of Nursing and Midwifery , Vesal Street , Amir Mazandarani Street , Sari , Mazandaran
City
Sari
Postal code
IRAN
Phone
+98 911 155 8302
Fax
Email
salehy.fariba@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran Univercity oF Medical Science
Full name of responsible person
Fariba Salehi
Position
Masters
Other areas of specialty/work
Street address
Nasibe School Of Nursing and Midwifery ,Vesal Street , Amir Mazandarani Street , Sari , Mazandaran
City
Sari
Postal code
Phone
+98 113392123
Fax
Email
salehy.fariba@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)