This study has been done to determine the effectiveness of CBT on fetal maternal attachment in unintended pregnancy. Inclusion criteria are unintended pregnancy; low risk pregnancy; having at least primary education; gestational age between 22-28 weeks; singleton pregnancy; not having fetal death history; not having abortion history; not having mental disorder history. Exclusion criteria are continuous absence in cognitive behavioral therapy sessions; not fill out the follow-up questionnaire; severe pregnancy`s problems; severe anxiety. This study is a clinical trial consisting of 60 pregnant women. women with unintended pregnancies who gestational age is between 22-28 were randomly placed into two groups (case and control). Each group is included 30 members. Members of the two groups at the first meeting fill up the fetal maternal attachment cranley questionnaire. The case group will participate in 4 cognitive-behavioral group therapy sessions, and the control group receive routine pregnancy care. after the last session of therapy, the female participants will be asked to answer the post-test questionnaire, and the results will be compared with each other.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016092930048N1
Registration date:2017-08-01, 1396/05/10
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-08-01, 1396/05/10
Registrant information
Name
zohre ghseminasab
Name of organization / entity
Shahroud university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 3279 4679
Email address
ghaseminasab@shmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research; Shahroud University of Medical Sciences
Expected recruitment start date
2016-06-22, 1395/04/02
Expected recruitment end date
2017-06-22, 1396/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of cognitive- behavioral therapy on fetal maternal attachment in unwanted pregnancy
Public title
The effect of counseling on fetal maternal attachment in unwanted pregnancy
Purpose
Prevention
Inclusion/Exclusion criteria
Inclsion criteria: unintended pregnancy; low risk pregnancy; having at least primary education; gestational age between 22-28 weeks; singleton pregnancy; not having fetal death history; not having abortion history; not having mental disorder history
Exclusion criteria: continuous absence in cognitive behavioral therapy sessions; not fill out the follow-up questionnaire; severe pregnancy`s problems; severe anxiety
Age
From 15 years old to 48 years old
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
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
Ethics committee of Shahroud University of Medical Sciences
Street address
Central building of Shahroud University of Medical Sciences, HafteTirSquare, Shahroud
City
Shahroud
Postal code
3614773947
Approval date
2016-06-21, 1395/04/01
Ethics committee reference number
ir.shmu.rec.1395.22
Health conditions studied
1
Description of health condition studied
The effect of cognitive- behavioral therapy on fetal maternal attachment in unwanted pregnancy
ICD-10 code
026.9
ICD-10 code description
Pregnancy-related condition، unspecified
Primary outcomes
1
Description
Fetal maternal attachment
Timepoint
Befor and after intervention
Method of measurement
Cranley`s fetal maternal attachment Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
The intervention group attend 4 cognitive-behavioral therapy sessions. The intervention method is cognitive behavioral group therapy. session has a certain structure
Category
Treatment - Other
2
Description
The control group receive routine pregnancy care
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Urban health center
Full name of responsible person
Zohre ghaseminasab
Street address
Central building of Shahroud University of Medical Sciences, HafteTirSquare, Shahroud
City
Shahroud
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research; Shahroud University of Medical Sciences
Full name of responsible person
Dr Mohammadhasan Emamian
Street address
Central building of Shahroud University of Medical Sciences, HafteTir Square, Shahroud
City
Shahroud
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research; Shahroud University of Medical Sciences
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
Shahroud University of Medical Sciences
Full name of responsible person
Zohre ghaseminasab
Position
Master science of student counseling midwifery
Other areas of specialty/work
Street address
Central building of Shahroud University of Medical Sciences, HafteTir Square, Shahroud
City
Shahroud
Postal code
3614773947
Phone
+98 23 3239 5054
Fax
Email
ghasemi136993@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Dr Zahra Motaghi
Position
PHD
Other areas of specialty/work
Street address
Central building of Shahroud University of Medical Sciences, HafteTirSquare, Shahroud
City
Shahroud
Postal code
3614773947
Phone
+98 23 3239 5054
Fax
Email
zhrmotaghi@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Zohre ghaseminasab
Position
Master science of student counseling midwifery
Other areas of specialty/work
Street address
Central building of Shahroud University of Medical Sciences, HafteTir Square, Shahroud
City
Shahroud
Postal code
3614773947
Phone
+98 23 3239 5054
Fax
Email
ghasemi136993@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)