Evaluation the effectiveness of dialectical behavioral therapy on the fear of childbirth and preferred mode of delivery
Design
The clinical trial was conducted in two groups of intervention and control, Double blind, Randomized
Settings and conduct
Five counselling sessions are conducted for the intervention group in Mashhad’s center for comprehensive health services.For blinding ,neither the participants nor the analyzer know which participants belong to the control group, nor the intervention group.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Participation in childbirth classes, Singleton pregnancy, low risk pregnancy,Cut off score of fear of delivery above 28, Gestational age 22 to 24 weeks ,Desire to participate in study .Exclusion criteria: Not addicted to drugs
Intervention groups
The intervention group will receive consultation, weekly in five session.The control group will receive usual education for childbirth classes.
Main outcome variables
The primary outcome is fear of delivery that measured before and after intervention(counselling) and one month after intervention .The secondary outcome is the preference mode of delivery ,Which is measured after intervention.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180131038579N1
Registration date:2018-06-30, 1397/04/09
Registration timing:registered_while_recruiting
Last update:2018-06-30, 1397/04/09
Update count:0
Registration date
2018-06-30, 1397/04/09
Registrant information
Name
Zahra Ghasempoor
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3603 3219
Email address
zahraghasempour1367@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-06-22, 1397/04/01
Expected recruitment end date
2018-12-22, 1397/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating effectiveness of dialectic behavioral therapy on fear of childbirth and preferred mode of delivery
Public title
Evaluating effectiveness of dialectic behavioral therapy on fear of childbirth and preferred mode of delivery
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Ability to speak persian
Participate in childbirth classes
Singleton pregnancy
Having low risk pregnancy
Cut off scores fear of delivery above 28
No history of mental disorders and psychotropic drugs
Gestational age 22 to 24 weeks
Exclusion criteria:
Drug abuse
Missing consent of the pregnant mother to collaborate in the study
Age
From 18 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
72
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization, Statistical software
Blinding (investigator's opinion)
Double blinded
Blinding description
For blinding,neither the participants nor the analyzer know which participants belong to the control group, nor the test group.all Participants participate in childbirth classes but test group benefit from receiving counselling session in addition to usual classes.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shahroud university of medical sciences
Street address
Shahroud university of medical sciences,7th of Tir square
City
Shahroud
Province
Semnan
Postal code
36147-73947
Approval date
2018-03-06, 1396/12/15
Ethics committee reference number
IR.SHMU.REC.1396.159
Health conditions studied
1
Description of health condition studied
Dialectic behavioral therapy
ICD-10 code
ICD-10 code description
2
Description of health condition studied
Preference of mode of delivery
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Scores of fear in Harman's childbirth attitude questionnaire (CAQ)
Timepoint
Second (22-24 wk)and third trimester (32-36 wk)of pregnancy
Method of measurement
Harman's childbirth attitude questionnaire (CAQ)
Secondary outcomes
1
Description
Preferred mode of delivery
Timepoint
Third trimester of pregnancy 32-36 week
Method of measurement
Pregnant women's preferences for mode of delivery questionnaire
Intervention groups
1
Description
Intervention group: conselling
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Center for comprehensive health services
Full name of responsible person
Zahra Ghasempoor
Street address
Sanabad St.,Mashhad Town
City
Mashhad
Province
Razavi Khorasan
Postal code
9185684538
Phone
+98 51 3841 5001
Email
zahraghasempour1367@gmail.com
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Shahroud University of Medical Sciences Vice chancellor of research and technology
Street address
7th of Tir squere.,Shahroud Town
City
Shahroud
Province
Semnan
Postal code
3614773947
Phone
+98 23 3239 5054
Fax
+98 23 3239 5009
Email
info@shmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahroud 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
Shahroud University of Medical Sciences
Full name of responsible person
Zahra Ghasempoor
Position
midwife
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
No.87,Behvarz 3/6.,Falahi Blvd.,Mashhad town
City
Mashhad
Province
Razavi Khorasan
Postal code
9461933686
Phone
+98 51 3603 3219
Email
zahraghasempour1367@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Zahra Ghasempoor
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
No.87,Behvarz3/6.,Falahi Blvd.,Mashhad Town
City
Mashhad
Province
Razavi Khorasan
Postal code
9461933686
Phone
+98 51 3603 3219
Email
zahraghasempour1367@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Zahra Ghasempoor
Position
midwife
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
No.87,Behvarz3/6.,Falahi Blvd.,Mashhad Town
City
Mashhad
Province
Razavi Khorasan
Postal code
9461933686
Phone
+98 51 3603 3219
Email
zahraghasempour1367@gmail.com
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