Effectiveness of dialectical behavioral therapy to postpartum depression rate and breastfeeding success in traumatic childbirth
Design
Two arm parallel groups randomized trial with blinded postoperative care and outcome assessment. The control group just take routine cares and intervention group will receive consultation, weekly in five session. Post test will be done for both groups.
Settings and conduct
Location of study: Bahar hospital, Shahrood city
In the beginning of study the traumatic childbirth scale will complete by primiparous women who come to hospital for delivery.
If they have suffered by traumatic childbirth in the second step they will complete postpartum depression scale and if they get the point under 10, they can participate in the study.
The participants of each group do not aware about Existence of another group. Researcher dose not aware about randomized allocation because of closed packets. After intervention questionnaires will complete by another person except researcher. The analyzer dose not aware about the people in the group's neither
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Giving healthy birth
Having literacy
Ability to speak and realize persia
Desire to participate in study
Not addicted to drugs
Not occur stressful accidents before, in pregnancy
No background of mental illnesses or using psychological drugs before, in or After pregnancy
Lack of getting chronic and hard diseases before, in and after pregnancy
Not use drugs can lead to depression symptoms
Attaining point 10 or more in edinburg postpartum depression scale
Intervention groups
All of primiparous women
Main outcome variables
effectiveness of dialectical behavioral therapy on postpartum depression rate
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180108038265N1
Registration date:2018-04-30, 1397/02/10
Registration timing:registered_while_recruiting
Last update:2018-04-30, 1397/02/10
Update count:0
Registration date
2018-04-30, 1397/02/10
Registrant information
Name
Niloofar Rabiee
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 23 3237 1061
Email address
n.rabiee2016@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-03-21, 1397/01/01
Expected recruitment end date
2018-07-23, 1397/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of Dialectical Behavioral Therapy to Postpartum Depression Rate and Breastfeeding Success in Traumatic Childbirth
Public title
Effectiveness of Dialectical Behavioral Therapy to Postpartum Depression
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Giving healthy birth
Having literacy
Ability to speak and realize persian
Tend to participate in study
Not addicted to drugs
Not occur stressful accidents before, in pregnancy
No background of mental illnesses or using psychological drugs before, in or after pregnancy
Lack of getting chronic and hard diseases before, in and after pregnancy
Not use drugs can lead to depression symptoms
Exclusion criteria:
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
180
Randomization (investigator's opinion)
Randomized
Randomization description
The randomized sequences under the web and by person who out of the research team will be done. Randomized foursome block as a limited method will be used and the people in the order of arrival will stay on blocks.
The researcher put each allocation in closed white packet and numbered it.Qualified people in the order of arrival will be register by researcher and receive a code and the basic questionnaire complete for theme.Then according to the codes one packet will be opened and the person will be allocated to one of the groups.
Blinding (investigator's opinion)
Triple blinded
Blinding description
The Participants of each group do not aware about existence of another group. Researcher dose not aware about randomized allocation because of closed packets. After intervention questionnaires will complete by another person except researcher. The analyzer dose not aware about the people in the groups nether
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahrood University of Medical Sciences
Street address
7th tir square, shahrood University of Medical Sciences
City
shahrood
Province
Semnan
Postal code
3614773947
Approval date
2017-12-16, 1396/09/25
Ethics committee reference number
960227
Health conditions studied
1
Description of health condition studied
Postpartum depression, traumatic childbirth
ICD-10 code
F53
ICD-10 code description
Puerperal psychosis
Primary outcomes
1
Description
Postpartum depression that will be measure by Edinburg scale
Timepoint
Before initiate of intervention, Immediately after the end of intervention, In the follow up, One month later ( the end of 12th week after delivery)
Method of measurement
Postpartum depression scale of Edinburg
Secondary outcomes
empty
Intervention groups
1
Description
Control group: dose not recieve any intervention
Category
Behavior
2
Description
Intervention group: this group will recieve the consultation (dialectical behavioral therapy)
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Bahar hospital
Full name of responsible person
Narges Sarkardeie
Street address
22 bahman St, Bahar hospital
City
shahrood
Province
Semnan
Postal code
۳۶۱۴۷-۷۳۹۴۷
Phone
+98 23 3239 5054
Email
info@shmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
student's research comitte
Street address
7th tir square, Shahroud University of Medical Sciences
City
shahrood
Province
Semnan
Postal code
۳۶۱۴۷-۷۳۹۴۷
Phone
+98 23 3239 5054
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
Niloofar Rabiee
Position
midwife
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
25th Alley, tehran Ave
City
shahrood
Province
Semnan
Postal code
3614646118
Phone
+98 23 3237 1061
Email
n.rabiee2016@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Niloofar Rabiee
Position
midwife
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
tehran Ave
City
shahrood
Province
Semnan
Postal code
3614646118
Phone
+98 23 3237 1061
Email
n.rabiee2016@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Niloofar Rabiee
Position
midwife
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
tehran Ave
City
shahrood
Province
Semnan
Postal code
3614646118
Phone
+98 23 3237 1061
Email
n.rabiee2016@gmail.com
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
puplishable data include thesis interpreted results and papers and protocol if needed
When the data will become available and for how long
Access from 2018-2019
To whom data/document is available
Data are access for all researchers in scientific institudes
Under which criteria data/document could be used
In case of Author's permission
From where data/document is obtainable
To corresponding author or executive author
What processes are involved for a request to access data/document
By contact with the departmant or send an email to authors