The effect of midwifery counseling based on gamble approach on depression, anxiety, posttraumatic stress disorder after traumatic childbirth in nulliparous women
This Study is a randomized clinical trial. In the first stage, stratified sampling will be done from all health centers of the Zanjan University of Medical Sciences. At first, two centers will be selected randomly from each socio-economic areas, then 520 mothers who are in the third trimester of pregnancy and affiliated to these centers will be selected based on stratified sampling. The maternal depression will be screened based on the Edinburgh scale. Then those without depression, the age range between 18 to 35 years old, with a single pregnancy, willing to participate in the study and can read, write and understand the Persian language will enter to the second stage. In the second stage, during the first 72 hours after birth, women will be screened for traumatic childbirth using a DSM-5 scale. Then, 90 subjects who have experienced traumatic childbirth will be selected by convenience sampling and will be allocated into two groups of intervention (n = 45) and control (n = 45) on the random blocked allocation. The intervention group will receive counseling and the control group will receive usual care after childbirth. After the last session, the questionnaire will be completed in both the intervention and control groups by a trained interviewer who is unaware of the group assignment of the women.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201608285417N2
Registration date:2017-02-21, 1395/12/03
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-02-21, 1395/12/03
Registrant information
Name
Elham Jafari
Name of organization / entity
Zanjan university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 72725130241
Email address
ejafari@zums.ac.ir
Recruitment status
Recruitment complete
Funding source
Zanjan University of Medical Sciences
Expected recruitment start date
2016-11-06, 1395/08/16
Expected recruitment end date
2017-02-04, 1395/11/16
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of midwifery counseling based on gamble approach on depression, anxiety, posttraumatic stress disorder after traumatic childbirth in nulliparous women
Public title
The effect of midwifery counseling based on gamble approach on depression, anxiety, posttraumatic stress disorder after traumatic childbirth in nulliparous women
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: 18 to 35 years old; Single pregnancy; nulliparous; willingness to participate in the study; the ability to complete the questionnaire; the ability to speak to Persian language; no history of miscarriage; stillbirth and infertility; no history of depression during pregnancy; the lack of a history of postpartum depression in first-degree relatives; not using drugs that can cause symptoms of depression (such as anti-epileptic; antihypertensive; steroids; anti-Parkinson's and sedative drugs); no history of mental illness; lack of psychological and medical treatment. No Chronic illnesses and diseases that are caused depression (epilepsy, multiple sclerosis, migraine); non-occurrence of a traumatic event in recent year (such as relative or husband’s death; the occurrence of sudden financial problems; marital problems and divorce, drug abuse). Exclusion criteria included: changing living area so that she not available; newborn congenital anomalies, mothers or their infants who will need special care; Having no tendency to continue the study.
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:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
random blocked allocation
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Zanjan University of Medical Sciences, First floor, North Side Azadi Boulevard,
Street address
Zanjan
City
Zanjan
Postal code
Approval date
2016-11-02, 1395/08/12
Ethics committee reference number
Zums.rec.1395.197
Health conditions studied
1
Description of health condition studied
traumatic childbirth
ICD-10 code
F43.1
ICD-10 code description
Arises as a delayed or protracted response to a stressful event or situation (of either brief or long duration) of an exceptionally threatening or catastrophic nature, which is likely to cause pervasive distress in almost anyone
Primary outcomes
1
Description
Post-traumatic stress disorder
Timepoint
4-6 weeks after intervention and 3 months after delivery.
Method of measurement
Post-traumatic stress disorder scale
Secondary outcomes
1
Description
depression
Timepoint
4-6 weeks after intervention and 3 months after delivery.
Method of measurement
Edinburgh Depression scale
2
Description
anxiety
Timepoint
4-6 weeks after intervention and 3 months after delivery.
Method of measurement
Hamilton Anxiety scale scale
Intervention groups
1
Description
the control group will receive usual care after childbirth.
Category
Prevention
2
Description
In the intervention group, face to face and telephone consultations will be conducted in two sessions.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Ayatollah Mousavi Hospital
Full name of responsible person
Leila Asadzadeh
Street address
Ayatollah Mousavi Hospital, Road Gavazang, Zanjan
City
Zanjan
2
Recruitment center
Name of recruitment center
Imam Hossein Hospital
Full name of responsible person
Leila Asadzadeh
Street address
Imam Hossein Hospital, Farhang Street, Zanjan
City
Zanjan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Chancellor for Research and Technology of Zanjan University of Medical Sciences, First floor, North
Full name of responsible person
Dr Alireza Shoghli
Street address
North Side Azadi Boulevard Zanjan
City
Zanjan
Grant name
پایان نامه
Grant code / Reference number
A-11-326-3
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Chancellor for Research and Technology of Zanjan University of Medical Sciences, First floor, North
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
Zanjan University of Medical Sciences
Full name of responsible person
Leila asadzadeh
Position
Msc student of Midwifery Counseliing
Other areas of specialty/work
Street address
500 Dastgah Street,The Last Station
City
Gachsaran
Postal code
7581856887
Phone
+98 935 827 1786
Fax
Email
leila.asadzadeh@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Elham jafari
Position
Master of Midwifery
Other areas of specialty/work
Street address
School of Nursing and Midwifery
City
zanjan
Postal code
Phone
+98 912 241 3897
Fax
Email
elhamdjafari@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Elham jafari
Position
Master of Midwifery
Other areas of specialty/work
Street address
School of Nursing and Midwifery
City
zanjan
Postal code
Phone
+98 912 241 3897
Fax
Email
elhamdjafari@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)