To define effect of midwife-led postpartum counseling on psychological distress in women with traumatic childbirth
Design
A clinical trial with a control group, with parallel, unblinded, randomized groups, and random blocked allocation
Settings and conduct
At first, pregnant women referred to prenatal care clinic Imam Ali Hospital who have inclusion criteria will be selected. Then, during the first 72 hours after birth, women will be screened for traumatic childbirth using a DSM-IV scale. 96 subjects with traumatic experienced childbirth will be selected by convenience sampling and allocated into two groups of intervention and control. At 12 weeks after delivery, the questionnaires will be completed again in both groups by a trained interviewer who is unaware of the group assignments.
Participants/Inclusion and exclusion criteria
Inclusion criteria: aged18-35 years; mother's willingness and consent to participate in the study; singleton pregnancy; ability to complete questionnaires; traumatic childbirth;
Exclusion criteria: history of infertility; history of abortion; history of stillbirth; history of postpartum depression in first-degree relatives; depression during pregnancy; mental illness; medical disorder; occurrence of an unfortunate accident during the last 6 months
Intervention groups
In the intervention group, counseling by the midwife is performed on the basis of "the Gamble's strategy" individually for 3 sessions, one sessions of face-to-face contact consultation during the first 72 hours after child birth and two session of telephone consultations in the fourth week and the eighth week after delivery, ranging 40 - 60 minutes. For the control group, usual care after childbirth is provided.
Main outcome variables
psychological distress
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221024056280N1
Registration date:2023-05-15, 1402/02/25
Registration timing:prospective
Last update:2023-05-15, 1402/02/25
Update count:0
Registration date
2023-05-15, 1402/02/25
Registrant information
Name
Mouloud Aghajani Delavar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3227 4881
Email address
moloodaghajani@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-05-22, 1402/03/01
Expected recruitment end date
2023-11-22, 1402/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of midwife-led postpartum counseling on psychological distress in women with traumatic childbirth
Public title
Effectiveness of midwife-led postpartum counseling on psychological distress
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
age range 18-35 years
mother's willingness and consent to participate in the study
singleton pregnancy
ability to complete questionnaires
Exclusion criteria:
history of infertility
history of abortion
history of stillbirth
history of postpartum depression in first-degree relatives
depression during pregnancy
mental illness
medical disorder
occurrence of an unfortunate accident during the last 6 months
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:
96
Randomization (investigator's opinion)
Randomized
Randomization description
The sequence of random allocation and the list of blocks will be obtained with the help of software (https://www.sealedenvelope.com) in blocks of 4. Blocking and allocation sequence for concealment will be done by a person not involved in the research. The allocation ratio of the samples will be 1.1 and will be placed in two groups receiving counseling and control. Then, based on the obtained blocks and the sequence of allocation, counseling will be given to the patients who reported a traumatic childbirth. This is an open-label study and blinding will not happen.
Blinding (investigator's opinion)
Not 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 Babol University of Medical Sciences
Street address
Babol University of Medical Sciencesol, Ganj Afrooz Ave, Daneshga Blvd, Babol
City
Babol
Province
Mazandaran
Postal code
۴۷۱۷۶-۴۷۷۴۵
Approval date
2023-03-06, 1401/12/15
Ethics committee reference number
IR.MUBABOL.REC.1401.176
Health conditions studied
1
Description of health condition studied
postpartum psychological distress
ICD-10 code
O90.6
ICD-10 code description
Postpartum mood disturbance
Primary outcomes
1
Description
postpartum psychological distress
Timepoint
Measurement at the beginning of the study (before the start of the intervention) and 12 weeks after birth
Method of measurement
Using Stanford Acute Stress Reaction Questionnaire, Impact of Event Scale - Revised, and post-traumatic stress checklist inventory
Secondary outcomes
1
Description
State-trait anxiety inventory
Timepoint
Before the intervention and 12 weeks after child birth
In the intervention group, counseling is performed on the basis of "the Gamble's strategy" individually for 3 sessions, one sessions of face-to-face contact consultation during the first 72 hours after child birth and two session of telephone consultations in the fourth week and the eighth week after delivery, ranging 40 - 60 minutes by the researcher midwife. The counseling intervention is consistent with trauma theory and draws on cognitive behavioral therapy principles (C B T). Counseling strategies provided women with opportunities to talk about their birth experience, express feelings about what happened. The counseling intervention including fostering social support, reinforcing positive approaches to coping and exploring solutions to restoring self-confidence and reducing anxiety.
Category
Prevention
2
Description
Control group: The control group will be received usual care after childbirth.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Ali Hospital
Full name of responsible person
Mouloud Aghajani Delavar
Street address
Imam Ali Hospital, Chamestan Ave, Shaykh Faslolah Nori Ave, Amol
City
Amol
Province
Mazandaran
Postal code
41497- 46171
Phone
+98 11 4426 4661
Email
info@scanteb.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Mehdi Rajabnia
Street address
Babol University of Medical Sciences, Ganj Afrooz Ave, Daneshga Blvd, Babol
City
Babol
Province
Mazandaran
Postal code
۴۷۱۷۶-۴۷۷۴۵
Phone
+98 11 3219 7667
Email
research@mubabol.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Babol 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
Babol University of Medical Sciences
Full name of responsible person
Mouloud Aghajani Delavar
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Babol University of Medical Sciences, Ganj Afrooz Ave, Daneshga Blvd, Babol
City
Babol
Province
Mazandaran
Postal code
۴۷۱۷۶-۴۷۷۴۵
Phone
+98 11 3219 9592
Email
molooodaghajani@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Mouloud Aghajani Delavar
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Babol University of Medical Sciences, Ganj Afrooz Ave, Daneshga Blvd, Babol
City
Babol
Province
Mazandaran
Postal code
۴۷۱۷۶-۴۷۷۴۵
Phone
+98 11 3219 9592
Email
molooodaghajani@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Mouloud Aghajani Delavar
Position
Proffesor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Babol University University of Medical Sciences, Ganj Afrooz, Daneshga Blv, Babol
City
Babol
Province
Mazandaran
Postal code
4717647745
Phone
+98 11 3236 0714
Email
moloodaghajani@yahoo.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