Study of the Effect of Deep Feeling Expression of Labor Experiences in a Virtual Pear Group on Post-Traumatic Stress Disorder Symptoms and Postpartum Depression
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General information
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154
154
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2019-05-05, 1398/02/15
2019-05-05 00:00:00
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2019-10-22, 1398/07/30
2019-10-22 00:00:00
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2020-01-20, 1398/10/30
2020-01-20 00:00:00
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Enter the start and end dates of sampling
Enter the start and end dates of sampling
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وارد کردن تاریخ شروع و پایان نمونه گیری
وارد کردن تاریخ شروع و پایان نمونه گیری
Protocol summary
Study aim
We hope that through this intervention, we can help women by eliminating inconvenient memories of childbirth, which will make their later births normal, and reduce the number of cesarean sections.
Design
The clinical trial included two intervention and control groups
Settings and conduct
The researcher visits the Dr. Rahimi Hospital in Birjand daily and will begin sampling in an accessible (easy) manner after obtaining informed consent from eligible women. Then, the research units were divided into two groups of intervention and control, using four-dimensional permutation blocks. First, 6 possible blocks are listed (AABB, ABAB, BBAA, BABA, ABBA, BAAB) and each block is assigned a number from one to six. Then they are randomly assigned to the experimental (A) and control (B) groups using a random number table from one to six, followed by a block based on the number chosen. The participants are those who are blind.
Participants/Inclusion and exclusion criteria
Inclusion criteria: No psychotherapy has been received. The absence of diagnosed mental disorders, including depression, anxiety in recent weeks.
Exclusion criteria: Have symptoms of post traumatic stress disorder and postpartum depression.
Intervention groups
The intervention group consisted of delivery mothers who expressed their experiences and feelings of childbirth in the group.
The control group consisted of delivery mothers who talked about daily life events or about daily baby care experiences.
Main outcome variables
Eradication of unpleasant childbirth memories; Attitude towards normal childbirth; Change in the method of delivery in postpartum; Change in postpartum depression; Change in symptoms of perinatal traumatic stress disorder.
General information
Reason for update
Enter the start and end dates of sampling
Acronym
IRCT registration information
IRCT registration number:IRCT20190610043859N1
Registration date:2019-08-12, 1398/05/21
Registration timing:registered_while_recruiting
Last update:2021-12-18, 1400/09/27
Update count:1
Registration date
2019-08-12, 1398/05/21
Registrant information
Name
Azam Mohammadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 5722 3028
Email address
azammohammadi96.97@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-06-26, 1398/04/05
Expected recruitment end date
2019-09-22, 1398/06/31
Actual recruitment start date
2019-05-05, 1398/02/15
Actual recruitment end date
2019-10-22, 1398/07/30
Trial completion date
2020-01-20, 1398/10/30
Scientific title
Study of the Effect of Deep Feeling Expression of Labor Experiences in a Virtual Pear Group on Post-Traumatic Stress Disorder Symptoms and Postpartum Depression
Public title
Investigating the effect of expressing deep feelings on the experiences of labor stages on post traumatic stress and postpartum depression
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
A tendency to participate in the study
Have access to the Internet and use social media
Term pregnancy, natural vaginal delivery and lead to the birth of a newborn baby.
Be able to converse and write in Persian
Have at least fifth grade elementary education (full read and write mastery)
Psychotherapy has not been received
The absence of diagnosed mental disorders, including depression, anxiety in recent weeks
Earn less than 12 points in the Edinburgh Depression Inventory
Gain less than 19 points in Perinatal Post Traumatic Stress Disorder Questionnaire
Exclusion criteria:
Baby death
Stressful events like loss of a family member
Baby admission
Maternal admission in postpartum period
Cancellation of the continuation of the study
Lack of activity in social media group for 2 consecutive days
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
170
Actual sample size reached:
154
Randomization (investigator's opinion)
Randomized
Randomization description
The researcher will begin sampling by making available accessible (easy) sampling by referring to the obstetrics and gynecology department of Shahid Rahimi hospital in Birjand. . Then, the research units were divided into two groups of intervention and control, using four-dimensional permutation blocks. First, 6 possible blocks are listed (AABB, ABAB, BBAA, BABA, ABBA, BAAB) and each block is assigned a number from one to six. Then they are randomly assigned to the experimental (A) and control (B) groups using a random number table from one to six, followed by a block based on the number chosen. This will continue until the sample size is complete.
Blinding (investigator's opinion)
Single blinded
Blinding description
Participants were kept blind and did not know the two groups of intervention and control.
Placebo
Not used
Assignment
Parallel
Other design features
The aim of this study was to determine the effect of expressing deep feelings on the experiences of delivery stages in the counterpart group on post traumatic stress and postpartum depression symptoms. It is important to note that the reduction of post traumatic stress disorder following a natural birth can be an attempt to eliminate unpleasant memories of childbirth that may have been created for any reason. Since previous studies have shown that one of the important factors in cesarean delivery after a traumatic natural delivery is the fear of giving birth due to the unpleasant memories of the previous delivery, the researchers hope that the use of intervention will influence the expression of deep feelings from the experiences of the stages of labor in the group Virtual counterparts to post-traumatic stress and postpartum depression can help women by eliminating inconvenient memories of childbirth, which will continue their normal delivery in the normal way, and can reduce the number of cesarean sections.
Secondary Ids
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Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee in Gonabad University of Medical Sciences
Street address
Asian Roads of Gonabad University of Medical Sciences
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Approval date
2019-03-17, 1397/12/26
Ethics committee reference number
IR.GMU.REC.1397.133
Health conditions studied
1
Description of health condition studied
Post-Traumatic Stress Disorder Symptoms and Postpartum Depression
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Depression Score
Timepoint
Before entering the study and study completion, and three months after delivery
Method of measurement
Postpartum Depression Inventory of Edinburgh
2
Description
Perinatal Traumatic Stomach Disorder Score
Timepoint
Before entering the study and study completion, and three months after delivery
Method of measurement
Prenatal Post Traumatic Stress Disorder Questionnaire (PPQ)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: This group will be asked to identify the deepest thoughts and feelings they experienced during their stay in labor and delivery during the two weeks and twice a day (for example, hospitalization, family relationships). , Other Patients, Birth Experiences, Child Delivery) and what they are currently feeling about these events.
Category
N/A
2
Description
Control group: The control group will be asked to share information on daily life events or daily baby care experiences for two weeks in the virtual telegram messaging group.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Dr. Rahimi Hospital
Full name of responsible person
Mehrnegar Amirshahi
Street address
Shahid Tahmasebi Shahid Rahimi Hospital
City
Birjand
Province
South Khorasan
Postal code
9717613112
Phone
+98 56 3243 5012
Email
rahimi.hos@tamin.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Dr. Shahla Khosrowan
Street address
Asian Roads of Gonabad University of Medical Sciences
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Phone
+98 51 5722 3028
Email
info@gmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Gonabad University of Medical Sciences
Proportion provided by this source
10
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
Gonabad University of Medical Sciences
Full name of responsible person
Dr Narjes Bahri
Position
Instructor and faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Asian Roads of Gonabad University of Medical Sciences
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Phone
+98 51 5722 3028
Email
bahribn901@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Azam Mohammadi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Asia Blvd., Gonabad University of Medical Sciences., Gonabad Town
City
Gonabad
Province
Razavi Khorasan
Postal code
9717613112
Phone
+98 51 5722 3028
Fax
Email
azammohammadi96.97@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Dr Narjes Bahri
Position
Instructor and faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Asian Roads of Gonabad University of Medical Sciences
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Phone
+98 51 5722 3028
Email
bahribn901@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