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
-
-
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
-
-
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.
Ethics committees
1
-
Ethics committee
-
-
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)
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
1
-
Sponsor
-
-
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
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
-
No - There is not a plan to make this available
-
Statistical Analysis Plan
-
No - There is not a plan to make this available
-
Informed Consent Form
-
No - There is not a plan to make this available
-
Clinical Study Report
-
No - There is not a plan to make this available
-
Analytic Code
-
No - There is not a plan to make this available
-
Data Dictionary
-
No - There is not a plan to make this available