Determining the effect of teaching coping strategies to fathers during pregnancy on couples' postpartum depression
Design
Controlled clinical trial with parallel groups, group assignment using balanced blocks randomization method with block size of 4 using online random assignment sequence generation, phase 3 trial.
Settings and conduct
The target group in the intervention is the husbands of pregnant women who will be identified and invited to the study through the comprehensive health centers of Qazvin city. The implementation of the intervention will be in the form of training for an individual on the platform of virtual networks in 5 sessions for 45 to 60 minutes in the form of lectures, questions and answers and presentation of educational booklets.
Participants/Inclusion and exclusion criteria
Admission criteria for mothers and fathers:
• Interested in taking part in the study
• Having minimum literacy
• First pregnancy (no history of miscarriage and stillbirth)
• Gestational age 30-32 weeks (based on the number of educational intervention sessions, which is five, and to have enough time to perform prenatal interventions, this gestational age was chosen.)
• Have a smartphone with internet access
• Staying in Qazvin city during the study
The exclusion criteria of mothers and fathers:
• High-risk pregnancy (according to the pregnancy file)
• History of psychological diseases in Mr. and Mrs. (self-report)
• Participating in similar training courses while studyin
Intervention groups
All pregnant women referring to comprehensive health centers in Qazvin city and their spouses
Main outcome variables
Postpartum depression - Coping strategies and perceived stress
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240220061061N1
Registration date:2024-03-23, 1403/01/04
Registration timing:registered_while_recruiting
Last update:2024-03-23, 1403/01/04
Update count:0
Registration date
2024-03-23, 1403/01/04
Registrant information
Name
reyhaneh mozaffari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 937 231 1546
Email address
reyhanhmzfry62.z@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-04-03, 1402/01/14
Expected recruitment end date
2024-09-05, 1403/06/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of prenatal coping strategies training to fathers on couples’ postpartum depression
Public title
Prenatal coping strategies training to fathers
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Criteria for entering the study of mothers:
Having minimum reading and writing literacy
First pregnancy with no history of abortion or stillbirth
Gestational age 30-32 weeks
Having a smartphone with internet access
Living in Qazvin during study time
Criteria for entering the study of fathers:
Having minimum literacy and ability to work with social networks
Their spouses first pregnancy without history of abortion and stillbirth
The gestational age of 30-32 weeks in their wives
Having a smartphone with internet access
Staying in Qazvin during the study period
Interested in participating in the study
Exclusion criteria:
Exclusion criteria for mothers:
History of psychological diseases in women (self-reported)
Participation in similar training courses at the time of study
High-risk pregnancy of the woman (according to the pregnancy file)
Exclusion criteria for fathers:
Participation in similar training courses at the time of study
High-risk pregnancy of the wife (according to the pregnancy file)
History of psychological illnesses in fathers (self-report)
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
86
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method with balanced blocks with a block size of 4 will be used for random assignment. In order to determine the allocation sequence using the 4 block method, online random allocation sequence generation software (https://www.sealedenvelope.com/simple-randomiser/v1/lists) will be used. In order to hide the assignment sequence, the papers specifying the group of people are placed inside the envelopes in the opaque package and coded in the same order. In this case, a questionnaire with the same code will be completed for the person who receives the code 1 intervention.
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
Research Ethics Committees of Qazvin University of Medical Sciences
Street address
Qazvin University of Medical Sciences-Shahid Bahonar Blvd-Nasr St-Qazvin-Iran
City
Qazvin
Province
Qazvin
Postal code
3419759811
Approval date
2024-02-18, 1402/11/29
Ethics committee reference number
IR.QUMS.REC.1402.397
Health conditions studied
1
Description of health condition studied
postpartum depression
ICD-10 code
F53
ICD-10 code description
Puerperal depression
Primary outcomes
1
Description
postpartum depression
Timepoint
One month after delivery
Method of measurement
Edinburgh postpartum depression questionnaire
Secondary outcomes
1
Description
Coping strategies
Timepoint
Before the intervention - after the intervention - one month after delivery
Method of measurement
Lazarus and Folkman Coping Strategies Questionnaire
2
Description
Perceived stress
Timepoint
Before the intervention - after the intervention - one month after delivery
Method of measurement
Cohens' Perceived stress
Intervention groups
1
Description
Intervention group: According to the entry criteria, we will enter 43 people. Considering that the target group in the intervention is education for spouses, in order to facilitate the implementation of the intervention and increase the participation rate, the training is done individually on the platform of virtual networks (with the participant's choice) and at a convenient time for them. The educational content will be presented in 5 sessions for 45 to 60 minutes in the form of lectures, questions and answers, and the presentation of educational booklets. Before the beginning of the meetings, the participants are told about the framework and objectives of the meetings. It should be noted that at the beginning of each session, the content of the previous session will be reviewed and the participants' feedback will be received. The content of the sessions: The first session: Familiarity with depression, the causes and role of various factors on it, and the recognition of the disease. In this session, the nature of depression, its symptoms and signs, the role of various genetic, environmental, and psychological factors and stimuli, etc. is expressed The second session: the principles of self-care. In this session, the participants are taught about the effects of depression and taking care of themselves and their spouses (nutrition, physical activity, family and spouse support, lifestyle changes, etc.). Family support, stressful and stressful conditions, family and economic issues and problems, sleep deprivation, reduction of women's independence and changes in the work environment, etc. are expressed with postpartum depression. The third session: depression management skills or behavioral techniques related to depression management in this The subjects' meeting to express their feelings (anxiety and depression) about depression and its symptoms and complications. They were also provided with information about psychosomatics. Postpartum depression symptoms, factors that increase it, strategies to reduce depression symptoms and techniques to increase Self-esteem and the relationship between the lack of support from the spouse and the postpartum depression of the woman are expressed. The fourth session: we will reset the attitude and analyze the false beliefs related to postpartum depression, which includes: recounting the false beliefs and irrational thoughts about the ineffectiveness of non-pharmacological methods - the significant effectiveness of the methods Non-pharmacology in reducing the intensity and frequency of postpartum depression - Identification of common non-pharmacology methods and their benefits - Easy and efficient learning of non-pharmacology strategies by each person. The fifth session: Training strategies for coping with the problem of stress and depression including: a review of the concepts of the previous session, training Coping strategies such as calming down and various methods of coping strategies and why they are expressed. The analysis and evaluation of the use of strategies by patients will be done with a focus on examples. Acquaintance with problem-oriented strategies and their application in depression control, providing home exercises, familiarization with emotion-oriented strategies and their application in depression control, and implementation of some strategies by the participants and providing verbal and practical feedback.
Category
Prevention
2
Description
Control group: In this group, we include 43 people according to the entry criteria and after obtaining a written consent, the only thing we do is to give the questionnaire form of coping strategies and perceived stress. After 5 weeks, we ask the control group to fill out the same forms again. One month after giving birth, they will fill out the coping strategies and perceived stress and postpartum depression questionnaire. This group will not be given any training.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Comprehensive health centers of Qazvin city
Full name of responsible person
reyhaneh mozaffari
Street address
Unit 1-Floor 1-Plate 57-Street 31 -University Street-Qazvin -Iran
City
Qazvin
Province
Qazvin
Postal code
3414678594
Phone
+98 919 783 5302
Email
reyhanhmzfry62.z@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Seyyed Mehdi Mirhashmi
Street address
Qazvin University of Medical Sciences-Shahid Bahonar Blvd-Nasr St-Qazvin-Iran
City
Qazvin
Province
Qazvin
Postal code
3419759811
Phone
+98 28 3333 6001
Email
mirhashemism@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qazvin 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
Qazvin University of Medical Sciences
Full name of responsible person
reyhaneh mozaffari
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Unit 1-Floor 1-Plate 57-Street 31 -University Street-Qazvin -Iran
City
Qazvin
Province
Qazvin
Postal code
3414678594
Phone
+98 919 783 5302
Email
reyhanhmzfry62.z@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
reyhaneh mozaffari
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Unit 1-Floor 1-Plate 57-Street 31 -University Street-Qazvin -Iran
City
Qazvin
Province
Qazvin
Postal code
3414678594
Phone
+98 919 783 5302
Email
reyhanhmzfry62.z@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
reyhaneh mozaffari
Position
MSc student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Unit 1-Floor 1-Plate 57-Street 31 -University Street-Qazvin -Iran
City
Qazvin
Province
Qazvin
Postal code
3414678594
Phone
+98 919 783 5302
Email
reyhanhmzfry62.z@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
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