Protocol summary

Study aim
Comparison of the effectiveness of paired counseling with two cognitive-behavioral and decision-based approaches in the prevention of postpartum distress and postpartum depression in pregnant women. If counseling is effective in reducing postpartum depression, these sessions can be considered.
Design
Clinical practice is a non-randomized, cross-sectional one-blind clinical trial.
Settings and conduct
At first, grief questionnaires, postpartum depression, and DOS depression questionnaire by couples, which are needed for matching, are given to people who are referred to Mobinini Hospital in Sabzevar, and then eligible wives of their spouses in the counseling classes are present at the intervention sessions.
Participants/Inclusion and exclusion criteria
Minimal primary education ,No history of previous mental illnesses , Failure of the physician to rest absolutely , No illness Chronic ,Do not addict, Earn score below 15 in the DASS questionnaire by yourself and the spouse. ;The occurrence of any stressful incident for a patient or class members of a pregnant woman, diagnosis of mental illness and psychiatric disorders, dissatisfaction and lack of interest in continued cooperation, absence of more than 2 sessions in counseling sessions, abnormalities and deaths.Abnormalities and fetal death
Intervention groups
Includes two groups: 1. An intervention group that must participate in conjugal counseling classes in addition to attending birth-preparation classes. 2. The attending group attending prepayment classes. Ultimately this We compare the two groups together.
Main outcome variables
Cognitive-qualitative-nominal-independent-grouping-has or not. Qualitative-nominal solution-Independent -group-Ordinary or not. Distress after childbirth - a little bit of continuity - no doubt - and a questionnaire-an issue Postpartum depression - Continuously-Nonspecific-Affected-Grouping-Neutral

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190204042622N1
Registration date: 2019-07-16, 1398/04/25
Registration timing: registered_while_recruiting

Last update: 2019-07-16, 1398/04/25
Update count: 0
Registration date
2019-07-16, 1398/04/25
Registrant information
Name
Atefe Beyhaghi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3752 3023
Email address
abeyhaghi76@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-06-05, 1398/03/15
Expected recruitment end date
2020-04-03, 1399/01/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effectiveness of couple counseling based on cognitive-behavioral and Solution-focused approaches to prevention of postpartum ‎ blues and depression in pregnant women .
Public title
Comparison of the effectiveness of couple counseling based on cognitive-behavioral and Solution-focused approaches to prevention of postpartum ‎ blues and depression in pregnant women .
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
1-Minimum Elementary Education 2. Not a history of mental illness in the past, such as schizophrenia, depression, anxiety and ... 3. Participation in childbirth classes 4. Failure of the physician to rest absolutely absolute 5. The absence of chronic diseases 6. Non-addiction 7- Earn score below 15 in the DASS questionnaire by yourself and the spouse 8. The absence of mental illness in a spouse.
Exclusion criteria:
The occurrence of any stressful incident for a patient or class members of a pregnant woman's family Diagnosis of mental illness and psychiatric disorders (mood disorders such as depression, anxiety disorder and the diagnosis of a patient's illness and any other illness during the study) Dissatisfaction and lack of interest in continued cooperation Missing more than 2 sessions in counseling sessions Abnormalities and fetal deaths and termination of pregnancy before the end of counseling sessions
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
Sample size
Target sample size: 45
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
First, in person by interviewing pregnant women and filling out the questionnaire of sadness and depression by pregnant women, as well as filling the DASS depression questionnaire by couples, qualified people to attend counseling classes, and by telephone to obtain their consent for participation It was done in classes. Using the six-point block table, the samples were grouped into three groups and equalized, and by matching the score of 15 couples in the DASS questionnaire, this would be matched. In this study, all participants were asked how they assigned the group They are unaware of the fact that the investigator, the safety committee and the supervisors are aware of how the people are assigned.
Placebo
Used
Assignment
Crossover
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Sabzevar University of Medical Sciences
Street address
Tohid Town, Above Anonymous Martyrs, Campus Medical Sciences Complex
City
Sabzevar
Province
Razavi Khorasan
Postal code
9613873136
Approval date
2019-05-24, 1398/03/03
Ethics committee reference number
IR.MEDSAB.REC. 1398.018

Health conditions studied

1

Description of health condition studied
blues and postpartum depression
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Cognitive-qualitative-nominal-independent-grouping-has or not. Qualitative-nominal solution-Independent -group-Ordinary or not. Distress after childbirth - a little bit of continuity - no doubt - and a questionnaire-an issue . Postpartum depression - Continuously-Nonspecific-Affected-Grouping-Neutral . Mental health is a little continuously a disturbing proportion of the score questionnaire.
Timepoint
Death grief questionnaire after Stein's birth during 3-5 days after childbirth. Postpartum diaphysmicity questionnaire in Edinburgh on the 15th day after childbirth.
Method of measurement
Death grief questionnaire after Stein's birth during 3-5 days after childbirth. Postpartum diaper delivery questionnaire on the 15th day after childbirth. Dos depression questionnaire for couples before counseling.

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: In addition to participating in childbirth classes, intervention groups are accompanied by a spouse in interventional sessions. The Cognitive-Behavioral Counseling Group will participate in 4 1-hour sessions and an Axis Solutions in 3 1-hour sessions.
Category
Prevention

2

Description
Control group: Witnesses attend routine classes for childbirth. Due to the increasing sample size, each group of people is in the subgroups of 8 to 12 people.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahidan Mobini Hospital in Sabzevar
Full name of responsible person
Masoumeh Sharifzadeh
Street address
North Kashfi Avenue
City
Sabzevar
Province
Razavi Khorasan
Postal code
9613873136
Phone
+98 51 4423 8103
Email
mobini.h@medsab.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Masoumeh Sharifzadeh
Street address
Blvd. Tohid Shahr, above the unknown martyrs, Campus building
City
Sabzevar
Province
Razavi Khorasan
Postal code
9613873136
Email
info@medsab.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sabzevar 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
Sabzevar University of Medical Sciences
Full name of responsible person
Masoumeh Sharifzadeh
Position
professor
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Shahidan Mobini Hospital in Sabzevar
City
Sabzevar
Province
Razavi Khorasan
Postal code
9613873136
Phone
+98 935 678 0225
Email
msharifzade@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Masoumeh Sharifzadeh
Position
professor
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Shahidan Mobini Hospital
City
Sabzevar
Province
Razavi Khorasan
Postal code
9613873136
Phone
+98 935 678 0225
Email
msharifzade@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Atefeh Bayhaghi
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Sabzevar University of Medical Sciences
City
Sabzevar
Province
Razavi Khorasan
Postal code
9613873136
Phone
+98 939 160 4824
Email
abeyhaghi76@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
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