Determining the effect of counseling with a positivist approach on postpartum depression in adolescent pregnant women
Design
A clinical trial with a control group, with parallel, randomized groups, will be performed on 46 patients.
Settings and conduct
The study population will be selected from adolescent pregnant mothers referring to comprehensive health centers in Zanjan. There is no blinding in this study
Participants/Inclusion and exclusion criteria
Inclusion criteria: Adolescent pregnant mothers under 19 (19-13 years);
Having an education, at least first guidance;
First pregnancy;
28 weeks of pregnancy;
A living fetus with no abnormalities;
Single pregnancy;
Mothers' consent to participate in the research project;
Internet and Android phone access.
Non-inclusion criteria:
History of drug use;
Pregnancy problems (bleeding - placenta previa, preeclampsia);
Existence of psychiatric disorders in adolescent pregnant mothers.
Intervention groups
Intervention group: In the 26th to 28th weeks of pregnancy, positivism counseling sessions will be held individually using the telephone and cyberspace through 8 60-90 minute sessions once a week for 8 weeks.
Control group: routine pregnancy care will be provided.
Main outcome variables
Postpartum Depression
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160521027994N8
Registration date:2021-07-20, 1400/04/29
Registration timing:registered_while_recruiting
Last update:2021-07-20, 1400/04/29
Update count:0
Registration date
2021-07-20, 1400/04/29
Registrant information
Name
Taraneh Emamgholi khooshehchin
Name of organization / entity
Zanjan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 24 3314 8318
Email address
khoosheh@zums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-06-22, 1400/04/01
Expected recruitment end date
2021-12-22, 1400/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of group counseling with a positivist approach on postpartum depression in adolescent mothers
Public title
The effect of counseling on postpartum depression
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Adolescent pregnant mothers under 19 (19-13 years)
Having an education, at least first guidance
First pregnancy
28 weeks of pregnancy
A living fetus with no abnormalities
Single pregnancy
Mothers' consent to participate in the research project
Internet and Android phone access
Exclusion criteria:
History of drug use
Pregnancy problems (bleeding - placenta previa, preeclampsia)
Existence of psychiatric disorders in adolescent pregnant mothers (individuals who earn score 9 or lower on the General Health Instrument (GHQ-12).
Incidence of stressful events (accidents, death of a loved one, separation from a spouse, bankruptcy, severe disputes, immigration), in the last 6 months
Underlying disease (including diabetes mellitus, cardiovascular and other chronic diseases)
Age
From 13 years old to 19 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
46
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, first, the easy sampling method will be used and then individuals with inclusion criteria will be divided into two groups of intervention and control using random block division. In this way, first, using blocks of size 4, the arrangement of people next to each other in each block will be determined, and then a number will be assigned to each block, and 12 blocks will be determined to provide the required number of samples. Then, using the table of random numbers, the sequence of using the blocks will be determined. Entering to each group will be done by the number of selected blocks and the arrangement inside the block, respectively. The number of people in each group will be 23.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Zanjan University of Medical Sciences
Street address
Zanjan University of Medical Sciences, Azadi square
City
Zanjan
Province
Zanjan
Postal code
4513956113
Approval date
2021-06-16, 1400/03/26
Ethics committee reference number
IR.ZUMS.REC.1400.111
Health conditions studied
1
Description of health condition studied
Postpartum depression
ICD-10 code
F53
ICD-10 code description
Puerperal psychosis
Primary outcomes
1
Description
Postpartum depression
Timepoint
Before intervention and four weeks after delivery
Method of measurement
Edinburgh Postpartum Depression Inventory
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Counseling with a positive psychology approach for the intervention group will be held once a week through 8 60-90 minute sessions, and at the end of each session, participants will be given homework.
Category
Other
2
Description
Control group: For the control group, routine pregnancy care will be performed. Finally, after the intervention, if desired, the members of the control group will be provided with a description of counseling sessions.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Comprehensive urban health centers
Full name of responsible person
Samira Esmaeili
Street address
Azadi square
City
Zanjan
Province
Zanjan
Postal code
4513665758
Phone
+98 24 3344 4280
Email
samirasmaeeli71@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Dr Alireza Shoghli
Street address
Zanjan University of Medical Sciences; Azadi Square
City
Zanjan
Province
Zanjan
Postal code
4513956113
Phone
+98 24 4133 8138
Email
shoghli@xums.ac.ir
Grant name
thesis
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Zanjan 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
Zanjan University of Medical Sciences
Full name of responsible person
Samira Esmaeili
Position
Master student of counseling in midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
School of Nursing and Midwifery; Karmandan Boulevard
City
Zanjan
Province
Zanjan
Postal code
4513665758
Phone
+98 24 3344 4280
Email
samirasmaeeli71@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
taraneh emamgholi khooshehchin
Position
faculty
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Staff Boulevard, School of Nursing and Midwifery
City
zanjan
Province
Zanjan
Postal code
4513956113
Phone
+98 24 4133 8138
Email
khoosheh@zums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Samira Esmaeili
Position
Master student of counseling in midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
School of Nursing and Midwifery; Karmandan Boulevard
City
Zanjan
Province
Zanjan
Postal code
4513665758
Phone
+98 24 3344 4280
Email
samirasmaeeli71@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is 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
Title and more details about the data/document
The release schedule is not yet known
When the data will become available and for how long
The release schedule is not yet known
To whom data/document is available
The release schedule is not yet known
Under which criteria data/document could be used
The release schedule is not yet known
From where data/document is obtainable
The release schedule is not yet known
What processes are involved for a request to access data/document