Evaluate the effect of self-care education based on Teach Back method on the mental health of pregnant mothers
Design
Two arm parallel group randomized trial, will be conducted on 60 pregnant women referred to healthcare centers of Mashhad
Settings and conduct
The eligible women who will refer to healthcare centers of Mashhad,during the study period will be divided into two groups. In Intervention group, Psychological self-care educations based on Group teach back method is provided for groups of 8-10 persons (one session per week for three weeks, during 60 minute.).Training are related to (physical and mental changes in pregnancy, the role of sleep and nutrition and stress on health, signs and symptoms of depression, anxiety, and... ). After completion of training, the subject was asked to say what they understand, in their own words. If the patient has not understood the content of sessions, educator would continue to explain until the patient would fully understand the contents. Then, the patients will be given the opportunity to ask their questions and receive the proper answers.The control group will be received routine training in the health care center. Then, the mental health score in control and intervention groups will be re-evaluated 4 weeks after the training.
Participants/Inclusion and exclusion criteria
Iranian nationality, have the ability to read and write, have the single pregnancy, aged 18 to 45 years,gestational age between 18 to 32 weeks
Intervention groups
Psychological self-care educations based on group teach back method well be provided in one session per week for three weeks.The duration of each class will be 60 minutes. subjects will be divided into groups of 8 to 10 persons .The control group received routine training in the health care center
Main outcome variables
mental health
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170430033717N2
Registration date:2018-11-12, 1397/08/21
Registration timing:prospective
Last update:2018-11-12, 1397/08/21
Update count:0
Registration date
2018-11-12, 1397/08/21
Registrant information
Name
Samaneh Jouya
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 3859 1511
Email address
jouyas941@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-11-18, 1397/08/27
Expected recruitment end date
2019-03-19, 1397/12/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of self-care education based on Teach Back method on the mental health of pregnant mothers
Public title
The effect of training on the mental health of pregnant mothers
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Iranian nationality
Have the ability to read and write
Aged 18 to 45
Single pregnancy
No history of acute or chronic medical condition
Gestational age between 32-28 weeks
Lack of addiction to smoking and alcohol use
Lack of stressful events occurred during the last 3 months
Exclusion criteria:
Not completing at least two educational sessions
No tendency to cooperate with research team
Having history of mental disorders
Have a high risk pregnancy
Age
From 18 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Using a simple random sampling method (random table number), two health centers are selected from five health centers in Mashhad. These centers assigned to the two group of intervention and control groups using coin throw.
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
Ethics committee of Mashhad University of Medical Sciences
Street address
Daneshgah street, Ghoreshi building, Mashhad University of Medical Sciences
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Approval date
2018-10-04, 1397/07/12
Ethics committee reference number
IR.MUMS.NURSE.REC.1397.030
Health conditions studied
1
Description of health condition studied
Mental health of pregnant women
ICD-10 code
F99
ICD-10 code description
Mental disorder, not otherwise specified
Primary outcomes
1
Description
Mental health score
Timepoint
before intervention and 4 weeks after intervention
Method of measurement
Goldberg Health questionnaire (GHQ)
Secondary outcomes
1
Description
spiritual health
Timepoint
Before intervention and 4 weeks after intervention
Method of measurement
spiritual health assessment questionnaire (Paloutzian & Ellison)
2
Description
hope
Timepoint
Before intervention and 4 weeks after intervention
Method of measurement
Snyder's Hope Questionnaire
Intervention groups
1
Description
Intervention group: In intervention group Psychological self-care educations based on Group teach back method is provided for groups of 8-10 persons in each session .each participant takes part in one session per week for 3 weeks. (Each training class lasts for 60 minutes).
Category
Behavior
2
Description
Control group: The control group received routine training in the health care center
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Abas abad Health Center
Full name of responsible person
Dr Asna Ashar
Street address
No. 9th street, Kamyab Blvd.
City
Mashhad
Province
Razavi Khorasan
Postal code
9181111111
Phone
+98 51 3735 8906
Email
Jouyas941@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen tafaghodi
Street address
Daneshgah Ave, Ghoreshi bulding
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
Jouyas941@mums.ac.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Samaneh Jouya
Position
Non-faculty trainer
Latest degree
Master
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Mashhad Nursing Midwifery Faculty, Doktora Crossroads, Ebnecina Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 513768591511
Email
Jouyas941@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Nahid Golmakani
Position
Midwifery Master-Assistant Professor
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Mashhad Nursing Midwifery Faculty, Doktora Crossroads, Ebnesina Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
Golmakanin@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Samaneh Jouya
Position
Non Faculty Trainer
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Mashhad Nursing Midwifery Faculty, Doktora Crossroads, Ebnecina Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3761 8946
Email
Jouyas941@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
No more information
Study Protocol
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available