Determining the effect of pregnancy counseling with a cognitive behavioral approach on self-esteem and body image in lactating mothers: A quasi-experimental study
Design
Quasi-experimental study، with parallel groups، randomized Sample size 35 people in each group
Settings and conduct
Health centers of populated and culturally diverse areas of Tabriz
Participants/Inclusion and exclusion criteria
1. Minimum level of secondary education
2. Pregnancy age 25-28 weeks
3. First and second pregnancy
4. Singelton
5. Lack of disease affecting pregnancy, according to one's self (cardiovascular disease, preeclampsia, diabetes, epilepsy, etc.)
6. Not taking medications that affect one's mental health problems (sertraline, venlafaxine, deloxin, nortriptyline, etc.)
7. People with a body image score below 241 based on the MBSRQ questionnaire
8. Individuals with a self-esteem score lower than 25 based on the Rosenberg questionnaire
Exclusion criteria
1. Having a history of severe depression, according to the individual
2. Hemorrhage in the second half of pregnancy
Intervention groups
For the intervention group, Cognitive Behavioral Approach, Body Image Based Cache and Starchen Training, and Self Esteem Based on Practical Guide to Group Cognitive Therapy by Michael Frey for 8 sessions of 60 to 90 minutes weekly.The control group will receive routine pregnancy care.
Main outcome variables
self-esteem، body image
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20110524006582N33
Registration date:2020-08-19, 1399/05/29
Registration timing:registered_while_recruiting
Last update:2020-08-19, 1399/05/29
Update count:0
Registration date
2020-08-19, 1399/05/29
Registrant information
Name
Mahin Kamalifard
Name of organization / entity
Tabriz University of Medical Sciences and Health Services
Country
Iran (Islamic Republic of)
Phone
+98 414796770
Email address
kamalifardm@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-05-21, 1399/03/01
Expected recruitment end date
2020-10-22, 1399/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of counseling with cognitive-behavioral approach (CBT) on self esteem and body image of lactating mothers: A quasi-experimental study
Public title
The effect of counseling on body image and self-esteem
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
At least secondary education
gestational age between 25 to 28 weeks
First or second pregnancy
singelton
No disease affecting pregnancy, according to the individual like(Cardiovascular Diseases،Preeclampsia،Diabetes،Epilepsy...)
Not taking drugs that affect psychological problems, according to the individual like:(Sertraline،Venlafaxine،Deluxin،Nortriptyline...)
Individuals with a body image score lower than 241 based on a Multidimensional Body-Self Relation Questionnaire
Individuals with a self-esteem score below 25 based on the Rosenberg questionnaire
Exclusion criteria:
Having a history of severe depression, according to one's self
Bleeding in the second half of pregnancy
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Participants will be assigned to intervention and control groups using randomized stratified method based on number of pregnancies (Stratification based on first pregnancy and second pregnancy) and size of four and six blocks.
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 Research in Tabriz University of Medical Sciences
Street address
Tabriz University of Medical Sciences Research Administration
City
Tabriz
Province
East Azarbaijan
Postal code
5165665931
Approval date
2020-01-07, 1398/10/17
Ethics committee reference number
IR.TBZMED.REC.1398.1099
Health conditions studied
1
Description of health condition studied
self esteem and body image
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Comparison of the mean score of self esteem among the study groups
Timepoint
Before intervention, immediately after intervention, 1 month after delivery
Method of measurement
Rosenberg Self-esteem Questionnaire
2
Description
Comparison of the mean score of body image among the study groups
Timepoint
Before intervention, immediately after intervention, 1 month after delivery
Method of measurement
Multidimensional Body-Self Relation Questionnaire
Secondary outcomes
1
Description
Comparison of the mean score of exclusive breastfeeding among study groups
Timepoint
1 month after delivery
Method of measurement
Designed exclusively breastfeeding checklist
Intervention groups
1
Description
Intervention group: People who will receive counseling with cognitive behavioral approach
Category
Behavior
2
Description
Control group: People who only will receive routine care.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Health centers of Tabriz
Full name of responsible person
Nasrin Zamiri-Miandoab
Street address
No. Nesferah av,Jahad square,Ghareaghage st
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3479 6770
Email
nasriinzamiri@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mohammad Samiei
Street address
Golgasht Street, Research Office, No 2 Central Building, Tabriz University of Medical Sciences,
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3479 6770
Email
samiei.moh@gmail.com
Grant name
20%Grant active researchers
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Mahin kamalifard
Position
Faculty member
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Shariati Street, Tabriz Nursing Midwifery Faculty
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 34796770
Email
kamalifardm@tbzmed.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mahin Kamalifard
Position
Faculty member
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Shariati Street, Faculty of Nursing Midwifery
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 34796770
Email
kamalifardm@tbzmed.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mahin Kamalifard
Position
Faculty member
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Shariati Street, Tabriz Nursing Midwifery Faculty
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 34796770
Email
kamalifard@tbzmed.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Title and more details about the data/document
Publishing in journals
When the data will become available and for how long
index of journal
To whom data/document is available
all people
Under which criteria data/document could be used
without any provision
From where data/document is obtainable
web page of journal
What processes are involved for a request to access data/document