Determining the effectiveness of cognitive-behavioral counseling on the mind on awareness of dissatisfaction with appearance, on the reason of mindfulness on poor individual performance, on the image of pregnant women
Design
Clinical trial with control group and intervention group and assignment of individuals to each treatment group will be performed by randomized block method using 4 blocks
Settings and conduct
The researcher will refer to the management of comprehensive health centers No.1in the east,Abuzar and west of Ahvaz with the aim of collecting samples
Participants/Inclusion and exclusion criteria
Entry requirements:
1)Being married
2)Being primiparous
3)26 weeks of pregnancy
4)Conscious consent to participate in the study
5)Result of dissatisfaction with appearance in the body image anxiety questionnaire (score above 48)
No entry conditions:
1.Taking medicine or hospitalization due to mental illness during the past year
2.Having major stress (serious illness, spouse or children, death of a loved one, migration, accident, severe family disorders) during the last six months
3.Simultaneous participation in other psychotherapy sessions
Intervention groups
Counseling sessions for the intervention group will be conducted in the form of8sessions of cognitive counseling based on mindfulness by the counseling student in the midwife who has received the necessary certificate.Therapeutic sessions are held once a week for 8weeks and for 45minutes in the conference hall of the client's comprehensive health centers Will be provided from available sources.Routine pregnancy trainings will be performed in the control group
Main outcome variables
1)Mindfulness-based cognitive-behavioral counseling is effective on appearance dissatisfaction and on poor individual performance
2)Mindfulness-based cognitive-behavioral counseling is effective in worrying about body image in pregnant woman
General information
Reason for update
Acronym
-
IRCT registration information
IRCT registration number:IRCT20211218053448N1
Registration date:2022-02-02, 1400/11/13
Registration timing:registered_while_recruiting
Last update:2022-02-02, 1400/11/13
Update count:0
Registration date
2022-02-02, 1400/11/13
Registrant information
Name
Mehnoosh Farahabadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3662 7413
Email address
mehnoosh.farahabadi@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-01-21, 1400/11/01
Expected recruitment end date
2022-06-22, 1401/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of mindfulness-based cognitive counseling on body image concern in pregnant women
Public title
The effect of mindfulness-based cognitive counseling on body image anxiety in pregnant women
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Being married
Being primiparous
26 weeks of pregnancy
Conscious consent to participate in the study
Result of dissatisfaction with appearance in the body image anxiety questionnaire (score above 48)
Exclusion criteria:
1. Taking medication or hospitalization due to mental illness during the past year
Having major stress (serious illness, spouse or children, death of a loved one, migration, accident, severe family disorders) during the last six months
Participate in other psychotherapy sessions at the same time
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Assignment of individuals to each of the treatment groups will be done by random block method and using 4 blocks individually and with a table of random numbers.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
-
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Ahwaz Jundishapur University of Medical Sciences
Street address
Medical Sciences Blvd, Ahvaz Jundishapur University of Medical Sciences, School of Nursing and Midwifery
City
Ahwaz
Province
Khouzestan
Postal code
15794-61357
Approval date
2021-12-11, 1400/09/20
Ethics committee reference number
IR.AJUMS.REC.1400.549
Health conditions studied
1
Description of health condition studied
Concerns about the body image of pregnant women
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Body image concern score on the Littleton questionnaire
Timepoint
Assessing the body image anxiety score of pregnant women at the beginning of the study (before the intervention) and at the end of the intervention (immediately after the intervention)
Method of measurement
Littleton Body Image Concern Questionnaire(BICI)
Secondary outcomes
1
Description
The degree of dissatisfaction with appearance
Timepoint
At the beginning of the study (before the intervention) and immediately after the intervention
Method of measurement
Littleton Body Image Concern Questionnaire (BICI)
2
Description
Poor individual performance
Timepoint
At the beginning of the study (before the intervention) and immediately after the intervention
Method of measurement
Littleton Body Image Concern Questionnaire(BICI)
Intervention groups
1
Description
Intervention group: The sessions will be conducted in the form of 8 sessions of mindfulness-based cognitive counseling by a counseling student in midwifery who has been trained in cognitive-behavioral counseling courses and has received the necessary certification. Therapeutic sessions are held once a week on a specific day of the week, for 8 weeks and for 45 minutes in the conference hall of the client's comprehensive health centers. Consultation sessions will be held in groups due to the coronavirus epidemic with a limited number of people (4 people). The content of cognitive-behavioral therapy in each session will be presented under the supervision of supervisors and counselors and using available resources.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Comprehensive health center number one in East Ahvaz
Full name of responsible person
Zahra Abbaspour
Street address
Ahvaz - Ayatollah Behbahani Highway - Shahid Rastegari St. - Opposite Haft Tir Park - East Ahvaz Health Center
City
Ahwaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 916 234 1532
Email
abbaspoor_z762@yahoo.com
Web page address
http://www.ajums.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Zahra Abaspur
Street address
Medicine Blvd, Jondishapur Ahwaz University
City
Ahwaz
Province
Khouzestan
Postal code
15794-61357
Phone
+98 61 3311 4114
Email
mehnoosh.farahabadi@gmail.com
Web page address
http://www.ajums.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Mehnoosh Farahabdi
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Medicine Blvd,Jondishapur Ahwaz University
City
Ahwaz
Province
Khouzestan
Postal code
15794 - 61357
Phone
+98 61 3311 0000
Email
mehnoosh.farahabadi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mehnoosh Farahabadi
Position
MSc student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
بلوار علوم پزشکی،دانشکده پرستاری و مامایی،دانشگاه جندی شاپور اهواز
City
Ahwaz
Province
Khouzestan
Postal code
15794 - 61357
Phone
33110000- 061
Email
mehnoosh.farahabadi@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mehnoosh Farahabadi
Position
MSc student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Boulevard of Medical Sciences, School of Nursing and Midwifery, Ahvaz Jundishapur University
City
Ahwaz
Province
Khouzestan
Postal code
15794 - 61357
Phone
00980033110000
Email
mehnoosh.farahabadi@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
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All potential data can be shared after identifying individuals
When the data will become available and for how long
Start the access period after printing the results
To whom data/document is available
The data will be made available to people who need to read me
Under which criteria data/document could be used
Documents are allowed to be used with reference to the exact same