Protocol summary

Summary
The purpose of this study is to recognize the effectiveness of cognitive-behavioral group treatment on the negative body image of post menopause women. This is a clinical trail , which is done on the 22 afflicted women with their negative body image. This sampling is done in the Health Center of East Part of Ahvaz and it meaningful trail ,too. Inclusion criteria are: 45 to 60 year-old- women who have passed their menopause in at least two years, who have the literacy, have more than 57 scores in dread of appearance and fitness questionnaire. Exclusion criteria are: The body mass index which is less than 18/5 and more than 30, possessing the malformation and major body faults. Data should be studied based on the questionnaire of self- body dimensional relationships and worry about body image (BI CI).Women who receive the remarkable score, are divided normally into two experimental and control groups. In each group, 11 participants are selected for intervention group in 8 sessions in 90 minutes with counseling of course the cognitive-behavioral group is done by the researcher. After end of consulting, each of two groups are considerate by using the questionnaire which is related to the multidimensional self-body and dread of appearance. The primary outcome of this study is the improvement of body image in post menopause women in the experimental group based on the scores of questionnaire.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017041029964N1
Registration date: 2017-04-10, 1396/01/21
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-04-10, 1396/01/21
Registrant information
Name
Marziye Hosseini
Name of organization / entity
Ahvaz jundishapur university medical of sciense
Country
Iran (Islamic Republic of)
Phone
+98 917 343 6788
Email address
hosseini.m@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Research Department of Medical Science(Jundishapur, Ahvaz)
Expected recruitment start date
2016-11-20, 1395/08/30
Expected recruitment end date
2017-01-19, 1395/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effectiveness of cognitive-behavioral group therapy on negative body image in post menopause women
Public title
The Effectiveness of cognitive-behavioral group therapy on negative body image
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 45 to 60 year-old- women who have passed their menopause in at least two years; who have the literacy; have more than 57 scores in dread of appearance and fitness questionnaire. Exclusion criteria: The body mass index which is less than 18/5 and more than 30; possessing the malformation and major body faults.
Age
From 45 years old to 60 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 22
Randomization (investigator's opinion)
Randomized
Randomization description
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 committe of Ahvaz ( Jundishapur) , the university of medical science
Street address
Ground Floor, Deputyminister of Research and Information Technology University of Medical Sciences, Ahvaz Jundishapour.
City
Ahvaz
Postal code
Approval date
2016-10-25, 1395/08/04
Ethics committee reference number
IR. AJUMS. REC.1395.453

Health conditions studied

1

Description of health condition studied
negative body image
ICD-10 code
F45
ICD-10 code description
Body Dysmorphic Disorder

Primary outcomes

1

Description
Negative body image
Timepoint
Before intervention, immediately after intervention, a month after intervention.
Method of measurement
Multidimensional Body-Self Relations Questionnar ,Body Image Concern Inventory Questionnar

Secondary outcomes

1

Description
Fitness orientation
Timepoint
Before intervention, immediately after intervention, a month after intervention.
Method of measurement
Multidimensional Body-Self Relations Questionnaire

2

Description
Body Image Concern
Timepoint
Before intervention, immediately after intervention, a month after intervention.
Method of measurement
body image concern inventory questionnar

3

Description
Body areas satisfaction
Timepoint
Before intervention, immediately after intervention, a month after intervention.
Method of measurement
Multidimensional Body-Self Relations Questionnaire

4

Description
Fitness evaluation
Timepoint
Before intervention, immediately after intervention, a month after intervention.
Method of measurement
Multidimensional Body-Self Relations Questionnaire

5

Description
Appearance evaluation
Timepoint
Before intervention, immediately after intervention, a month after intervention.
Method of measurement
Multidimensional Body-Self Relations Questionnaire

Intervention groups

1

Description
The intervention is group received eight sessions of cognitive behavioral group therapy. Time of Each session is 90 minutes and has a specific structure.
Category
Behavior

2

Description
The intervention wasn't done on control group, and is ranked in the waiting list.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
The health center of number one East part
Full name of responsible person
Marziyeh Hosseini
Street address
City
Ahvaz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Research Department of medical science (Ahvaz university )
Full name of responsible person
Dr Behzad Sharief Makhmalzade
Street address
Ground Floor, Research department of medical science and Health Services (Jundishapur, Ahvaz )
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Department of medical science (Ahvaz university )
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Ahvaz Jundishapur university of medical science
Full name of responsible person
Marziyeh Hosseini
Position
The master Student of consultation in Midwifery
Other areas of specialty/work
Street address
Ahvaz Jundishapur University of Medical Sciences, College of Nursing and Midwifery Ahvaz
City
Ahvaz
Postal code
75818-45713
Phone
+7 433321161
Fax
Email
marziyehhosseini02@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz Jundishapur university of medical science
Full name of responsible person
Nahid Javadifar
Position
PHD of Reproductive Health
Other areas of specialty/work
Street address
Ahvaz Jundishapur University of Medical Science, College of Nursing and Midwifery Ahva
City
Avaz
Postal code
Phone
+98 916 612 1693
Fax
Email
Nahidjavadifar_341@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz Jundishapur university of medical science
Full name of responsible person
Marziyeh Hosseini
Position
The master student of consultation in Midwifery
Other areas of specialty/work
Street address
Jundishapur university of medical science, Golestan Blv, Ahvaz
City
Ahvaz
Postal code
75818-45713
Phone
+98 917 342 6788
Fax
Email
marziyehhoseeini02@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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