Determining the effect of group counseling based on acceptance and commitment treatment on body image and self-esteem in poly cystic ovary syndrome patients
Design
A randomized clinical trial with two groups of test and control (waiting), with 48 subjects as sample size, a purpose-based sampling method and dividing subjects into two groups of test and control (waiting)
Settings and conduct
The site of the study is diabetes research center and specialty clinic Khatam-ol-Anbia in Yazd.
Participants/Inclusion and exclusion criteria
The inclusion criteria for this research will be:
Women with poly cystic ovarian syndrome according to Rotterdam criteria and specialist's diagnosis
Iranian and resident of Yazd city
At the age of 45-20 years
The exclude criteria for this research will be:
Patients with known psychological problems such as depression who are under the care of a mental health specialist
Individuals who have had whole-body laser hair removal
Current enrollment in other counseling programs effective on the mind
Intervention groups
After doing a pre-test in persons entered into the study, a group counseling session based on the acceptance and commitment therapy will be held weekly and each session for 90 minutes for the test group. The control group (waiting) will not receive any intervention. After the consultation sessions based on acceptance and commitment treatment, the post-test will be performed again for the subjects in the two groups. After a month after the end of treatment and counseling sessions in the test group, follow-up tests will be performed again for the subjects in the two groups.
Main outcome variables
Acceptance and commitment therapy can be used to improve the body image and self-esteem of patients with PCOS in gynecologic clinics.
General information
Reason for update
Acronym
PCOS
IRCT registration information
IRCT registration number:IRCT20180509039590N1
Registration date:2018-06-24, 1397/04/03
Registration timing:registered_while_recruiting
Last update:2018-06-24, 1397/04/03
Update count:1
Registration date
2018-06-24, 1397/04/03
Registrant information
Name
Fatemeh Moradi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3775 0863
Email address
f.moradi@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-06-22, 1397/04/01
Expected recruitment end date
2019-04-21, 1398/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Group Counseling Based on Commitment and Acceptance Therapy on Body Image and Self-esteem in Patient with Poly Cystic Ovary Syndrome
Public title
Effect of Group Counseling Based on Commitment and Acceptance Therapy on Body Image and Self-esteem in Patient with Poly Cystic Ovary Syndrome
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Women with poly cystic ovarian syndrome according to Rotterdam criteria and specialist's diagnosis
Iranian and resident of Yazd city
At the age of 45-20 years
Exclusion criteria:
Patients with known psychological problems such as depression who are under the care of a mental health specialist
Individuals who have had whole body laser hair removal
Current enrollment in other counseling programs effective on the mind
Age
From 20 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
48
Randomization (investigator's opinion)
Randomized
Randomization description
Patients with PCOS who have inclusion criteria and tend to participate in this study will be entered to study, then the samples will be randomly assigned to the test and control (Waiting) groups.
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 Shahid Sadoughi University of Medical Sciences
Street address
Central building of Shahid Sadoughi University of Medical Sciences of Yazd, Bahonar Square
City
Yazd
Province
Yazd
Postal code
8916189165
Approval date
2018-04-25, 1397/02/05
Ethics committee reference number
IR.SSU.REC.1397.004
Health conditions studied
1
Description of health condition studied
polycystic ovarian syndrome
ICD-10 code
E28.2
ICD-10 code description
Polycystic ovarian syndrome
Primary outcomes
1
Description
The Mean of Body Image Score in Body Image Concern Inventory
Timepoint
The measurement of mean of the body image before the intervention, immediately after the intervention and one month after the end of the intervention.
Method of measurement
Body Image Concern Inventory
2
Description
Mean Score of Self-Esteem in Rosenberg Self-Esteem Questionnaire
Timepoint
The measurement of mean of the self-esteem before the intervention, immediately after the intervention and one month after the end of the intervention.
Method of measurement
Rosenberg Self-Esteem Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The test group will receive 8 sessions of group counseling based on acceptance and commitment treatment weekly and each session for 90 minutes.
Category
Treatment - Other
2
Description
Control group: The control group will not receive any intervention.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Diabetes reserch center
Full name of responsible person
Fatemeh Moradi
Street address
Shahid Sadoughi Blvd, Ba honar Square
City
Yazd
Province
Yazd
Postal code
8916877443
Phone
+98 35 3824 1751
Email
f.moradi@ssu.ac.ir
2
Recruitment center
Name of recruitment center
Specialty Clinic Khatam Al Anbia
Full name of responsible person
Fatemeh Moradi
Street address
Taleghani Blvd, next to the Central Lab
City
Yazd
Province
Yazd
Postal code
8916877443
Phone
+98 35 3824 1751
Email
f.moradi@ssu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Masoud Mirzaei
Street address
Central building of Shahid Sadoughi University of Medical Sciences of Yazd, Bahonar Square
City
Yazd
Province
Yazd
Postal code
8916189165
Phone
+98 35 3726 3733
Email
info@ssu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?