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Comparing the effectiveness of schema therapy and psychodrama therapy on body image, social isolation, self-esteem, and phantom pain in mastectomy patients in Tehran.

Protocol summary

Study aim
Determining the difference in the effectiveness of schema therapy and psychodramatic therapy on body image, social isolation, self-esteem, and phantom pain in mastectomy patients, Tehran.
Design
60 mastectomy patients were selected through purposive sampling and randomly assigned to three groups of 20. Pre-test, post-test, and follow-up were conducted for all three groups. In the qualitative part, data collection was done through library methods and data analysis was done through analysis of covariance. In the quantitative part, the first experimental group underwent (10 sessions, 90 minutes) emotional schema therapy protocol, and the second experimental group underwent 10 sessions, 90 minutes, psychodrama therapy protocol, and the control group did not receive the intervention and a post-test was administered after the intervention.
Settings and conduct
After random sampling and completion of questionnaires, schema therapy and psychodrama therapy sessions are conducted for the sample at Tehran's Super Specialty Hospital.
Participants/Inclusion and exclusion criteria
Going through a recovery period after mastectomy, no definitive diagnosis of a comorbid mental disorder, no physical illnesses other than breast cancer, informed consent to participate in the research, experiencing a definite diagnosis of a mental or physical illness during the research, occurrence of an incident that had a psychological impact on the subject, and the subject's desire to abandon treatment.
Intervention groups
Three groups: pre-test, post-test, and follow-up. The first experimental group received emotional schema therapy, and the second experimental group received psychodrama therapy, and no intervention was performed in the control group.
Main outcome variables
Schema therapy and psychodramatic therapy will be meaningful on body image, social isolation, self-esteem, and phantom pain of mastectomy patients.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20251128068136N1
Registration date: 2025-12-25, 1404/10/04
Registration timing: prospective

Last update: 2025-12-25, 1404/10/04
Update count: 0
Registration date
2025-12-25, 1404/10/04
Registrant information
Name
Mona Shukri Shams
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3377 8070
Email address
shokri.kia@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-12-30, 1404/10/09
Expected recruitment end date
2026-03-29, 1405/01/09
Actual recruitment start date
2025-12-30, 1404/10/09
Actual recruitment end date
2026-05-20, 1405/02/30
Trial completion date
2026-08-20, 1405/05/29
Scientific title
Comparing the effectiveness of schema therapy and psychodrama therapy on body image, social isolation, self-esteem, and phantom pain in mastectomy patients in Tehran.
Public title
Comparing the effectiveness of schema therapy and psychodrama therapy on body image, social isolation, self-esteem, and phantom pain in mastectomy patients in Tehran.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Recovering from a mastectomy Lack of definitive diagnosis of comorbid mental disorder Not having any other physical illness or disease other than breast cancer. Informed consent to participate in research
Exclusion criteria:
Experiencing a definite diagnosed mental or physical illness during the research An incident or event that has a significant psychological impact on the subject Subject's willingness to abandon treatment
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Actual sample size reached: 60
Randomization (investigator's opinion)
Randomized
Randomization description
تعداد ۶۰ نفر بیماران ماستکتومی ، با استفاده از روش نمونه گیری هدفمند وبر اساس ملاک ها ورود انتخاب خواهند شدو به صورت تصادفی ساده از نوع قرعه کشی، به هر یک از اعضای جامعه آماری یک شماره اختصاص داده می‌شود. سپس، اعداد به صورت تصادفی انتخاب می‌شوند و اعضای متناظر با این اعداد، به عنوان نمونه انتخاب می‌شوندودر دو گروه‌ آزمایش و یک گروه گواه گماردهخواهندشد.(۲۰ نفر در هرگروه)
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
Research Ethics Committee ،Islamic Ahvaz University
Street address
Administrative Complex،First Floor،Islamic Azad University، Ahvaz Branch، Farhang Shahr،Golestan Highway،Ahvaz،Iran
City
Ahvaz
Province
Khouzestan
Postal code
6461821920
Approval date
2025-05-24, 1404/03/03
Ethics committee reference number
IR.IAU.AHVAZ.REC.1404.050

Health conditions studied

1

Description of health condition studied
Comparing the effectiveness of schema therapy and psychodramatic therapy on body image, social isolation, self-esteem, and phantom pain in mastectomy patients in Tehran.
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
The score that the subject will obtain from the Multidimensional Body-Self Relationships Questionnaire will be the body image variable.
Timepoint
Pre-test 7 days, post-test 7 days, intervention 60 days, follow-up 60 days after the post-test.
Method of measurement
Multidimensional Body-Self Relationships Questionnaire (MBSRQ)

2

Description
The score that the subject will obtain from the Chalabi and Amirkafi Social Isolation Questionnaire will be the social isolation variable.
Timepoint
Pre-test 7 days, post-test 7 days, intervention 60 days, follow-up 60 days after the post-test.
Method of measurement
Chalpi and Amirkafi Social Isolation QuestionnaireChalpi and Amirkafi Social Isolation Questionnaire

3

Description
The score that the subject will obtain from the Eysenck Self-Esteem Scale will be the self-esteem variable.
Timepoint
Pre-test 7 days, post-test 7 days, intervention 60 days, follow-up 60 days after the post-test.
Method of measurement
Eysenck Self-Esteem Scale (ESI)

4

Description
The score that the subject will obtain from the Wang Bakker pain scale will be the phantom pain variable.
Timepoint
Pre-test 7 days, post-test 7 days, intervention 60 days, follow-up 60 days after the post-test.
Method of measurement
Vankbacker pain scale

Secondary outcomes

empty

Intervention groups

1

Description
ntervention group: The first intervention group: 1- A pre-test will be given to the intervention group. 2- The second stage will be given to the first intervention group in 20 90-minute sessions. 3- A post-test will be given to the first intervention group. 4- The fourth stage will be a follow-up of the first intervention group after a month.
Category
Treatment - Other

2

Description
Intervention group: Second intervention group: Second intervention group - 1- Pre-test will be taken from the intervention group. 2- The second stage of the second intervention group will be given short-term solution-focused therapy in 8 2-hour sessions. 3- Post-test will be taken from the second intervention group. 4- The fourth stage of follow-up will be done from the two intervention groups after a month.
Category
Treatment - Other

3

Description
Control group: No intervention will be performed.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Laleh Superspecialty Hospital
Full name of responsible person
Dr. Karmaali Basari
Street address
Tehran, Shahrak-e Gharb, South Simaye Iran Street, Laleh Subspecialty Hospital.
City
Tehran
Province
Tehran
Postal code
1467684595
Phone
+98 21 8856 3020
Fax
+98 21 8857 1081
Email
info@laleh-hospital.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mohammad Taghipour Birgani
Street address
First floor office complex،Islamic Azad University of Ahvaz Branch، Farhang Shahr،Golestan Highway،Ahvaz،Iran
City
Ahvaz
Province
Khouzestan
Postal code
6134937333
Phone
+98 61 3334 8420
Fax
+98 61 3334 8336
Email
Parivaladmomen50@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
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
Islamic Azad University
Full name of responsible person
Mona Shukri Shams
Position
Student
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Unit 3, No. 33, Vakili Alley, Mousavi Street، Bagh Moein
City
Ahvaz
Province
Khouzestan
Postal code
6183853965
Phone
+98 61 3379 8699
Email
shokri@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Sayedeh Zahra Alavi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Faculty of Nursing and Midwifery،Islamic Azad University of Ahvaz Branch، Farhang Shahr،Golestan Highway،Ahvaz،Iran
City
Ahvaz
Province
Khouzestan
Postal code
6134937339
Phone
+98 61 3334 8420
Email
Zahraalavi724@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mona Shukri Shams
Position
Student
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Unit 3, No. 33, Vakili Alley, Mousavi Street، Bagh Moein
City
Ahvaz
Province
Khouzestan
Postal code
6134937339
Phone
+98 61 3379 8699
Email
shokri@yahoo.com

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
I will make a decision after completing the research and results.
Study Protocol
No - There is not 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
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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