The impact of mindfulness-based compassion therapy on self-criticism and body image in married women
Design
This is a clinical trial . 30 samples were selected through convenience sampling and randomly assigned to intervention and control groups using online randomization software
Settings and conduct
Permission for sampling is granted through visits to Seyed al-Shohada Hospital. After obtaining consent, they are divided into two groups of 15 each. All participants complete questionnaires assessing levels of self-criticism and body image perceptions.
Participants/Inclusion and exclusion criteria
Aged 18-60 with breast cancer, at least three months post-diagnosis, receiving treatment, physically and mentally capable of participating, digitally literate, willing to join, free from psychiatric illnesses or relevant medications.
Intervention groups
The intervention group: eight sessions of Gilbert Mindfulness-Based Compassion Therapy
The control group: no intervention.
Main outcome variables
Mindfulness-based compassion therapy can positively affect self-criticism and body image in women facing the challenges of breast cancer.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20251021067705N1
Registration date:2025-10-30, 1404/08/08
Registration timing:prospective
Last update:2025-10-30, 1404/08/08
Update count:0
Registration date
2025-10-30, 1404/08/08
Registrant information
Name
Maryam Moghimian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 913 114 3254
Email address
maryam.moghimian@iau.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-11-06, 1404/08/15
Expected recruitment end date
2025-11-27, 1404/09/06
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Mindfulness-Based Compassion Therapy on Self-Criticism and Body Image in Women with Breast Cancer
Public title
The Effect of Mindfulness-Based Compassion Therapy on Self-Criticism and Body Image in Women with Breast Cancer
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Married women aged 18-60 years, with a definitive diagnosis of breast cancer, that has been free of symptoms for at least three months since their diagnosis, and the diagnosis crisis has passed
Receiving treatments such as chemotherapy, radiotherapy, drug therapy, and surgery
Physically and mentally able to participate in the study according to the patient's self-declaration
Digital literacy and access to public virtual meeting rooms
Willingness to participate in the study
Permission from the patient's physician/psychologist to participate in the research
Exclusion criteria:
Suffering from specific psychiatric illnesses
Taking specific psychiatric medications according to their self-declaration.
Age
From 18 years old to 60 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
30 women with breast cancer who met the inclusion criteria for the study were selected using a convenience method and were assigned equally to two intervention and control groups using online random software. First, each patient was given a number, then the software was asked to randomly assign numbers 1-30 to two groups (Group 1: Intervention and Group 2: Control). Accordingly, patients assigned to the aforementioned numbers will be assigned to the two intervention and control groups.
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 Islamic Azad University, Najafabad Branch
Street address
نجف اباد، دانشگاه ازاد اسلامی واحد نجف اباد، گروه پرستاری
City
Isfahan
Province
Isfehan
Postal code
۸۵۱۴۱۴۳۱۳۱
Approval date
2025-06-26, 1404/04/05
Ethics committee reference number
IR.IAU.NAJAFABAD.REC.1404.086
Health conditions studied
1
Description of health condition studied
Breast cancer
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Self-criticism and body image
Timepoint
Before and immediately after the study
Method of measurement
Questionnaires for levels of self-criticism and multidimensional relationships with one's own body
Secondary outcomes
empty
Intervention groups
1
Description
The intervention group will receive mindfulness-based compassion therapy intervention based on Gilbert’s compassion therapy protocol in 8 weekly one-hour online group sessions. Each session will include training in mindfulness concepts and practical exercises to reduce self-criticism and improve body image. Interactive lectures, group discussions, and questions and answers will be used to deliver the training. At the end of each session, home exercises will be provided, and at the beginning of the next session, the exercises will be reviewed, and questions will be answered.
Category
Rehabilitation
2
Description
The control group receives routine hospital procedures.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Seyed Al-Shohada Hospital, Isfahan
Full name of responsible person
Yeganeh Mokhtari
Street address
Isfahan, Motahhari Street
City
Isfahan
Province
Isfehan
Postal code
8184917354
Phone
+98 913 905 2743
Email
irathkomhenagey@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Maryam Moghimian
Street address
Daneshgah
City
Najafabad
Province
Isfehan
Postal code
۸۵۱۴۱۴۳۱۳۱
Phone
+98 31 4229 2929
Email
maryam.moghimian@iau.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Thesis
Proportion provided by this source
100
Public or private sector
Private
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
maryam Moghimian
Position
Faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Shariati
City
Isfahan
Province
Isfehan
Postal code
8173815141
Phone
+98 31 3626 4344
Email
maryam.moghimian@iau.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Maryam moghimian
Position
Faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
shariati
City
Isfahan
Province
Isfehan
Postal code
8173815141
Phone
+98 31 3626 4344
Email
maryam.moghimian@iau.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
maryam moghimian
Position
Faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
shariati
City
Isfahan
Province
Isfehan
Postal code
8173815141
Phone
+98 31 3626 4344
Email
maryam.moghimian@iau.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
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
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
All data is potentially shareable after de-identifying individuals.
When the data will become available and for how long
Immediately after printing the results
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
Reference to the results of this study
From where data/document is obtainable
By email to the scientific correspondent of the study, Maryam Moghimian, maryam.moghimian@iau.ac.ir
What processes are involved for a request to access data/document
Submit a request via email, introduce yourself, introduce your study, explain the reason for the request and how the data will be used, and commit to referencing the current study.