Determining the effectiveness of art therapy through mandala coloring on mental well-being and resilience in patients with major thalassemia in the Sistan region in 2025-2026.
Design
The study is a randomized controlled clinical trial that will be conducted in two intervention and control groups in a single-blind on 80 patients with thalassemia major.
Settings and conduct
The research population consists of thalassemia major patients referred to special thalassemia patient centers in Sistan. The samples are randomly divided into two control and intervention groups, and art therapy sessions are conducted in the intervention group. To prevent information leakage, the control group is asked not to ask the intervention group any questions about the project until the end of the intervention, and after the project is completed, the necessary information is provided to them.
Participants/Inclusion and exclusion criteria
1) Confirmed diagnosis of major thalassemia by a specialist.
2) Age between 12 and 35 years
3) Physical health and visual acuity.
Exclusion criteria:
1) Having thalassemia intermediate
2) proven mental disorder or ongoing treatment
3)Taking psychiatric medications
Intervention groups
In the intervention group, the intervention will be carried out over ten sessions by a specialist mandala designs. In the intervention group, the art therapy protocol will be as follows: intervention sessions will be 30 to 45 minutes once or twice a week, derived from the Labadi and Ronaghi protocol (2009) and using Albert Hutchinson's book, including teaching a set of coloring different mandala designs, which will be divided into easy, medium, and difficult based on the number of sessions. After these sessions, questionnaires will be completed, and the control group will only receive routine care from the treatment center
Main outcome variables
Mental well-being, resilience
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20250627066274N1
Registration date:2025-08-30, 1404/06/08
Registration timing:registered_while_recruiting
Last update:2025-08-30, 1404/06/08
Update count:0
Registration date
2025-08-30, 1404/06/08
Registrant information
Name
ghadir harati
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 54 3222 2222
Email address
ghadir0098@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-08-23, 1404/06/01
Expected recruitment end date
2026-02-20, 1404/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of art therapy using coloring mandala designs on mental well-being and resilience in major thalassemia patients
Public title
The effectiveness of art therapy on mental well-being and resilience in major thalassemia patient
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Confirmed diagnosis of major thalassemia by a specialist
Age between 12 and 35 years
Minimum literacy in reading and writing
No use of any psychological interventions or counseling during the periods when participants are undergoing this intervention
Proficiency in the Persian language
Consent to participate in the specified courses
Physical health and visual acuity
Exclusion criteria:
Having thalassemia intermediate
proven mental disorder or ongoing treatment
Taking psychiatric medications
Age
From 12 years old to 35 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization process will involve shuffling cards or envelopes. In this method, a number of cards will be selected by the researcher for the first group, and the same number of cards will be designated for the second group. Then, by merging the cards together (shuffling the cards), one card will be drawn, and its allocation will be recorded. After being drawn, that card will be returned to the pool of remaining cards. The cards will then be merged again, and another card will be drawn. This process will continue until a random sequence is achieved that corresponds to the sample size.
To conceal the random allocation, opaque, sealed envelopes containing the random sequence will be used.
Blinding (investigator's opinion)
Single blinded
Blinding description
In order to prevent information leakage, the control group is requested not to ask the intervention group questions about the project until the end of the intervention, and after the completion of the project, the necessary information will be provided to them.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Zabol University of Medical Sciences
Street address
Rajai Street, Research Department of the University
City
Zabol
Province
Sistan-va-Balouchestan
Postal code
9861734184
Approval date
2025-07-15, 1404/04/24
Ethics committee reference number
IR.ZBMU.REC.1404.060
Health conditions studied
1
Description of health condition studied
Major Thalassemia
ICD-10 code
D56.1
ICD-10 code description
Beta thalassemia
Primary outcomes
1
Description
Mental Well-being
Timepoint
Before the intervention and one week after the intervention.
Method of measurement
Keyes and Magyar's Mental Well-Being Questionnaire
2
Description
Resilience
Timepoint
Before the intervention and one week after the intervention.
Method of measurement
Connor-Davidson Resilience Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Intervention sessions will be conducted over ten sessions by an expert familiar with mandala designs (having a university education in psychology, teaching experience, and clinical experience) and a qualified facilitator (master's student, clinical experience). In the intervention group, the art therapy protocol will be as follows: intervention sessions will last 30 to 45 minutes once or twice a week, derived from the Labadi and Ronaghi protocol (2009) and using Albert Hutchinson's book, including teaching a set of coloring different mandala designs, which will be divided into easy, medium, and difficult based on the number of sessions.
Category
Lifestyle
2
Description
Control group: Patients receive the centers' routine care program.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Thalassemia departments of Sistan region
Full name of responsible person
Sara Rashki Ghaleno
Street address
No 16-17 Motahari , Motahari Street, Zabol Town
City
Zabol
Province
Sistan-va-Balouchestan
Postal code
9861663335
Phone
+98 54 3222 5402
Email
info@zbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zabol University of Medical Sciences
Full name of responsible person
Dr. Abdolhossein Miri
Street address
Rejaee street
City
Zabol
Province
Sistan-va-Balouchestan
Postal code
98616615881
Phone
+98 54 3223 0768
Email
Research@zbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zabol 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
Zabol University of Medical Sciences
Full name of responsible person
Ghadir Harati
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No.11 Ferdowsi St, next to Civil Registry Office, Nursing and midwifery school
City
Zabol
Province
Sistan-va-Balouchestan
Postal code
98616615881
Phone
+98 54 3222 3948
Email
ghadir0098@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zabol University of Medical Sciences
Full name of responsible person
Mahdieh Poodineh moghadam
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
No.11 Ferdowsi St,next to Civil Registry Office,Nursing and midwifery school
City
Zabol
Province
Sistan-va-Balouchestan
Postal code
9861734184
Phone
+98 54 3222 3947
Email
moghadam07@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Zabol University of Medical Sciences
Full name of responsible person
Ghadir Harati
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No.11 Ferdowsi St, next to Civil Registry Office, Nursing and midwifery school,
City
zabol
Province
Sistan-va-Balouchestan
Postal code
9861734184
Phone
+98 54 3222 3948
Email
ghadir0098@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available