]>
IRCT20250627066274N1 IRCT 2025-08-30 Zabol University of Medical Sciences The effectiveness of art therapy on mental well-being and resilience in major thalassemia patient The effectiveness of art therapy using coloring mandala designs on mental well-being and resilience in major thalassemia patients 2025-08-23 anticipated 80 Complete https://irct.ir/trial/85472 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, 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 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. N/A Major Thalassemia. Intervention 1: 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. Intervention 2: Control group: Patients receive the centers' routine care program. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information.
public Ghadir Harati
No.11 Ferdowsi St, next to Civil Registry Office, Nursing and midwifery school
Zabol Iran (Islamic Republic of) 98616615881 +98 54 3222 3948 ghadir0098@gmail.com Zabol University of Medical Sciences scientific Mahdieh Poodineh moghadam
No.11 Ferdowsi St,next to Civil Registry Office,Nursing and midwifery school
Zabol Iran (Islamic Republic of) 9861734184 +98 54 3222 3947 moghadam07@yahoo.com Zabol University of Medical Sciences Iran (Islamic Republic of) 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 12 years 35 years Both Having thalassemia intermediate proven mental disorder or ongoing treatment Taking psychiatric medications D56.1 Beta thalassemia Lifestyle Lifestyle 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. Control group: Patients receive the centers' routine care program. Mental Well-being. Timepoint: Before the intervention and one week after the intervention. Method of measurement: Keyes and Magyar's Mental Well-Being Questionnaire. Resilience. Timepoint: Before the intervention and one week after the intervention. Method of measurement: Connor-Davidson Resilience Scale. Zabol University of Medical Sciences Approved 2025-07-15 Ethics Committee of Zabol University of Medical Sciences Rajai Street, Research Department of the University Zabol Sistan-va-Balouchestan Iran (Islamic Republic of)