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IRCT20231126060181N1 IRCT 2024-02-03 Arak University of Medical Sciences The effect of Manda staining on biopsy pain and anxiety The effect of mandala coloring on anxiety and pain in patients undergoing bone marrow biopsy 2024-01-05 anticipated 80 Complete https://irct.ir/trial/74813 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Other design features: In this study, people are divided into control and intervention groups, in the intervention group, people receive a type of intervention, and at the end, the control and intervention groups will be compared, Randomization description: In this study, block randomization method is used to make sure that exactly equal number of participants enter the intervention and control groups in consecutive time intervals. The process of randomly dividing participants into different groups is called block randomization. Randomization gives every participant an equal chance to be placed in each of the groups. 4 blocks including 2 participants in the intervention group (B) and 2 participants in the control group (A) have been used, based on the sequence of entry and according to the block pattern that is randomly selected among the blocks AABB, ABBA, ABAB, BABA, BAAB are selected and assigned to intervention and control groups. N/A Pain and anxiety. Intervention 1: Intervention group: The only intervention performed in this group consists of coloring the same pattern copied in patients undergoing bone marrow sampling with 6-color ink made in Iran, for 30 minutes before the start of bone marrow sampling. Intervention 2: "Control group:" No intervention is done in this group. Yes - There is a plan to make this available What will be shared: All data can potentially be shared after de-identifying individuals. When: The access period starts 6 months after the results are published. To whom: The data is accessible to all researchers. Conditions: There are no conditions for using the data. Where to obtain: To the researcher named Fatemeh Hasani with email address f.hasani@arakmu.ac.ir How to obtain: Almost two months Comments:
public Fatemeh Hasani
Yas Alley ,Jahangiri Street ,Imam Street
Arak Iran (Islamic Republic of) 3816637677 009886344772242 f.hasani@arakmu.ac.ir Arak University of Medical Sciences scientific Fatemeh Hasani
Yas Alley , Jahangiri Street ,Imam Street
Arak Iran (Islamic Republic of) 3816637677 +98 86 3477 2242 f.hasani@arakmu.ac.ir Arak University of Medical Sciences Iran (Islamic Republic of) Willingness to participate in research. Be in the age range of 18 to 45 years. To undergo bone marrow sampling for the first time. Based on the Spielberger anxiety questionnaire, the research unit has mild or moderate anxiety. To treat pain and anxiety, they have not taken medicine or are not undergoing therapeutic intervention. Bone marrow sampling of the research units should be performed by a single physician. Sampling is done from the iliac region. 18 years 45 years Both Unwillingness to participating in the intervention Receiving painkillers and anti-anxiety drugs Being under 18 years old or over 45 years old Lack of mental health F45.4 Persistent somatoform pain disorder N/A N/A Intervention group: The only intervention performed in this group consists of coloring the same pattern copied in patients undergoing bone marrow sampling with 6-color ink made in Iran, for 30 minutes before the start of bone marrow sampling. "Control group:" No intervention is done in this group. The anxiety score of the people is from the Spielberger questionnaire, which will be measured before the intervention, after the intervention, and after sampling. Timepoint: Before intervention and ten minutes after sampling. Method of measurement: Spielberger anxiety questionnaire. Pain score of patients. Timepoint: بعد از نمونه برداری مغز استخوان. Method of measurement: Numerical pain rating scale. Arak University of Medical Sciences Approved 2023-12-03 Ethics committee of arak University of Medical Sciences Yas Alley، Jahangiri Street ،Imam Street arak Markazi Iran (Islamic Republic of)