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IRCT20220703055351N1 IRCT 2022-09-02 Arak University of Medical Sciences The effect of Mandala staining in girls with dysmenorrhea The effect of Mandala staining on anxiety, Intensity of pain and dysmenorrhea symptoms in girls with dysmenorrhea 2022-07-05 anticipated 80 Complete https://irct.ir/trial/64601 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In the first step, to create a random sequence or random sequence generation, first, each of the 80 volunteers who meet the criteria for entering the study by randomization using the random block method by statistical software and individually and assigning students in two groups of 40 Intervention and control will be based on even and odd numbers. The second stage of concealment of randomization or Allocation concealment, in this research, according to the allocation of the drawing of the Mandela plan for one group and not doing this for the second group of participants will be studied. In the third stage of randomization or implementation of the process, the person who created the random sequence, the person who examined the participants in terms of entry and exit criteria and enrolled them in the study, and the person who divided the participants into groups is the data allocation, the person who performs the data analysis and the researcher will not know about the group allocation, Blinding description: In the third stage of randomization or implementation of the process, the person who created the random sequence, the person who examined the participants in terms of entry and exit criteria and enrolled them in the study, and the person who divided the participants into groups is the data allocation, the person who performs the data analysis and the researcher will not know about the group allocation. N/A Primary dysmenorrhea. Intervention 1: Intervention group: In the intervention group, during two days before menstruation and 3 days at the beginning of menstruation (5 days in total), they will color a mandala design, which will be provided to them by the researcher at the beginning of the month along with a pack of 6 colored pencils. and this work will continue for two menstrual periods. It is better to paint in the beginning of the morning and after waking up due to higher concentration. In the control group, no intervention is done during one cycle. And in order to achieve the most accurate date of the intervention, the intervention group is asked to write down the exact date of their menstruation one cycle before the start of the intervention and fill the relevant questionnaires immediately after the end of this cycle. Mandala coloring includes circular designs that are used as a tool for meditation and psychological improvement, 10 designs are provided to each participant in the intervention group. Intervention 2: Control group: n the control group, no intervention is performed during one cycle. 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 Mahsa Hosseini
Arak University of Medical Sciences, Basij Square, Sardasht, Arak
Arak Iran (Islamic Republic of) 3848176941 +98 86 3417 3503 smahsahosseini99@gmail.com Arak University of Medical Sciences scientific Fereshteh Farzanazar
Arak University of Medical Sciences, Basij Square, Sardasht, Arak
Arak Iran (Islamic Republic of) 3848176941 +98 86 3417 3505 narenji@arakmu.ac.ir Arak University of Medical Sciences Iran (Islamic Republic of) Female students of Arak universities Having at least 18 years of age 18 years no limit Female Presence of known physical and mental illness Presence of known chronic pelvic disease Surgery in the past three months Use of contraceptive pills The onset of menstrual pain after the age of 20 Irregular menstrual cycles N94.4 Primary dysmenorrhoea N/A N/A Intervention group: In the intervention group, during two days before menstruation and 3 days at the beginning of menstruation (5 days in total), they will color a mandala design, which will be provided to them by the researcher at the beginning of the month along with a pack of 6 colored pencils. and this work will continue for two menstrual periods. It is better to paint in the beginning of the morning and after waking up due to higher concentration. In the control group, no intervention is done during one cycle. And in order to achieve the most accurate date of the intervention, the intervention group is asked to write down the exact date of their menstruation one cycle before the start of the intervention and fill the relevant questionnaires immediately after the end of this cycle. Mandala coloring includes circular designs that are used as a tool for meditation and psychological improvement, 10 designs are provided to each participant in the intervention group. Control group: n the control group, no intervention is performed during one cycle. Anxiety. Timepoint: once before the intervention from the time people entered the study and once after the intervention by the relevant questionnaire in the control and intervention groups. Method of measurement: Spellberger's questionnaire. Intensity of pain. Timepoint: once before the intervention from the time people entered the study and once after the intervention by the relevant questionnaire in the control and intervention groups. Method of measurement: Numerical Pain Scale Questionnaire. Symptoms of dysmenorrhea: In this research, symptoms of dysmenorrhea will be measured using the standard mouse menstrual questionnaire. Timepoint: once before the intervention from the time people entered the study and once after the intervention by the relevant questionnaire in the control and intervention groups. Method of measurement: Mouse menstrual standard questionnaire. Arak University of Medical Sciences Approved 2022-03-06 Ethics committee of Arak University of Medical Sciences Arak University of Medical Sciences, Basij Square, Sardasht, Arak Arak Markazi Iran (Islamic Republic of)