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IRCT20100211003329N7 IRCT 2021-08-12 Kashan University of Medical Sciences The effect of Uriculotherapy on sleep quality in children with Attention Deficit- Hyperactivity Disorder (ADHD) The effect of Uriculotherapy on sleep quality in children with Attention Deficit- Hyperactivity Disorder (ADHD) 2021-09-23 anticipated 52 Complete https://irct.ir/trial/57439 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Eligible samples will be assigned to each of the two intervention and comparison groups in the form of block randomization. 52 samples were entered into Sealed Envelope Ltd. software. 2017 through www.sealedenvelope.com. The size of the blocks was chosen unequally so that the person entering the samples into the groups could not guess the next sample group, actually it was defined for the software to divide people into two groups in the form of blocks with sizes 4, 6 and 8. The software defined 1 block of 4, 3 blocks of 8 and 4 blocks of 6, Blinding description: The lead researcher places therapeutic or placebo sides on the participants' ears, and the research's colleague, who is unaware of the nature of the sides, performs further evaluations. Participants also have already been told that their sides may be therapeutic or placebo. N/A Attention deficit- hyperactivity disorder. Intervention 1: Intervention group: In this group, Korean-made DONG BANG brand Vakaria sidewalls are glued by the researcher on Shenman, sympathetic, sub cortex, heart and endocrine points that are related to sleep quality. The mother and child will be instructed to press these sidewalls each time for three minutes with the index finger and thumb by the child (under the supervision of an adult) or a relative. During the 4 weeks of the intervention, the labels will be affixed by the researcher alternately on both ears every other week. The labels are placed on the ear for five days each week and the mother is instructed to remove them by the end of the fifth day to prevent possible allergic reactions. It is also noted that if the labels are removed during the five-day period, the researcher will be notified by telephone; In that case, the researcher will re-affix the labels with the consent of the family at their home, in the Karegarnejad hospital or wherever it is convenient for the family. The method of pressing the sidewalls will be taught to the intervention group by the researcher; In addition, during the intervention, a weekly diary will be provided to mothers, in which mothers will record possible allergic reactions, hypnotic use, frequency and duration of each pressure. Every week, all participants will be visited at the agreed location and new stickers will be affixed to them; A daily note sheet will be delivered to them and another sheet will be delivered to them next week. The information in the diaries is analyzed every week, and if the average number of times of pressure and the duration of each time of pressure on the sides is at least 2 times a day and 2 minutes each time, the sample will remain in the study. Labeling will continue for 4 weeks and samples will be followed up for 4 weeks after the intervention. In addition to starting the study, the CSHQ questionnaire will be completed after the intervention (end of the fourth week) and 4 weeks after the intervention (end of the eighth week) through face-to-face interviews with the mother by the research Fellow (who does not know how to divide the samples into two groups). Intervention 2: Control group: Auriculotherapy will be performed for 4 weeks, five days a week, three times a day and one hour before bedtime. In this group, Vakaria brand DONG BANG brand made in Korea on shenman, sympathetic, subcortex, heart and endocrine points that are related to sleep quality. Only the seedless label will be affixed to the points and no pressure will be applied to the points. It should be noted that during the 4 weeks of intervention, the labels will be affixed by the researcher alternately on both ears every other week. The labels are placed on the ear for five days each week and the mother is instructed to remove them at the end of the fifth day to prevent possible allergic reactions; It is also noted that if the labels are removed during the five-day period, the researcher will be notified by telephone; In that case, the researcher will re-affix the labels with the consent of the family at their home, in the Karegarnejad hospital or wherever it is convenient for the family. No - There is not a plan to make this available Justification or reason for not sharing IPD is Not done yet
public Zahra Tagharobi
Kashan. Qutb Ravandi Blvd., Pezeshk Blvd., Kashan University of Medical Sciences
Kashan Iran (Islamic Republic of) 8715981151 +98 31 5558 9021 tagharrobi_z@yahoo.com Kashan University of Medical Sciences scientific Zahra Tagharrobi
Kashan. Qutb Ravandi Blvd., Pezeshk Blvd., Kashan University of Medical Sciences
Kashan Iran (Islamic Republic of) 8715981151 +98 31 5558 9021 tagharrobi_z@yahoo.com Kashan University of Medical Sciences Iran (Islamic Republic of) Age 6 to 11 years Suffering from Attention Deficit- Hyperactivity Disorder (ADHD) based on the diagnosis of pediatric psychiatrist according to DSM-5 criteria Get a score of 41 or higher ( based on the CSHQ tools) Organ health in the earlobe area Medicated for ADHD Resident in Kashan Iranian citizenship Living with both parent Willing of mother and child to participate in the study 6 years 11 years Both Exposure to acute and severe stress Acute serious illness, hospitalization, lack of access Concomitant use of other non-pharmacological methods Exposure to severe crises from 3 months prior to study Change in medication schedule for at least two weeks before the start of the study Simultaneous known psychiatric disorders and mental retardation Known chronic diseases (heart, respiratory, glandular and allergies diseases) Using sleeping pills Suffering from blindness and deafness F90.0 Attention-deficit hyperactivity disorder, predominantly inattentive type Treatment - Drugs Placebo Intervention group: In this group, Korean-made DONG BANG brand Vakaria sidewalls are glued by the researcher on Shenman, sympathetic, sub cortex, heart and endocrine points that are related to sleep quality. The mother and child will be instructed to press these sidewalls each time for three minutes with the index finger and thumb by the child (under the supervision of an adult) or a relative. During the 4 weeks of the intervention, the labels will be affixed by the researcher alternately on both ears every other week. The labels are placed on the ear for five days each week and the mother is instructed to remove them by the end of the fifth day to prevent possible allergic reactions. It is also noted that if the labels are removed during the five-day period, the researcher will be notified by telephone; In that case, the researcher will re-affix the labels with the consent of the family at their home, in the Karegarnejad hospital or wherever it is convenient for the family. The method of pressing the sidewalls will be taught to the intervention group by the researcher; In addition, during the intervention, a weekly diary will be provided to mothers, in which mothers will record possible allergic reactions, hypnotic use, frequency and duration of each pressure. Every week, all participants will be visited at the agreed location and new stickers will be affixed to them; A daily note sheet will be delivered to them and another sheet will be delivered to them next week. The information in the diaries is analyzed every week, and if the average number of times of pressure and the duration of each time of pressure on the sides is at least 2 times a day and 2 minutes each time, the sample will remain in the study. Labeling will continue for 4 weeks and samples will be followed up for 4 weeks after the intervention. In addition to starting the study, the CSHQ questionnaire will be completed after the intervention (end of the fourth week) and 4 weeks after the intervention (end of the eighth week) through face-to-face interviews with the mother by the research Fellow (who does not know how to divide the samples into two groups). Control group: Auriculotherapy will be performed for 4 weeks, five days a week, three times a day and one hour before bedtime. In this group, Vakaria brand DONG BANG brand made in Korea on shenman, sympathetic, subcortex, heart and endocrine points that are related to sleep quality. Only the seedless label will be affixed to the points and no pressure will be applied to the points. It should be noted that during the 4 weeks of intervention, the labels will be affixed by the researcher alternately on both ears every other week. The labels are placed on the ear for five days each week and the mother is instructed to remove them at the end of the fifth day to prevent possible allergic reactions; It is also noted that if the labels are removed during the five-day period, the researcher will be notified by telephone; In that case, the researcher will re-affix the labels with the consent of the family at their home, in the Karegarnejad hospital or wherever it is convenient for the family. Sleep quality score. Timepoint: Before the intervention, 4 weeks after the beginning of the intervention, 4 weeks after the end of the intervention. Method of measurement: Children's Sleep Habits Questionnaire. Allergy to sidewalls. Timepoint: Weekely. Method of measurement: Report of mother. Kashan University of Medical Sciences Approved 2021-06-26 Ethics Committee of Kashan University of Medical Sciences Kashan. Qutb Ravandi Blvd., Pezeshk Blvd., Kashan University of Medical Sciences kashan Isfehan Iran (Islamic Republic of)