Clinical Trial Protocol Iranian Registry of Clinical Trials

01 Oct 2021

Comparison of efficacy of auricular acupuncture with a control group in childhood with Attention-deficit/hyperactivity disorder

Protocol summary Registration date 2019-09-30, 1398/07/08 Study aim Comparison of the effect of auricular acupuncture with Registrant information the control group in children with ADHD Name Design Fataneh Hashem Dabaghian In this phase 1-2 single blinde randomized clinical trial, Name of organization / entity Research Institute for Islamic and Complementary 30 children are randomly assigned to intervention and Medicine control groups. Intervention is performed 4 times with an Country interval of 1 week. (Islamic Republic of) Settings and conduct Phone The study setting is the childcare centers is affiliated +98 21 3395 0152 with the Welfare Organization. Blindness is only Email address done for patients. [email protected] Participants/Inclusion and exclusion criteria Inclusion criteria: 6-14-year-old children with ADHD Non- Recruitment status inclusion criteria: the history of epilepsy; schizophrenia; Recruitment complete mental retardation (IQ less than 70); active depression; Funding source autism. Intervention groups Expected recruitment start date Intervention group1: ٍAuricular acupuncture with 2019-07-23, 1398/05/01 electrical stimulation. Intervention group 2: The seeds Expected recruitment end date are placed on the ear on non-acupuncture points and are 2020-02-20, 1398/12/01 not stimulated. Actual recruitment start date Main outcome variables empty Symptoms severity was assessed using the Conners and Actual recruitment end date CSI questionnaire; Changes in the symptoms of illness empty from the point of view of teachers. Trial completion date empty General information Scientific title Reason for update Comparison of efficacy of auricular acupuncture with a Acronym control group in childhood with Attention- IRCT registration information deficit/hyperactivity disorder IRCT registration number: IRCT20090527001957N9 Registration date: 2019-09-30, 1398/07/08 Public title Registration timing: registered_while_recruiting auriculotherapy and ADHD Purpose Treatment Last update: 2019-09-30, 1398/07/08 Inclusion/Exclusion criteria Update count: 0 Inclusion criteria:

1 age 6-14 years diagnosis of ADHD based on DSM- V Tehran criteria informed consent of patients or their parents If Postal code medication, education, occupational and psychological ۱۴۴۹۶۱۴۵۳۵ therapy are used, there has been no change in drug Approval date dosage or treatment or symptoms of ADHD for at least 2018-10-28, 1397/08/06 the past 2 weeks. Ethics committee reference number Exclusion criteria: IR.IUMS.REC.1397.579 History of epilepsy schizophrenia neurological disorders any psychological disorder requires medication Health conditions studied hyperthyroidism Age From 6 years old to 14 years old 1 Gender Description of health condition studied Both attention deficit hyperactivity disorder ICD-10 code Phase F90 1-2 ICD-10 code description Groups that have been masked Attention-deficit hyperactivity disorders Participant

Sample size Primary outcomes Target sample size: 30 Randomization (investigator's opinion) 1 Randomized Randomization description Description A list is generated using a random number table and severity of ADHD disorder intervention A and B are assigned one by one. Sealed Timepoint envelopes are used for allocation concealment, with the 1 and 3 weeks after intervention patient number on the envelope and the name of the Method of measurement intervention group inside the envelope. Caner's and CSI questionnaire Blinding (investigator's opinion) Single blinded Secondary outcomes Blinding description In the intervention group, acupuncture seeds are placed 1 at the acupuncture point of the ear and electrical stimulation is performed. In the control group, the seeds Description are placed on the non-acupuncture point on ear and no changes of the disease severity from the viewpoint of stimulation is performed. Patients are unaware of the teachers type of interventions. Timepoint Placebo 3 weeks after intervention Used Method of measurement Assignment symptom severity checklist Parallel Other design features Intervention groups

Secondary Ids 1 empty Description Intervention group: Acupuncture seeds are placed at the Ethics committees specific site of the disease and electrical stimulation is performed once a week for 4 weeks. In case of falling 1 seed, stimulation is done twice a week. Category Ethics committee Treatment - Other Name of ethics committee Iran University of Medical Sciences Street address 2 Iran University of Medical Sciences, next to Milad Description tower, Himmat highway Control group: Acupuncture seeds are attached to non- City acupuncture points on the ear and no electrical Tehran stimulation is performed. Province Category

2 Treatment - Other Email [email protected] Recruitment centers 4 1 Recruitment center Name of recruitment center Recruitment center Bonyade Kosar Name of recruitment center Full name of responsible person Balandegan Adham center Batul Sarlak Full name of responsible person Street address Tayebeh Aghahoseini NO: 44, St., Ahmadi St., Shahid Ebrahimi Street address St., Ave. NO: 11, Agahi St., Dabestan Ave., City City Tehran Tehran Province Province Tehran Tehran Postal code Postal code 1983833351 1631766411 Phone Phone +98 21 2236 2890 +98 21 8846 9624 Email Email [email protected] [email protected] Sponsors / Funding sources 2 Recruitment center 1 Name of recruitment center Shahid Ghodoosi center Sponsor Full name of responsible person Name of organization / entity Jamileh Soofi Research Institute for Islamic and Complementary Street address Medicine No: 14, Baradaran Tabrizi St., Yaser crossroad, Full name of responsible person St. Ali Ghobadi City Street address Tehran No: 9, Pirnia alley, Lalehzar-no St., Ave. Province City Tehran Tehran Postal code Province 1976745936 Tehran Phone Postal code +98 21 2270 9012 1145847311 Email Phone [email protected] +98 21 3395 0154 Email [email protected] 3 Grant name Recruitment center Grant code / Reference number Name of recruitment center Is the source of funding the same sponsor Zanjire Mehr Mandegar organization/entity? Full name of responsible person Yes Mohammad Pahlevan Title of funding source Street address Research Institute for Islamic and Complementary No: 36, Taher St., North Majidieh Ave. Medicine City Proportion provided by this source Tehran 100 Province Public or private sector Tehran Public Postal code Domestic or foreign origin 1032084981 Domestic Phone Category of foreign source of funding +98 21 8281 8056 empty

3 Country of origin Contact Type of organization providing the funding Name of organization / entity Academic Research Institute for Islamic and Complementary Medicine Person responsible for general inquiries Full name of responsible person Fataneh Hashem-Dabaghian Contact Position Name of organization / entity Associate professor Iran University of Medical Sciences Latest degree Full name of responsible person Specialist Fataneh Hashem-Dabaghian Other areas of specialty/work Position Others Associate professor Street address Latest degree No: 9, Pirnia alley, Lalehzar-no St., Jomhuri Ave. Specialist City Other areas of specialty/work Tehran Others Province Street address Tehran No: 9, Pirnia alley, Lalehzar-no St., Jomhuri Ave. Postal code City 1145847311 Tehran Phone Province 009833950154 Tehran Email Postal code 1145847311 [email protected] Phone +98 21 3395 0154 Sharing plan Email [email protected] Deidentified Individual Participant Data Set (IPD) Yes - There is a plan to make this available Person responsible for scientific Study Protocol Yes - There is a plan to make this available inquiries Statistical Analysis Plan Contact Yes - There is a plan to make this available Name of organization / entity Informed Consent Form Research Institute for Islamic and Complementary Yes - There is a plan to make this available Medicine Clinical Study Report Full name of responsible person Yes - There is a plan to make this available Fataneh Hashem-Dabaghian Analytic Code Position Not applicable Associate professor Data Dictionary Latest degree No - There is not a plan to make this available Specialist Title and more details about the data/document Other areas of specialty/work The data od the main outcome can be shared. Others When the data will become available and for how Street address long No: 9, Pirnia alley, Lalehzar-no St., Jomhuri Ave. starting 6 months after publication of article City To whom data/document is available Tehran The data will be available for researchers in Province complementary medicine. Tehran Under which criteria data/document could be used Postal code Requests will be reviewed. 1145847311 From where data/document is obtainable Phone please mail to: [email protected] +98 21 3395 0154 What processes are involved for a request to access Email data/document [email protected] After reviewing the request, the answer will be provided by email Person responsible for updating data Comments

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