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Protocol summary
The purpose of this study is the evaluation of efficacy of adding acupuncture to methylphenidate in treatment of attention deficit hyperactivity disorder in children and adolescents.This is a randomized-double blind trial that its inclusion criteria include:informed consent from participants and therir parents,10-18 years of age,ADHD diagnosis by 2 child psychitrists,not having comorbidities including mental retardation,epilepsy,pervasive developmental disorder,schizophrenia,manic episode,anxiety disorders,bipolar disorder,learning disorders of special skills and hyperactivity caused by organic disorders or drug reactions by clinical interview,being on treatment by methylphenidate(Ritalin) or Ritalin and clonidine and its exclusion criteria include: those who do not tolerate acupuncture,non-compliance and change in other treatments during study.The study sample size is 45 persons in each group and totally 90 persons.12 sessions of acupuncture is done for everyone in patient group (3 sessions weekly) and 12 sessions of sham acupuncture is done for everyone in control group.Before treatment and 3 weeks after acupuncture participants are tested with ADHD rating scale-IV and Continuous Performance Test by a blind evaluator and the results are compared with each other.
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The purpose of this study is the evaluation of efficacy of adding acupuncture to methylphenidate in treatment of attention deficit hyperactivity disorder in children and adolescents.This is a randomized-double blind trial that its inclusion criteria include:informed consent from participants and therir parents,10-18 years of age,ADHD diagnosis by 2 child psychitrists,not having comorbidities including mental retardation,epilepsy,pervasive developmental disorder,schizophrenia,manic episode,anxiety disorders,bipolar disorder,learning disorders of special skills and hyperactivity caused by organic disorders or drug reactions by clinical interview,being on treatment by methylphenidate(Ritalin) or Ritalin and clonidine and its exclusion criteria include: those who do not tolerate acupuncture,non-compliance and change in other treatments during study.The study sample size is 45 persons in each group and totally 90 persons.12 sessions of acupuncture is done for everyone in patient group (3 sessions weekly) and 12 sessions of sham acupuncture is done for everyone in control group.Before treatment and 3 weeks after acupuncture participants are tested with ADHD rating scale-IV and Continuous Performance Test by a blind evaluator and the results are compared with each other.
هدف این مطالعه بررسی اثر بخشی افزودن درمان طب سوزنی به درمان با متیل فنیدیت در اختلال کمبود توجه-بیش فعالی کودکان و نوجوانان می باشد.این یک مطالعه تصادفی-دوسویه کور است که معیارهای ورود آن شامل:رضایت آگاهانه ی شفاهی و کتبی از والدین و شرکت کنندگان،سن 10 تا 18 سال،تشخیص ADHD بر اساس کرایتریای DSM-V با تأیید توسط دو فوق تخصص روانپزشکی اطفال،عدم ابتلا به عقب ماندگی ذهنی،اپی لپسی،اختلالات نافذ رشد،اسکیزوفرنی،اپیزود مانیا،اختلالات اضطرابی،اختلالات دوقطبی،اختلالات یادگیری مهارت های خاص و علایم بیش فعالی ایجاد شده بوسیله ی اختلالات ارگانیک یا واکنش های دارویی بر اساس مصاحبه بالینی توسط روانپزشک و نهایتا درمان دارویی با متیل فنیدیت(ریتالین) یا ریتالین و کلونیدین بوده و معیار های خروج شامل عدم تحمل درمان طب سوزنی ،کمپلیانس پایین و تغییر در درمان های دیگر حین مطالعه می باشد.حجم نمونه 45 نفر در هر گروه و مجموعا 90 نفر می باشد.12 جلسه درمان طب سوزنی در گروه بیماران و 12 جلسه sham acupuncture در گروه کنترل (3 جلسه در هفته) برای هر فرد انجام خواهد شد.قبل از شروع مداخله و 3 هفته بعد از پایان جلسات طب سوزنی توسط یک ارزیاب blind افراد با استفاده از ADHD rating scale-IV و تست عملکرد عصبی- شناختی کامپیوتری (آزمون عملکرد پیوسته یا CPT)مورد بررسی قرار می گیرند و نتایج دو گروه با هم مقایسه خواهند شد.
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هدف این مطالعه بررسی اثر بخشی افزودن درمان طب سوزنی به درمان با متیل فنیدیت در اختلال کمبود توجه-بیش فعالی کودکان و نوجوانان می باشد.این یک مطالعه تصادفی-دوسویه کور است که معیارهای ورود آن شامل:رضایت آگاهانه ی شفاهی و کتبی از والدین و شرکت کنندگان،سن 10 تا 18 سال،تشخیص ADHD بر اساس کرایتریای DSM-V با تأیید توسط دو فوق تخصص روانپزشکی اطفال،عدم ابتلا به عقب ماندگی ذهنی،اپی لپسی،اختلالات نافذ رشد،اسکیزوفرنی،اپیزود مانیا،اختلالات اضطرابی،اختلالات دوقطبی،اختلالات یادگیری مهارت های خاص و علایم بیش فعالی ایجاد شده بوسیله ی اختلالات ارگانیک یا واکنش های دارویی بر اساس مصاحبه بالینی توسط روانپزشک و نهایتا درمان دارویی با متیل فنیدیت(ریتالین) یا ریتالین و کلونیدین بوده و معیار های خروج شامل عدم تحمل درمان طب سوزنی ،کمپلیانس پایین و تغییر در درمان های دیگر حین مطالعه می باشد.حجم نمونه 45 نفر در هر گروه و مجموعا 90 نفر می باشد.12 جلسه درمان طب سوزنی در گروه بیماران و 12 جلسه sham acupuncture در گروه کنترل (3 جلسه در هفته) برای هر فرد انجام خواهد شد.قبل از شروع مداخله و 3 هفته بعد از پایان جلسات طب سوزنی توسط یک ارزیاب blind افراد با استفاده از ADHD rating scale-IV و تست عملکرد عصبی- شناختی کامپیوتری (آزمون عملکرد پیوسته یا CPT)مورد بررسی قرار می گیرند و نتایج دو گروه با هم مقایسه خواهند شد.
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The evaluation of efficacy of adding acupuncture to Methylphenidate in treatment of attention deficit hyperactivity disorder in children and adolescents
The evaluation of efficacy of adding acupuncture to Methylphenidate in treatment of attention deficit hyperactivity disorder in children and adolescents
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بررسی اثر بخشی افزودن درمان طب سوزنی به درمان با متیل فنیدیت در اختلال کمبود توجه-بیش فعالی کودکان و نوجوانان
بررسی اثر بخشی افزودن درمان طب سوزنی به درمان با متیل فنیدیت در اختلال کمبود توجه-بیش فعالی کودکان و نوجوانان
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A randomized, double blinded, sham controlled clinical trial with a parallel group design of 90 patients
A randomized, double blinded, sham controlled clinical trial with a parallel group design of 90 patients
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کارآزمایی بالینی دو سویه کور، کنترل شده با sham، با گروه های موازی روی 90 بیمار
کارآزمایی بالینی دو سویه کور، کنترل شده با sham، با گروه های موازی روی 90 بیمار
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This study was conducted on patients with confirmed ADHD referred to Ibn-e-Sina Psychiatric Hospital, Mashhad, Iran between January 2017 and June 2017. Patients were randomly allocated into acupuncture (experimental group) or sham acupuncture (control group). All patients received a standard treatment of 0.3-1 mg/kg of Methylphenidate (Ritalin) in 2 or 3 divided doses. Before the intervention patients were evaluated using home version of ADHD-rating scale (RS) and Continuous Performance Test. Then within 4 weeks the intervention group received acupuncture treatment 3 times a week. Sham acupuncture was used for the control group within the same duration as acupuncture group. The treatment outcomes were measured using home version of ADHD-rating scale (RS) and Continuous Performance Test after 3 weeks. Patients, their parents, child and adolescent psychiatrist and the psychologist who performed before-after tests were not aware of grouping.
This study was conducted on patients with confirmed ADHD referred to Ibn-e-Sina Psychiatric Hospital, Mashhad, Iran between January 2017 and June 2017. Patients were randomly allocated into acupuncture (experimental group) or sham acupuncture (control group). All patients received a standard treatment of 0.3-1 mg/kg of Methylphenidate (Ritalin) in 2 or 3 divided doses. Before the intervention patients were evaluated using home version of ADHD-rating scale (RS) and Continuous Performance Test. Then within 4 weeks the intervention group received acupuncture treatment 3 times a week. Sham acupuncture was used for the control group within the same duration as acupuncture group. The treatment outcomes were measured using home version of ADHD-rating scale (RS) and Continuous Performance Test after 3 weeks. Patients, their parents, child and adolescent psychiatrist and the psychologist who performed before-after tests were not aware of grouping.
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این مطالعه بر روی بیماران با ADHD تایید شده مراجعه کننده به بیمارستان روانپزشکی ابن سینای مشهد بین دی ماه 1395 تا تیرماه 1396 انجام گرفت. بیماران به صورت تصادفی به دو گروه طب سوزنی(گروه آزمایش) و گروه طب سوزنی ساختگی(گروه کنترل) تقسیم شدند. تمام بیماران درمان دارویی استاندارد 0.3 تا 1 میلیگرم برای هر کیلوگرم متیل فنیدیت(ریتالین) در 2 یا 3 دوز منقسم دریافت میکردند. قبل از مداخله بیماران با استفاده از فرم منزل ADHD-rating scale و آزمون عملکرد پیوسته ارزیابی می شدند. سپس در مدت 4 هفته بر روی گروه مداخله 3 جلسه در هفته درمان طب سوزنی انجام می شد. برای گروه کنترل طب سوزنی ساختگی با طول مدت مشابه انجام می شد. پیامدهای درمان با استفاده از فرم منزل ADHD-rating scale و آزمون عملکرد پیوسته بعد از 3 هفته از پایان درمان اندازه گیری می شد.بیماران، والدین آن ها، روانپزشک کودک و نوجوان و روانشناسی که تست های قبل و بعد را انجام میداد از گروه ها اطلاعی نداشتند.
این مطالعه بر روی بیماران با ADHD تایید شده مراجعه کننده به بیمارستان روانپزشکی ابن سینای مشهد بین دی ماه 1395 تا تیرماه 1396 انجام گرفت. بیماران به صورت تصادفی به دو گروه طب سوزنی(گروه آزمایش) و گروه طب سوزنی ساختگی(گروه کنترل) تقسیم شدند. تمام بیماران درمان دارویی استاندارد 0.3 تا 1 میلیگرم برای هر کیلوگرم متیل فنیدیت(ریتالین) در 2 یا 3 دوز منقسم دریافت میکردند. قبل از مداخله بیماران با استفاده از فرم منزل ADHD-rating scale و آزمون عملکرد پیوسته ارزیابی می شدند. سپس در مدت 4 هفته بر روی گروه مداخله 3 جلسه در هفته درمان طب سوزنی انجام می شد. برای گروه کنترل طب سوزنی ساختگی با طول مدت مشابه انجام می شد. پیامدهای درمان با استفاده از فرم منزل ADHD-rating scale و آزمون عملکرد پیوسته بعد از 3 هفته از پایان درمان اندازه گیری می شد.بیماران، والدین آن ها، روانپزشک کودک و نوجوان و روانشناسی که تست های قبل و بعد را انجام میداد از گروه ها اطلاعی نداشتند.
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Inclusion criteria: 6 to 18 year old patients with the diagnosis of ADHD by DSM-5 criteria who are on the standard treatment with Methylphenidate or Methylphenidate and Clonidine without any dose change from 2 weeks before the study and during the study
Exclusion criteria: patients with mental retardation, epilepsy, pervasive developmental disorders, schizophrenia, manic episode, mood and anxiety disorders and drug or organic disorder induced hyperactivity
Inclusion criteria: 6 to 18 year old patients with the diagnosis of ADHD by DSM-5 criteria who are on the standard treatment with Methylphenidate or Methylphenidate and Clonidine without any dose change from 2 weeks before the study and during the study Exclusion criteria: patients with mental retardation, epilepsy, pervasive developmental disorders, schizophrenia, manic episode, mood and anxiety disorders and drug or organic disorder induced hyperactivity
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شرایط ورود: افراد 6 تا 18 ساله با تشخیص ADHD بر اساس کرایتریای DSM-5 که تحت درمان استاندارد با متیل فنیدیت یا متیل فنیدیت و کلونیدین هستند و دوز دارویشان از دو هفته قبل از مطالعه و حین آن تغییر نمیکند.
شرایط عدم ورود: ابتلا به عقب ماندگی ذهنی، اپی لپسی، اختلالات نافذ رشد، اسکیزوفرنی، اپیزود مانیا، اختلالات خلقی و اضطرابی و علایم بیش فعالی ایجاد شده بوسیله ی اختلالات ارگانیک یا داروها
شرایط ورود: افراد 6 تا 18 ساله با تشخیص ADHD بر اساس کرایتریای DSM-5 که تحت درمان استاندارد با متیل فنیدیت یا متیل فنیدیت و کلونیدین هستند و دوز دارویشان از دو هفته قبل از مطالعه و حین آن تغییر نمیکند. شرایط عدم ورود: ابتلا به عقب ماندگی ذهنی، اپی لپسی، اختلالات نافذ رشد، اسکیزوفرنی، اپیزود مانیا، اختلالات خلقی و اضطرابی و علایم بیش فعالی ایجاد شده بوسیله ی اختلالات ارگانیک یا داروها
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Acupuncture (experimental group) and sham acupuncture (control group)
Acupuncture (experimental group) and sham acupuncture (control group)
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گروه طب سوزنی(گروه آزمایش) و گروه طب سوزنی ساختگی(گروه کنترل)
گروه طب سوزنی(گروه آزمایش) و گروه طب سوزنی ساختگی(گروه کنترل)
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Score of ADHD-rating scale; score of CPT
Score of ADHD-rating scale; score of CPT
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نمره ADHD-rating scale; نمره CPT
نمره ADHD-rating scale; نمره CPT
General information
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6
106
1
1
1
1
1
1
1
1
1
1
Not used
Used
nusedused
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90
90
2015-09-23, 1394/07/01
2016-08-22, 1395/06/01
20152016-0908-2322 00:00:00
2016-09-22, 1395/07/01
2017-03-20, 1395/12/30
20162017-0903-2220 00:00:00
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2016-12-21, 1395/10/01
2016-12-21 00:00:00
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2017-06-20, 1396/03/30
2017-06-20 00:00:00
acupuncture in treatment of attention deficit hyperactivity disorder in children and adolescents
Acupuncture in treatment of attention deficit hyperactivity disorder in children and adolescents
acupunctureAcupuncture in treatment of attention deficit hyperactivity disorder in children and adolescents
A Study of effect of adding acupuncture to methylphenidate in treatment of attention deficit hyperactivity disorder(ADHD) in children and adolescents
A Study of effect of adding acupuncture to Methylphenidate in treatment of attention deficit hyperactivity disorder(ADHD) in children and adolescents
A Study of effect of adding acupuncture to methylphenidateMethylphenidate in treatment of attention deficit hyperactivity disorder(ADHD) in children and adolescents
Written and oral informed consent by parents of participants
Age between 6 to 18 years
The diagnosis of ADHD according to DSM-5 criteria by a child and adolescent psychiatrist
Being on the standard treatment with Methylphenidate or Methylphenidate and Clonidine without any dose changes from 2 weeks before and during the study period
Written and oral informed consent by parents of participants Age between 6 to 18 years The diagnosis of ADHD according to DSM-5 criteria by a child and adolescent psychiatrist Being on the standard treatment with Methylphenidate or Methylphenidate and Clonidine without any dose changes from 2 weeks before and during the study period
رضایت آگاهانه کتبی و شفاهی والدین شرکت کنندگان
سن بین 6 تا 18 سال
تشخیص ADHD بر اساس کرایتریای DSM-5 با تأیید فوق تخصص روانپزشکی اطفال
قرار داشتن تحت درمان استاندارد با متیل فنیدیت یا متیل فنیدیت و کلونیدین بدون هیچ گونه تغییر دوز از دو هفته قبل و حین مطالعه
رضایت آگاهانه کتبی و شفاهی والدین شرکت کنندگان سن بین 6 تا 18 سال تشخیص ADHD بر اساس کرایتریای DSM-5 با تأیید فوق تخصص روانپزشکی اطفال قرار داشتن تحت درمان استاندارد با متیل فنیدیت یا متیل فنیدیت و کلونیدین بدون هیچ گونه تغییر دوز از دو هفته قبل و حین مطالعه
Patients with mental retardation, epilepsy, pervasive developmental disorders, schizophrenia, manic episode, mood and anxiety disorders and drug or organic disorder induced hyperactivity
Any dose change in the standard drug therapy during the study period
Patients with mental retardation, epilepsy, pervasive developmental disorders, schizophrenia, manic episode, mood and anxiety disorders and drug or organic disorder induced hyperactivity Any dose change in the standard drug therapy during the study period
بیماران با عقب ماندگی ذهنی، اپی لپسی، اختلالات نافذ رشد، اسکیزوفرنی، اپیزود مانیا ،اختلالات خلقی و اضطرابی و علایم بیش فعالی ایجاد شده بوسیله ی اختلالات ارگانیک یا داروها
هر گونه تغییر دوز در دارودرمانی استاندارد حین مطالعه
بیماران با عقب ماندگی ذهنی، اپی لپسی، اختلالات نافذ رشد، اسکیزوفرنی، اپیزود مانیا ،اختلالات خلقی و اضطرابی و علایم بیش فعالی ایجاد شده بوسیله ی اختلالات ارگانیک یا داروها هر گونه تغییر دوز در دارودرمانی استاندارد حین مطالعه
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Simple randomization by using a random number table
Simple randomization by using a random number table
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تصادفی سازی ساده با استفاده از یک جدول اعداد تصادفی
تصادفی سازی ساده با استفاده از یک جدول اعداد تصادفی
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Randomization was done by a researcher who was not aware of the study protocol and outcomes. Patients and their parents, as well as child and adolescent psychiatrist were not aware of grouping, Moreover, the psychologist, who was the researcher-in-charge of before-after tests, was not aware of interventions. Also, the outcomes of the study were recorded by the psychiatrist who made no other contribution to the study.
Randomization was done by a researcher who was not aware of the study protocol and outcomes. Patients and their parents, as well as child and adolescent psychiatrist were not aware of grouping, Moreover, the psychologist, who was the researcher-in-charge of before-after tests, was not aware of interventions. Also, the outcomes of the study were recorded by the psychiatrist who made no other contribution to the study.
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تصادفی سازی توسط محققی انجام میشد که از پروتکل مطالعه و پیامدها اطلاعی نداشت. بیماران و والدینشان و نیز روانپزشک کودک و نوجوان از گروه ها اطلاعی نداشتن، علاوه بر این روانشناسی که مسئوال انجام تست های قبل و بعد بود از مداخلات اطلاعی نداشت. همچنین پیامدهای مطالعه توسط روانپزشکی که همکاری دیگری در مطالعه نداشت انجام میشد.
تصادفی سازی توسط محققی انجام میشد که از پروتکل مطالعه و پیامدها اطلاعی نداشت. بیماران و والدینشان و نیز روانپزشک کودک و نوجوان از گروه ها اطلاعی نداشتن، علاوه بر این روانشناسی که مسئوال انجام تست های قبل و بعد بود از مداخلات اطلاعی نداشت. همچنین پیامدهای مطالعه توسط روانپزشکی که همکاری دیگری در مطالعه نداشت انجام میشد.
Primary outcomes
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before the intervention and 3 weeks after the intervention
Before the intervention and 3 weeks after the intervention
beforeBefore the intervention and 3 weeks after the intervention
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before the intervention and 3 weeks after the intervention
Before the intervention and 3 weeks after the intervention
beforeBefore the intervention and 3 weeks after the intervention
Recruitment centers
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Name of recruitment center - English: Ebne Sina Hospital Outpatient Clinics
Name of recruitment center - Persian: کلینیک های سرپایی بیمارستان روانپزشکی ابن سینا مشهد
Full name of responsible person - English: Mahsa Nahidi
Full name of responsible person - Persian: مهسا ناهیدی
Street address - English:
Street address - Persian:
City - English: Mashhad
City - Persian: مشهد
Province:
Country: Iran (Islamic Republic of)
Postal code:
Phone:
Fax:
Email:
Web page address:
Name of recruitment center - English: Ebne Sina Hospital Outpatient Clinics
Name of recruitment center - Persian: کلینیک های سرپایی بیمارستان روانپزشکی ابن سینا مشهد
Full name of responsible person - English: Mahsa Nahidi
Full name of responsible person - Persian: مهسا ناهیدی
Street address - English: Hor-e-Ameli Blvd
Street address - Persian: بلوار حر عاملی
City - English: Mashhad
City - Persian: مشهد
Province: Razavi Khorasan
Country: Iran (Islamic Republic of)
Postal code: 9197987532
Phone: +98 51 3711 2723
Fax:
Email: nahidimh@mums.ac.ir
Web page address:
Name of recruitment center - English: Ebne Sina Hospital Outpatient Clinics Name of recruitment center - Persian: کلینیک های سرپایی بیمارستان روانپزشکی ابن سینا مشهد Full name of responsible person - English: Mahsa Nahidi Full name of responsible person - Persian: مهسا ناهیدی Street address - English: Hor-e-Ameli Blvd Street address - Persian: بلوار حر عاملی City - English: Mashhad City - Persian: مشهد Province: Razavi Khorasan Country: Iran (Islamic Republic of) Postal code: 9197987532 Phone: +98 51 3711 2723 Fax: Email: nahidimh@mums.ac.ir Web page address:
Sponsors / Funding sources
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contact.organization_id:
Name of organization / entity - English: Research Affairs of Mashhad University of Medical Sciences
Name of organization / entity - Persian: معاونت پژوهشی دانشگاه علوم پزشکی مشهد
Full name of responsible person - English: Dr. Mohammad Reza Fayyazi Bordbar
Full name of responsible person - Persian: دکتر محمدرضا فیاضی بردبار
Street address - English: Ghoreishi building, ,Daneshgah St., Mashhad, Khorasan Razavi
Street address - Persian: خراسان رضوی، مشهد، خیابان دانشگاه، ساختمان قریشی
City - English: Mashhad
City - Persian: مشهد
Province:
Country: Iran (Islamic Republic of)
Postal code:
Phone:
Fax:
Email:
Web page address:
contact.organization_id:
Name of organization / entity - English: Research Affairs of Mashhad University of Medical Sciences
Name of organization / entity - Persian: معاونت پژوهشی دانشگاه علوم پزشکی مشهد
Full name of responsible person - English: Dr. Mohammad Reza Fayyazi Bordbar
Full name of responsible person - Persian: دکتر محمدرضا فیاضی بردبار
Street address - English: Ghoreishi building, ,Daneshgah St., Mashhad, Khorasan Razavi
Street address - Persian: خراسان رضوی، مشهد، خیابان دانشگاه، ساختمان قریشی
City - English: Mashhad
City - Persian: مشهد
Province: Razavi Khorasan
Country: Iran (Islamic Republic of)
Postal code: 1394491388
Phone: +98 51 3841 2081
Fax:
Email: fayyazimr@mums.ac.ir
Web page address:
contact.organization_id: Name of organization / entity - English: Research Affairs of Mashhad University of Medical Sciences Name of organization / entity - Persian: معاونت پژوهشی دانشگاه علوم پزشکی مشهد Full name of responsible person - English: Dr. Mohammad Reza Fayyazi Bordbar Full name of responsible person - Persian: دکتر محمدرضا فیاضی بردبار Street address - English: Ghoreishi building, ,Daneshgah St., Mashhad, Khorasan Razavi Street address - Persian: خراسان رضوی، مشهد، خیابان دانشگاه، ساختمان قریشی City - English: Mashhad City - Persian: مشهد Province: Razavi Khorasan Country: Iran (Islamic Republic of) Postal code: 1394491388 Phone: +98 51 3841 2081 Fax: Email: fayyazimr@mums.ac.ir Web page address:
empty
Public
public
empty
Domestic
domestic
empty
Academic
academic
Person responsible for general inquiries
contact.organization_id:
Name of organization / entity - English: Mashhad University of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشکی مشهد
Full name of responsible person - English: Mahsa Nahidi
Full name of responsible person - Persian: مهسا ناهیدی
Position - English: psychiatry resident
Position - Persian: دستیار تخصصی روانپزشکی
Latest degree:
Area of specialty/work: 0
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Ebne Sina Hospital, Mashhad, Khorasan Razavi
Street address - Persian: خراسان رضوی، مشهد، بیمارستان ابن سینا
City - English: Mashhad
City - Persian: مشهد
Province:
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code:
Phone: +98 51 3711 2701
Mobile: +98 915 512 5772
Fax:
Email: nahidim921@mums.ac.ir
Web page address:
contact.organization_id:
Name of organization / entity - English: Mashhad University of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشکی مشهد
Full name of responsible person - English: Mahsa Nahidi
Full name of responsible person - Persian: مهسا ناهیدی
Position - English: Assistant Professor
Position - Persian: استادیار
Latest degree: specialist
Area of specialty/work: 47
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Ebne Sina Hospital, Mashhad, Khorasan Razavi
Street address - Persian: خراسان رضوی، مشهد، بیمارستان ابن سینا
City - English: Mashhad
City - Persian: مشهد
Province: Razavi Khorasan
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 9197987532
Phone: +98 51 3711 2701
Mobile: +98 915 512 5772
Fax:
Email: nahidimh@mums.ac.ir
Web page address:
contact.organization_id: Name of organization / entity - English: Mashhad University of Medical Sciences Name of organization / entity - Persian: دانشگاه علوم پزشکی مشهد Full name of responsible person - English: Mahsa Nahidi Full name of responsible person - Persian: مهسا ناهیدی Position - English: psychiatry residentAssistant Professor Position - Persian: دستیار تخصصی روانپزشکیاستادیار Latest degree: specialist Area of specialty/work: 047 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Ebne Sina Hospital, Mashhad, Khorasan Razavi Street address - Persian: خراسان رضوی، مشهد، بیمارستان ابن سینا City - English: Mashhad City - Persian: مشهد Province: Razavi Khorasan Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 9197987532 Phone: +98 51 3711 2701 Mobile: +98 915 512 5772 Fax: Email: nahidim921nahidimh@mums.ac.ir Web page address:
Person responsible for scientific inquiries
contact.organization_id:
Name of organization / entity - English: Mashhad University of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشکی مشهد
Full name of responsible person - English: Fateme Moharari
Full name of responsible person - Persian: فاطمه محرری
Position - English: associate professor
Position - Persian: دانشیاری
Latest degree:
Area of specialty/work: 0
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Ebne Sina Hospital, Mashhad, Khorasan Razavi
Street address - Persian: خراسان رضوی، مشهد، بیمارستان ابن سینا
City - English: Mashhad
City - Persian: مشهد
Province:
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code:
Phone: +98 51 3711 2701
Mobile: +98 915 508 9682
Fax:
Email: mohararif1@mums.ac.ir
Web page address:
contact.organization_id:
Name of organization / entity - English: Mashhad University of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشکی مشهد
Full name of responsible person - English: Fateme Moharari
Full name of responsible person - Persian: فاطمه محرری
Position - English: associate professor
Position - Persian: دانشیاری
Latest degree: sub_specialist
Area of specialty/work: 47
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Ebne Sina Hospital, Mashhad, Khorasan Razavi
Street address - Persian: خراسان رضوی، مشهد، بیمارستان ابن سینا
City - English: Mashhad
City - Persian: مشهد
Province: Razavi Khorasan
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 9197987532
Phone: +98 51 3711 2701
Mobile: +98 915 508 9682
Fax:
Email: mohararif1@mums.ac.ir
Web page address:
contact.organization_id: Name of organization / entity - English: Mashhad University of Medical Sciences Name of organization / entity - Persian: دانشگاه علوم پزشکی مشهد Full name of responsible person - English: Fateme Moharari Full name of responsible person - Persian: فاطمه محرری Position - English: associate professor Position - Persian: دانشیاری Latest degree: sub_specialist Area of specialty/work: 047 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Ebne Sina Hospital, Mashhad, Khorasan Razavi Street address - Persian: خراسان رضوی، مشهد، بیمارستان ابن سینا City - English: Mashhad City - Persian: مشهد Province: Razavi Khorasan Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 9197987532 Phone: +98 51 3711 2701 Mobile: +98 915 508 9682 Fax: Email: mohararif1@mums.ac.ir Web page address:
Person responsible for updating data
contact.organization_id:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Mahsa Nahidi
Full name of responsible person - Persian: مهسا ناهیدی
Position - English:
Position - Persian:
Latest degree:
Area of specialty/work: 0
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English:
Street address - Persian:
City - English:
City - Persian:
Province:
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code:
Phone: 00
Mobile: 00
Fax:
Email:
Web page address:
contact.organization_id:
Name of organization / entity - English: Mashhad University of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشکی مشهد
Full name of responsible person - English: Mahsa Nahidi
Full name of responsible person - Persian: مهسا ناهیدی
Position - English: Assistant professor
Position - Persian: استادیار
Latest degree: specialist
Area of specialty/work: 47
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Ebne Sina Hospital, Hor-e-Ameli Blvd
Street address - Persian: بيمارستان ابن سينا، بلوار حر عاملی
City - English: Mashhad
City - Persian: مشهد
Province: Razavi Khorasan
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 9197987532
Phone: +98 51 3764 9383
Mobile: +98 915 512 5772
Fax: +98 51 3711 2723
Email: nahidimh@mums.ac.ir
Web page address:
contact.organization_id: Name of organization / entity - English: Mashhad University of Medical Sciences Name of organization / entity - Persian: دانشگاه علوم پزشکی مشهد Full name of responsible person - English: Mahsa Nahidi Full name of responsible person - Persian: مهسا ناهیدی Position - English: Assistant professor Position - Persian: استادیار Latest degree: specialist Area of specialty/work: 047 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Ebne Sina Hospital, Hor-e-Ameli Blvd Street address - Persian: بيمارستان ابن سينا، بلوار حر عاملی City - English: Mashhad City - Persian: مشهد Province: Razavi Khorasan Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 9197987532 Phone: 00+98 51 3764 9383 Mobile: 00+98 915 512 5772 Fax: +98 51 3711 2723 Email: nahidimh@mums.ac.ir Web page address:
Sharing plan
undecided
undecided
undecided
undecided
undecided
undecided
undecided
undecided
undecided
undecided
undecided
undecided
undecided
undecided
empty
This decision will be made and declared after consultation with supervisors.
This decision will be made and declared after consultation with supervisors.
empty
این تصمیم بعد از مشورت با اساتید راهنما گرفته و اعلام خواهد شد.
این تصمیم بعد از مشورت با اساتید راهنما گرفته و اعلام خواهد شد.
Protocol summary
Study aim
The evaluation of efficacy of adding acupuncture to Methylphenidate in treatment of attention deficit hyperactivity disorder in children and adolescents
Design
A randomized, double blinded, sham controlled clinical trial with a parallel group design of 90 patients
Settings and conduct
This study was conducted on patients with confirmed ADHD referred to Ibn-e-Sina Psychiatric Hospital, Mashhad, Iran between January 2017 and June 2017. Patients were randomly allocated into acupuncture (experimental group) or sham acupuncture (control group). All patients received a standard treatment of 0.3-1 mg/kg of Methylphenidate (Ritalin) in 2 or 3 divided doses. Before the intervention patients were evaluated using home version of ADHD-rating scale (RS) and Continuous Performance Test. Then within 4 weeks the intervention group received acupuncture treatment 3 times a week. Sham acupuncture was used for the control group within the same duration as acupuncture group. The treatment outcomes were measured using home version of ADHD-rating scale (RS) and Continuous Performance Test after 3 weeks. Patients, their parents, child and adolescent psychiatrist and the psychologist who performed before-after tests were not aware of grouping.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 6 to 18 year old patients with the diagnosis of ADHD by DSM-5 criteria who are on the standard treatment with Methylphenidate or Methylphenidate and Clonidine without any dose change from 2 weeks before the study and during the study
Exclusion criteria: patients with mental retardation, epilepsy, pervasive developmental disorders, schizophrenia, manic episode, mood and anxiety disorders and drug or organic disorder induced hyperactivity
Intervention groups
Acupuncture (experimental group) and sham acupuncture (control group)
Main outcome variables
Score of ADHD-rating scale; score of CPT
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT2015091121852N1
Registration date:2016-11-27, 1395/09/07
Registration timing:prospective
Last update:2018-03-11, 1396/12/20
Update count:1
Registration date
2016-11-27, 1395/09/07
Registrant information
Name
Mahsa Nahidi
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 3764 9383
Email address
nahidimh@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad University of Medical Sciences
Expected recruitment start date
2016-08-22, 1395/06/01
Expected recruitment end date
2017-03-20, 1395/12/30
Actual recruitment start date
2016-12-21, 1395/10/01
Actual recruitment end date
2017-06-20, 1396/03/30
Trial completion date
empty
Scientific title
A Study of effect of adding acupuncture to Methylphenidate in treatment of attention deficit hyperactivity disorder(ADHD) in children and adolescents
Public title
Acupuncture in treatment of attention deficit hyperactivity disorder in children and adolescents
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Written and oral informed consent by parents of participants
Age between 6 to 18 years
The diagnosis of ADHD according to DSM-5 criteria by a child and adolescent psychiatrist
Being on the standard treatment with Methylphenidate or Methylphenidate and Clonidine without any dose changes from 2 weeks before and during the study period
Exclusion criteria:
Patients with mental retardation, epilepsy, pervasive developmental disorders, schizophrenia, manic episode, mood and anxiety disorders and drug or organic disorder induced hyperactivity
Any dose change in the standard drug therapy during the study period
Age
From 6 years old to 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
90
Actual sample size reached:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization by using a random number table
Blinding (investigator's opinion)
Double blinded
Blinding description
Randomization was done by a researcher who was not aware of the study protocol and outcomes. Patients and their parents, as well as child and adolescent psychiatrist were not aware of grouping, Moreover, the psychologist, who was the researcher-in-charge of before-after tests, was not aware of interventions. Also, the outcomes of the study were recorded by the psychiatrist who made no other contribution to the study.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Mashhad University of Medical Sciences
Before the intervention and 3 weeks after the intervention
Method of measurement
ADHD Rating Scale-IV questionnaire
2
Description
Continuous Performance Test score
Timepoint
Before the intervention and 3 weeks after the intervention
Method of measurement
Continuous Performance Test
Secondary outcomes
empty
Intervention groups
1
Description
Patient group will receive acupuncture for 12 sessions(three 40 minute sessions weekly).
Category
Treatment - Other
2
Description
Control group will receive sham acupuncture for12 sessions(three 40 minute sessions weekly).In this group special needles are used that do not enter the skin and acupoints are different from the patinent group.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Ebne Sina Hospital Outpatient Clinics
Full name of responsible person
Mahsa Nahidi
Street address
Hor-e-Ameli Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9197987532
Phone
+98 51 3711 2723
Email
nahidimh@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research Affairs of Mashhad University of Medical Sciences