Comparison of the effect of auricular acupuncture with the control group in children with ADHD
Design
In this phase 1-2 single blinde randomized clinical trial, 30 children are randomly assigned to intervention and control groups.
Intervention is performed 4 times with an interval of 1 week.
Settings and conduct
The study setting is the childcare centers is affiliated with the Tehran Welfare Organization. Blindness is only done for patients.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 6-14-year-old children with ADHD
Non-inclusion criteria: the history of epilepsy; schizophrenia; mental retardation (IQ less than 70); active depression; autism.
Intervention groups
Intervention group1: ٍAuricular acupuncture with electrical stimulation.
Intervention group 2: The seeds are placed on the ear on non-acupuncture points and are not stimulated.
Main outcome variables
Symptoms severity was assessed using the Conners and CSI questionnaire;
Changes in the symptoms of illness from the point of view of teachers.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20090527001957N9
Registration date:2019-09-30, 1398/07/08
Registration timing:registered_while_recruiting
Last update:2019-09-30, 1398/07/08
Update count:0
Registration date
2019-09-30, 1398/07/08
Registrant information
Name
Fataneh Hashem Dabaghian
Name of organization / entity
Research Institute for Islamic and Complementary Medicine
Country
Iran (Islamic Republic of)
Phone
+98 21 3395 0152
Email address
fatanehdabaghian@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-07-23, 1398/05/01
Expected recruitment end date
2020-02-20, 1398/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of efficacy of auricular acupuncture with a control group in childhood with Attention-deficit/hyperactivity disorder
Public title
auriculotherapy and ADHD
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
age 6-14 years
diagnosis of ADHD based on DSM- V criteria
informed consent of patients or their parents
If medication, education, occupational and psychological therapy are used, there has been no change in drug dosage or treatment or symptoms of ADHD for at least the past 2 weeks.
Exclusion criteria:
History of epilepsy
schizophrenia
neurological disorders
any psychological disorder requires medication
hyperthyroidism
Age
From 6 years old to 14 years old
Gender
Both
Phase
1-2
Groups that have been masked
Participant
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
A list is generated using a random number table and intervention A and B are assigned one by one. Sealed envelopes are used for allocation concealment, with the patient number on the envelope and the name of the intervention group inside the envelope.
Blinding (investigator's opinion)
Single blinded
Blinding description
In the intervention group, acupuncture seeds are placed at the acupuncture point of the ear and electrical stimulation is performed. In the control group, the seeds are placed on the non-acupuncture point on ear and no stimulation is performed. Patients are unaware of the type of interventions.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Iran University of Medical Sciences
Street address
Iran University of Medical Sciences, next to Milad tower, Himmat highway
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2018-10-28, 1397/08/06
Ethics committee reference number
IR.IUMS.REC.1397.579
Health conditions studied
1
Description of health condition studied
attention deficit hyperactivity disorder
ICD-10 code
F90
ICD-10 code description
Attention-deficit hyperactivity disorders
Primary outcomes
1
Description
severity of ADHD disorder
Timepoint
1 and 3 weeks after intervention
Method of measurement
Caner's and CSI questionnaire
Secondary outcomes
1
Description
changes of the disease severity from the viewpoint of teachers
Timepoint
3 weeks after intervention
Method of measurement
symptom severity checklist
Intervention groups
1
Description
Intervention group: Acupuncture seeds are placed at the specific site of the disease and electrical stimulation is performed once a week for 4 weeks. In case of falling seed, stimulation is done twice a week.
Category
Treatment - Other
2
Description
Control group: Acupuncture seeds are attached to non-acupuncture points on the ear and no electrical stimulation is performed.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Balandegan Adham center
Full name of responsible person
Tayebeh Aghahoseini
Street address
NO: 11, Agahi St., Dabestan Ave.,
City
Tehran
Province
Tehran
Postal code
1631766411
Phone
+98 21 8846 9624
Email
balandegan@yahoo.com
2
Recruitment center
Name of recruitment center
Shahid Ghodoosi center
Full name of responsible person
Jamileh Soofi
Street address
No: 14, Baradaran Tabrizi St., Yaser crossroad, Niavaran St.