Determining the effect of Auricular therapy on behavioral symptoms of ADHD in children aged 6-12 years.
Design
Random with parallel groups with control group, study population of 60 children aged 6-12 years with Attention Deficit Hyperactivity Disorder
Settings and conduct
The research is performed in the clinic of Kargarnejhad Psychiatric Hospital in Kashan. The sampling method is convenience and assigned to the two groups using block randomization.
Participants/Inclusion and exclusion criteria
The sample study is 60 children aged 6-12 years with ADHD. Inclusion criteria include diagnosis of Attention Deficit Hyperactivity Disorder by a Pediatric Psychiatry, age range of 6-12 years, having Iranian nationality, living in Kashan and speak in Persian. Exclusion criteria :Unwillingness of the child and parents , infection or wound in the ear, using of acupuncture or acupressure or complementary therapies In the last 3 months.
Intervention groups
Intervention group: Auriculotherapy in the intervention group by applying moderate and uniform pressure of the index finger and thumb of a trained person or parent on a plant septum attached to the points affecting ADHD according to the standard map of ear points (ISAP). It included: Shen Men - Master Cerebral point-Point zero- Nervous Subcortex - Master Oscillation Point is done. The intervention is performed twice a day and each time each point is pressed for 1 minute and continues for 4 weeks. Control group received massage in other points as a placebo.
Main outcome variables
Behavioral symptoms of ADHD
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130721014086N14
Registration date:2020-12-10, 1399/09/20
Registration timing:registered_while_recruiting
Last update:2020-12-10, 1399/09/20
Update count:0
Registration date
2020-12-10, 1399/09/20
Registrant information
Name
Mohammad Aghajani
Name of organization / entity
Kashan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 5554 2001
Email address
aghajani_m@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-11-25, 1399/09/05
Expected recruitment end date
2021-04-21, 1400/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Auriculotherapy on behavioral symptoms of Attention Deficit Hyperactivity Disorder in 6-12 years' children
Public title
Therapeutic effect of Acupressure in Hyperactive children
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of Attention Deficit / Hyperactivity Disorder based on the case and diagnosis of pediatric psychiatry
Willingness of the child and parents to participate in the study (expressing the working method in simple language and asking the child to participate)
ADHD children aged 6-12 years who are being treated by a child psychiatrist.
Having Iranian nationality, Persian language and living in Kashan
Exclusion criteria:
Existence of ulcer or infection in the ear
Do not use acupressure or acupuncture and complementary therapies in the last 3 months
Age
From 6 years old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization method was used to assign two groups. In this way, the samples were assigned to two intervention and control groups in the form of 7 blocks of 4 using Excel software.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kashan University of Medical Sciences
Street address
Ravandi ghotb st- Kashan
City
Kashan
Province
Isfehan
Postal code
88715973474
Approval date
2020-11-25, 1399/09/05
Ethics committee reference number
IR.KAUMS.NUHEPM.REC.1399.069
Health conditions studied
1
Description of health condition studied
Attention Deficit Hyperactivity Disorder
ICD-10 code
F90.0
ICD-10 code description
Other behavioral and emotional disorders with onset usually occurring in childhood and adolescence
Primary outcomes
1
Description
Severity of ADHD behavioral symptoms
Timepoint
Beginning of the study, weeks 4 and 8
Method of measurement
Aachenbach Child Behavior Inventory (CBCL)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Auriculotherapy in the intervention group by applying moderate and uniform pressure of the index finger and thumb of a trained person or parent on a plant septum attached to the points affecting ADHD according to the standard map of ear points (ISAP) including: Shen Men - Master Cerebral point-Point zero- Nervous Subcortex - Master Oscillation Point is done. The intervention is performed twice a day and each time each point is pressed for 1 minute and continues for 4 weeks.
Category
Treatment - Devices
2
Description
Control group: : receive massage in other places as a placebo
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Kargarnejad Psychiatric Hospital
Full name of responsible person
Fateme Mahdavi
Street address
University of Medical Sciences-Kashan
City
Kashan
Province
Isfehan
Postal code
8715973446
Phone
+98 31 5554 9113
Fax
+98 31 5554 0036
Email
fatememahdavi15165@email.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Dr. Hamidreza Banafsheh
Street address
Ghotbe Ravandi, Kashan
City
Kashan
Province
Isfehan
Postal code
8715988141
Phone
+98 31 5557 8011
Fax
Email
research@kaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Mohammad Aghajani
Position
lectuerer
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Km 3 Ghotbe Ravandi, Kashan
City
kashan
Province
Isfehan
Postal code
8715988141
Phone
+98 31 5554 3591
Email
aghajani1362@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Mohammad Aghajani
Position
lecturer
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Km 3 Ghotbe Ravandi, Kashan
City
Kashan
Province
Isfehan
Postal code
8715988141
Phone
+98 36115550021
Email
aghajani1362@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Mohammad Aghajani
Position
lecturer
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Km 3 Ghotbe Ravandi, Kashan
City
Kashan
Province
Isfehan
Postal code
8715988141
Phone
+98 36 1555 0021
Email
aghajani_m@kaums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available