Investigating the effectiveness of adding acupressure and ear acupuncture treatment to stimulant drugs in children and adolescents with attention deficit hyperactivity disorder
Investigating the effectiveness of adding acupressure and ear acupuncture treatment to stimulant drugs in children and adolescents with attention deficit hyperactivity disorder
Design
Clinical trial with control group, with parallel groups, randomized, on 102 patients. The rand function of Excel software was used for randomization.
Settings and conduct
In this study, children and adolescents referring to the outpatient clinics of Ibn Sina Psychiatric Hospital who meet the inclusion criteria are included in the plan. 102 people are randomly divided into two groups. Based on the standard treatment, clients are placed on the desired drug from the beginning (Ritalin with a maximum dose of 1 mg/kg in divided doses and Etomoxetine 1 mg/kg per day in divided doses) and it continues during their drug treatment.
Participants/Inclusion and exclusion criteria
Age 6 to 18 years,
ADHD diagnosis
Not suffering from mental retardation
Under medical treatment with stimulant drugs
Written and verbal informed consent from parents
Exclusion criteria:
Intolerance of acupressure or ear acupuncture treatment
Low compliance
Changes in drug therapy during the study
Intervention groups
In the intervention groups, in addition to the use of CNS stimulating drugs, acupressure and ear acupuncture treatments are also used.
In the control group, only CNS stimulating drugs are used.
Main outcome variables
Symptoms of hyperactivity in children and adolescents
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20101130005280N57
Registration date:2022-09-05, 1401/06/14
Registration timing:registered_while_recruiting
Last update:2022-09-05, 1401/06/14
Update count:0
Registration date
2022-09-05, 1401/06/14
Registrant information
Name
Raheleh Nejati
Name of organization / entity
Mashhad University of Medical Scinces, Ibn-e- Sina Psychiatric Hospital
Country
Iran (Islamic Republic of)
Phone
+98 51 3711 2540
Email address
nejatir2@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-08-23, 1401/06/01
Expected recruitment end date
2022-11-22, 1401/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effectiveness of adding acupressure and ear acupuncture treatment to stimulant drugs in children and adolescents with attention deficit hyperactivity disorder
Public title
Checking the effectiveness of adding acupressure and ear acupuncture treatment
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 6 to 18 years
ADHD diagnosis according to DSM-V with confirmation of a pediatric psychiatry subspecialist
Not suffering from mental retardation, epilepsy, pervasive developmental disorders, schizophrenia, manic episodes, anxiety disorders, bipolar disorders, learning disorders of specific skills and hyperactivity symptoms caused by organic disorders or drug reactions based on clinical interview. by a psychiatrist
Under medical treatment with stimulant drugs such as methylphenidate or atomoxetine
Written and verbal informed consent from parents
Exclusion criteria:
Intolerance of acupressure or ear acupuncture treatment
Low compliance
Changes in drug therapy during the study
Age
From 6 years old to 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
102
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization with table of random numbers available at ''www.randomization.com'' website will be used. Numbers will be placed in sealed envelopes and each envelope is assigned to one participant placing them in one of the two intervention groups.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not 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
Street address
Central Building of Mashhad University of Medical Sciences (Ghorshi), Daneshgah 16, Daneshgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
123456
Approval date
2022-03-16, 1400/12/25
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1400.840
Health conditions studied
1
Description of health condition studied
ADHD
ICD-10 code
F90.0
ICD-10 code description
Attention-deficit hyperactivity disorder, predominantly inattentive type
Primary outcomes
1
Description
ADHD Rating Scale
Timepoint
Before the intervention and the end of the first, second, third months
Method of measurement
Examination of the patient's symptoms by the doctor
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In the intervention groups, in addition to using CNS stimulating drugs, acupressure and ear acupuncture treatments are also used. The number of treatment sessions for acupressure is 12 sessions per month. At first, the first three sessions will be given the necessary training to the parents by the traditional medicine specialist and acupressure will be done in the presence of the parents, and then the parents will do it on their child at their own home and will be followed up by the psychiatric assistant who will implement the daily plan over the phone. Pressure has been applied. This process does not take more than a few minutes a day. Parents can be asked to do this on a daily basis as well. The number of ear acupuncture sessions is 12. The patient goes to the traditional medicine clinic of Imam Reza Hospital every day, and is given ear acupuncture sticks in the points by a traditional medicine specialist. It is clearly attached and it is explained to the parents on which sticks to press for how long each day. And in the middle of the day, the location of the sticks is moved by a traditional medicine expert. Before starting the acupressure and ear acupuncture treatment, the ADHD Rating Scale (1) is checked for all groups.
Category
Treatment - Other
2
Description
Control group: In the control group, only CNS stimulating drugs are used.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Ibn-e-Sina psychiatric Hospital
Full name of responsible person
Fatemeh Moharrari
Street address
Ibn-e-Sina psychiatric Hospital, Horre ameli avenue,boo Ali square
City
Mashhad
Province
Razavi Khorasan
Postal code
12345
Phone
+98 51 3711 2540
Email
faridhoseinif@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Majid Ghayour
Street address
Central Building of Mashhad University of Medical Sciences (Ghorshi), Daneshgah 16, Daneshgah street
City
Mashhad
Province
Razavi Khorasan
Postal code
9177899191
Phone
+98 51 3841 2081
Email
ramresearch@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Zohreh Mahdianpoor
Position
Specialist assistant
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Ibn-e-Sina psychiatric Hospital, Horre ameli avenue,boo Ali square
City
Mashhad
Province
Razavi Khorasan
Postal code
8313491959
Phone
+98 51 3711 2540
Email
faridhoseinif@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Fatemeh Moharrari
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Ibn-e-Sina psychiatric Hospital, Horre ameli avenue, Boo Ali square
City
Mashhad
Province
Razavi Khorasan
Postal code
9195983134
Phone
+98 51 3711 2721
Email
raikaravan@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Fatemeh Moharrari
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Ibn-e-Sina psychiatric Hospital, Horre ameli avenue, Boo Ali square
City
Mashhad
Province
Razavi Khorasan
Postal code
9195983134
Phone
+98 51 3711 2721
Email
raikaravan@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available