Comparison of the Effectiveness of methylphenidate with and without massage therapy on Attention Deficit-Hyperactivity Disorder among the Students of Primary Schools of Qom
The purpose of present study is to determine the effect of massage thrapy on ADHD students( attention deficit and hyperactivity disorder) . 30 students with pure ADHD diagnosed by a children psychiatrics that have taken methylphenidate more than 2 months include the study and researcher allocates them to control and intervention groups randomly. Control group take only methylphenidate and intervention group take methylphenidate and 10 minutes massage at bed time by mother for 30 days. Teachers complete the teacher conners questionnaire and mothers complete the parent conners questionnaire as well as mother-child relationship inventory and questionnaire of sleep pattern before and after intervention.Then the results are compared.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201305142531N2
Registration date:2013-11-11, 1392/08/20
Registration timing:prospective
Last update:
Update count:0
Registration date
2013-11-11, 1392/08/20
Registrant information
Name
Tahmineh Dadkhahtehrani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 7596
Email address
dadkhah-tehrani@muq.ac.ir
Recruitment status
Recruitment complete
Funding source
Qom University of Medical Sciences
Expected recruitment start date
2013-11-22, 1392/09/01
Expected recruitment end date
2014-02-19, 1392/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Effectiveness of methylphenidate with and without massage therapy on Attention Deficit-Hyperactivity Disorder among the Students of Primary Schools of Qom
Public title
Effects of massage on students with ADHD
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:obtaining score 20 or more in teacher conners questionnaire; more than two months after beginning methylphenidit with a stable situation; having age 7-12 years old; having no other psychological disorders; absence of mental retardation; having no history of convulsion; having no contraindication for massage
Exclusion criteria: irregular performing of massage program due to any causes; stopping the massage or methylphenidit; applying any other interventions to treat ADHD during study.
Age
From 7 years old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Local Ethics Committee of Qom University of Medical Sciences
Street address
Qom University of Medical Sciences, Shahid Lavsasani street, Qom, iran
City
Qom
Postal code
371364967
Approval date
2013-04-24, 1392/02/04
Ethics committee reference number
muq.rec.1392.7
Health conditions studied
1
Description of health condition studied
Attention Deficit/ Hyperactivity Disorders
ICD-10 code
F90.0
ICD-10 code description
Disturbance of activity and attention
Primary outcomes
1
Description
Symptoms of ADHD
Timepoint
Before intervention and just after 30 nights intervention
Method of measurement
Conners questionnaire of teacher and parents
Secondary outcomes
1
Description
Changes in pattern of sleep
Timepoint
2 times:1-just before intervention 2- just after 30 nights intervention
Method of measurement
with a valid and reliable questionnaire called BEARS
2
Description
weight changes
Timepoint
two times 1- before intervention 2- just after 30 nights intervention
Method of measurement
by a standard scale
3
Description
mother-child relationship
Timepoint
two times :1- befor intervention 2- just after 30 nights intervention
Method of measurement
ROBERT M Ross scale
Intervention groups
1
Description
in intervention group, in addition to taking methylphenidate tablets as before, subjects will be massaged by parent 10 minutes at bed time for 30 nights
Category
Other
2
Description
in control group ,subjects only take methylphenidate tablets as before
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Pediatric psychiatric office
Full name of responsible person
Dr. Shirin Moallemi
Street address
Amin building - alley 5- Amin boulvard-Qom- Iran
City
Qom
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Qom University of Medical Sciences
Full name of responsible person
Dr.Alireza Kouhpaei
Street address
Qom University of Medical Sciences,shahid Lavasani street,Qom,Iran
City
Qom
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qom University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Qom University of Medical Sciences
Full name of responsible person
Tahmineh Dadadkhah Tehrani
Position
MSc degree/ academic member
Other areas of specialty/work
Street address
Qom university of medical sciences,shahid Lavasani street, Qom,Iran
City
Qom
Postal code
3713649367
Phone
+98 25 3770 3736
Fax
Email
tdtahmineh@gmail.com; dadkhah-tehraniI@muq.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qom University of Medical Sciences
Full name of responsible person
Tahmineh Dadkhah tehrani
Position
MSc degree in midwifery/ academic member
Other areas of specialty/work
Street address
Qom university of medical sciences, shahid lavasani street. Qom, Iran
City
Qom
Postal code
3713649367
Phone
+98 25 3770 3736
Fax
Email
tdtahmineh@gmail.com; dadkhah-tehrani@muq.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Qom University of Medical Sciences
Full name of responsible person
Tahmineh Dadkhah Tehrani
Position
MSc degree/academic member
Other areas of specialty/work
Street address
Qom university of medical sciences ,shahid Lavasani street, Qom ,Iran
City
Qom
Postal code
3713649367
Phone
+98 25 3770 3736
Fax
Email
tdtahmineh@gmail.com; dadkhah-tehrani@muq.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)