Determine the effect of maternal foot massage on the severity of attention deficit / hyperactivity disorder symptoms in children aged 12-6 years
Design
A single blinded clinical trial with a control and intermediate group, with pre and post test designs, with 56 children with attention deficit hyperactivity disorder
Settings and conduct
A randomized clinical trial was conducted. A total of 56 patients referred to Isfahan University of Medical Sciences affiliated Clinics were randomly assigned to control and test groups.Test group was referred to Al-Zahra Hospital for learning massage therapy, and it was taken at home three times in the week is for one month and the control group is unaware of the massage and the study is single blinded.
Participants/Inclusion and exclusion criteria
Inclusion criteria: At least six months have passed since diagnosis.
There is no other psychiatric illness.
Inclination to participate in the study and to be randomly assigned to the study groups.
Do not simultaneously participate in another similar study.
There is no specific problem, such as fractures, infections, or ulcers, and any factors that prevent full access to the legs
Exclusion criteria: Use of therapeutic behavior along with drug therapy
Intervention groups
The intervention group learns massage in a one course and they do it three times a week for one month.The control group receives routine care.
Main outcome variables
The general score of severity of attention deficit / hyperactivity disorder symptoms
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181224042090N1
Registration date:2019-02-03, 1397/11/14
Registration timing:prospective
Last update:2019-02-03, 1397/11/14
Update count:0
Registration date
2019-02-03, 1397/11/14
Registrant information
Name
Zahra Asadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3447 6269
Email address
z_asadi4838@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-02-09, 1397/11/20
Expected recruitment end date
2019-03-11, 1397/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of maternal foot massage on the severity of symptoms of attention deficit hyperactivity disorder in children aged 6-12
Public title
The effect of foot massage on the severity of attention deficit / hyperactivity disorder symptoms
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
At least six months have passed since diagnosis.
There is no other psychiatric illness.
Willing to participate in the study.
Do not participate in the same study at the same time.
There is no specific problem, such as fractures, infections, or ulcers, and any factors that Impede full access to the legs.
Exclusion criteria:
Use of therapeutic behavior along with drug therapy
Age
From 6 years old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
56
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method and description of each method: Simple randomization: Children's files were numbered from 1 to 56, each number was recorded in a separate sheet and all the sheets were poured into the container after being placed in a container. After shaking the container, a sheet was removed, respectively, the first sheet was placed in the intervention group and the second sheet in the control group.
Random unit: Individual
Randomization Tool: Folded sheets in the bag
Blinding (investigator's opinion)
Single blinded
Blinding description
The group was not aware of the lack of simultaneous receiving of massage training in the control group. After the intervention, the massage program was given to the control group
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences, Faculty of Nursing and Midwifery
City
Esfahan
Province
Isfehan
Postal code
8149868561
Approval date
2019-01-10, 1397/10/20
Ethics committee reference number
IR.MUI.RESEARCH.REC.1397.305
2
Ethics committee
Name of ethics committee
Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences, Faculty of Nursing and Midwifery
City
Esfahan
Province
Isfehan
Postal code
8149868561
Approval date
2019-01-10, 1397/10/20
Ethics committee reference number
1397.305
Health conditions studied
1
Description of health condition studied
Attention-deficit hyperactivity disorder
ICD-10 code
F90.2
ICD-10 code description
Attention-deficit hyperactivity disorder, combined type
Primary outcomes
1
Description
Severity of attention deficit / hyperactivity symptoms
Timepoint
Before the start of the study and 30 days after the intervention began