This research is a single-blind randomized controlled clinical trial study. The sample size will be 120 children between the ages of 8 and 12, who randomly divided to experimental and placebo groups. Subjects shouldn't have prior experience of acupressure and anticipated survival will be more than 3 months and Patients will excluded if they had low platelet count (<50,000); suffered from a bleeding disorder (e.g. hemophilia). Routine care was administered to the both groups. at pre-intervention, in the second day of chemotherapy, nausea and fatigue intensity will be measure by Visual Analogue Scales Then the intervention (finger acupressure) will apply for 3 minutes on P6 and ST36 (true points) in the experimental group, and on LI12 and SI3 (sham points) in the placebo group. We will evaluate the symptoms of nausea and fatigue intensity immediately and one hour after the intervention. Then the variable of nausea/vomiting and fatigue will measure at 12 and 24 hours after the intervention by the instruments of Adapted Rhodes Index of Nausea and Vomiting for Pediatrics by Child (ARINVc) and Fatigue Scale Child (FSC).
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201104216247N1
Registration date:2012-04-19, 1391/01/31
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-04-19, 1391/01/31
Registrant information
Name
Farideh Bastani
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8857 2278
Email address
f-bastani@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2010-08-11, 1389/05/20
Expected recruitment end date
2010-12-26, 1389/10/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
effect of acupressure on chemotherapy-induced nausea, vomiting and fatigue among school aged children with acute lymphoblastic leukemia
Public title
efficacy of acupressure on chemotherapy-induced nausea, vomiting and fatigue
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:no prior experience of acupressure, anticipated survival more than 3 months, no chronic disease.
Exclusion criteria: Patients will excluded if they had low platelet count (<50,000); suffered from a bleeding disorder (e.g. hemophilia).
Age
From 8 years old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Sciences
Street address
Tohid square, Tehran
City
Tehran
Postal code
Approval date
2010-07-03, 1389/04/12
Ethics committee reference number
1744263
Health conditions studied
1
Description of health condition studied
leukemia
ICD-10 code
C91
ICD-10 code description
Lymphoid leukaemia
Primary outcomes
1
Description
nausea/vomiting
Timepoint
12 hours after the intervention
Method of measurement
Adapted Rhodes Index of Nausea and Vomiting for Pediatrics by Child (ARINVC)
2
Description
fatigue
Timepoint
24 hours after the intervention (acupressure)
Method of measurement
Fatigue Scale Child(FSC)
Secondary outcomes
empty
Intervention groups
1
Description
For the intervention group, the intervention regarding the variable of fatigue, was acupressure with duration of 3 minutes for once on the point of ST36 and for the variable of nausea and vomiting was P6 respectively.
Category
Treatment - Other
2
Description
For the control group, the intervention regarding the variable of fatigue, was touch with duration of 3 minutes for once on the point of LI12 and for the variable of nausea and vomiting was S13 respectively.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Ali Asghar Children Hospital
Full name of responsible person
Street address
Zafar street,Tehran
City
Tehran
2
Recruitment center
Name of recruitment center
Children Medical Center
Full name of responsible person
Street address
Dr Gharib Street,Tehran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Mohamad Ali Cheraghi
Street address
Nosrat street,Tohid Sq,Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?