Investigating the effect of acupressure on the amount and intensity of nausea, vomiting and the level of comfort of children with leukemia undergoing chemotherapy
Determining the effect of acupressure on the amount and severity of nausea, vomiting and the level of comfort of children with leukemia undergoing chemotherapy
Design
Intervention
Settings and conduct
Ekbatan Hospital affiliated to Hamadan University of Medical Sciences
Participants/Inclusion and exclusion criteria
Children 6-12 years old with leukaemia Under chemotherapy Treated with a fixed dose of chemotherapy Not having digestive diseases
Intervention groups
Intervention group: Acupressure wristband group: First, the P6 point on the left hand is closed on the inner side of the forearm, in the cavity between the bones of the forearm, with a distance of three fingers above the fold of the wrist, then the wristband is fixed on the P6 point with a push button for 30 minutes. to be able to press the mentioned point. This intervention is performed 30 minutes before chemotherapy and then 30 minutes before breakfast, lunch and dinner on the first, second and third day after chemotherapy and each time for 30 minutes.
Main outcome variables
Nausea and vomiting and patient comfort
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190703044082N10
Registration date:2024-07-04, 1403/04/14
Registration timing:registered_while_recruiting
Last update:2024-07-04, 1403/04/14
Update count:0
Registration date
2024-07-04, 1403/04/14
Registrant information
Name
Fateme Mohammadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 81 4567 8904
Email address
f-mohammadi@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-05-20, 1403/02/31
Expected recruitment end date
2024-07-21, 1403/04/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of acupressure on the amount and intensity of nausea, vomiting and the level of comfort of children with leukemia undergoing chemotherapy
Public title
Investigating the effect of acupressure on the amount and intensity of nausea, vomiting and the level of comfort of children with leukemia undergoing chemotherapy
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Children 6-12 years old with leukaemia Under chemotherapy Treated with a fixed dose of chemotherapy Not having digestive diseases
Exclusion criteria:
Age
From 6 years old to 12 years old
Gender
Both
Phase
1
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
111
Randomization (investigator's opinion)
Randomized
Randomization description
To randomly assign the participants to the acupressure, placebo and control groups, the names of the three groups will be written on paper and taken randomly, and the order of sampling of the groups will be determined. 20 blocks of 6 will be used for random allocation of samples in three groups. In this way, the letter A will be considered for the acupressure group, the letter B for the placebo group, and the letter C for the control group. on pieces of paper, and we will pick them randomly. Then, according to the possible order of sampling, it will start.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients are blinded to the allocation of which group they will be placed in. That is, children and their families are unaware of whether they have been placed in the acupressure, placebo and control groups. In addition, the person who collected the data is blinded to the assignment of individuals to groups
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research ethics committee of Hamadan University of Medical Sciences
Street address
Beginning of Ayatollah Kashani Boulevard, Hamadan University of Medical Sciences and Health Services
City
Hamadan
Province
Hamadan
Postal code
6817838698
Approval date
2024-07-01, 1403/04/11
Ethics committee reference number
IR.UMSHA.REC.1403.198
Health conditions studied
1
Description of health condition studied
leukemia
ICD-10 code
C91
ICD-10 code description
Lymphoid leukemia
Primary outcomes
1
Description
frequency and severity of nausea and vomiting
Timepoint
Before chemotherapy and at the end of the first, second and third day after chemotherapy
Method of measurement
Rhodes Nausea and Vomiting Index adapted for children by parents
2
Description
Patient comfort
Timepoint
Before chemotherapy and at the end of the first, second and third day after chemotherapy
Method of measurement
visual analog scale (VAS)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Acupressure wristband group: First, the P6 point on the left hand is closed on the inner side of the forearm, in the cavity between the bones of the forearm, with a distance of three fingers above the fold of the wrist, then the wristband is fixed on the P6 point with a push button for 30 minutes. to be able to press the mentioned point. This intervention is performed 30 minutes before chemotherapy and then 30 minutes before breakfast, lunch and dinner on the first, second and third day after chemotherapy and each time for 30 minutes.
Category
Treatment - Other
2
Description
Placebo group: wristband without push button is used. For this purpose, point P6 is determined and the wristband is closed 30 minutes before chemotherapy and then 30 minutes before breakfast, lunch and dinner on the first, second and third day after chemotherapy and each time for 30 minutes for people in this group.
Category
Placebo
3
Description
Control group: Control group: Wristbands are not used for this group. The level and severity of nausea, vomiting and comfort level of children before chemotherapy (T0), at the end of the first day (T1), at the end of the second day (T2) and at the end of the day. The third (T3) is asked and recorded by the researcher's assistant at 12:00 noon and night.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Ekbatan Hospital affiliated to Hamadan University of Medical Sciences
Full name of responsible person
Fateme Mohammadi
Street address
Beginning of Ayatollah Kashani Boulevard, Hamadan University of Medical Sciences and Health Service
City
Hamedan
Province
Hamadan
Postal code
6517838698
Phone
+98 81 3334 5634
Email
mohammadifateme47@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Reza Shokoohi
Street address
Beginning of Ayatollah Kashani Boulevard, Hamadan University of Medical Sciences and Health Services
City
Hamedan
Province
Hamadan
Postal code
6517838698
Phone
+98 81 3334 5634
Email
F-mohammadi@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Private
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
Hamedan University of Medical Sciences
Full name of responsible person
Fateme Mohammadi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Beginning of Ayatollah Kashani Boulevard, Hamadan University of Medical Sciences and Health Services
City
Hamedan
Province
Hamadan
Postal code
6517838698
Phone
+98 81 3334 5634
Email
mohammadifateme47@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Fateme Mohammadi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Beginning of Ayatollah Kashani Boulevard, Hamadan University of Medical Sciences and Health Services
City
Hamedan
Province
Hamadan
Postal code
6517838698
Phone
+98 81 3334 5634
Email
mohammadifateme47@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Fateme Mohammadi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Beginning of Ayatollah Kashani Boulevard, Hamadan University of Medical Sciences and Health Services
City
Hamedan
Province
Hamadan
Postal code
6517838698
Phone
+98 81 3334 5634
Email
ئخاشئئشیهبشفثئث47@yahoo.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