Protocol summary

Study aim
Determining and comparing the effect of acupressure and Hugo point massage with ice on pain intensity and physiological parameters induced by chemotherapy injection in children with acute lymphoblastic leukemia
Design
The clinical trial has two experimental and control groups, crossover, single blind, randomized, phase 1 on 52 patients. Four random blocks are used for randomization.
Settings and conduct
This study is performed in the blood and cancer ward of the Shahrivar Children's Educational and Medical Center in Rasht. In phase one, acupressure and ice massage interventions are performed in two groups, A and B. After one month and in the second phase, the intervention is transferred to two groups. In order to blind and prevent the effect of subjectivity on the research results, the interventions are performed by the main researcher and the consequences are measured by the researcher.
Participants/Inclusion and exclusion criteria
The study population was children 3-12 years old with acute lymphoblastic leukemia and treated with vincristine chemotherapy. Reluctance to cooperate and allergic response to chemotherapy are exclusion criteria.
Intervention groups
In phase one in the experimental group, the point of the hand Hugo where the injection is not performed, for one minute with a piece of ice (diameter 2 cm) wrapped in plastic gloves and a single layer of cotton cloth, with the fingertips, in the form of Rotate in a clockwise direction with an average pressure of 3 to 4 kg, so that the maximum pressure time of one minute and then 10 seconds of pressure is cut off and generally lasts for 5 minutes. In the acupressure group, only pressure is applied to the point.After one month of these interventions and in the second phase, the intervention will be transferred to two groups.
Main outcome variables
Intensity of pain, Percentage arterial blood oxygen saturation, heart rate (pulse)

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20110122005663N2
Registration date: 2021-11-09, 1400/08/18
Registration timing: prospective

Last update: 2021-11-09, 1400/08/18
Update count: 0
Registration date
2021-11-09, 1400/08/18
Registrant information
Name
Mahshid Mirzaie
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 13 3355 5056
Email address
mirzaie@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-11-26, 1400/09/05
Expected recruitment end date
2022-04-25, 1401/02/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effect of acupressure and massage with ice on Hugo’s point on pain and Physiological parameters related to chemotherapy drug injection in children with acute lymphoblastic leukemia, clinical trial
Public title
Comparison the effect of acupressure and massage with ice on Hugo’s point on pain and Physiological parameters related to chemotherapy drug injection in children with acute lymphoblastic leukemia, clinical trial
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Children aged 3-12 years With acute lymphoblastic leukemia One month has passed since the diagnosis Treated with Vincristine Chemotherapy Do not use the catheter port to prescribe chemotherapy No genetic or mental illness Organ health at the massage point Not receiving acupressure and ice massage at Hugo Point before the study Do not take painkillers 8 hours before chemotherapy injection
Exclusion criteria:
Reluctance to collaborate in the study Inadequate and severe mental and physical conditions
Age
From 3 years old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Outcome assessor
Sample size
Target sample size: 52
More than 1 sample in each individual
Number of samples in each individual: 2
In the first phase of the study, one group receives ice massage intervention and the other group receives acupressure intervention. Then, after one month and in the second phase, the intervention is transferred to two groups.
Randomization (investigator's opinion)
Randomized
Randomization description
Four random blocks will be used for random assignment of samples to two groups of ice massage at Hugo point (group A) and acupressure (group B). The number of blocks required in this study is 13 blocks, based on which random allocation will be done. The sequence of random assignment of samples to two groups of ice massage at Hugo point (group A) and acupressure (group B) is determined through Random allocation online software. The sequence list of samples A and B will be kept in a sealed envelope in the nursing office of 17 Shahrivar Hospital in Rasht. After starting the study, it will be opened by the main researcher and based on gradual referrals, children in one of groups A or B Will be located and will continue until the estimated sample size in each group is reached.
Blinding (investigator's opinion)
Single blinded
Blinding description
In order to blind the researcher and prevent the effect of mentality on the research results, acupressure and ice massage at Hugo point will be done by one of the members of the research team (main researcher) and the measurement of pain and physiological indicators will be done by the researcher.
Placebo
Not used
Assignment
Crossover
Other design features
The study method has two implementation phases. In the first phase, for group A, ice massage is performed at Hugo point and for group B, acupressure. Then, after a month of cleansing period, in the second phase, for group A, acupressure and for group B, ice massage is performed. The study is a crossover clinical trial.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Guilan University of Medical Sciences
Street address
Vice Chancellor for Research and Technology of Guilan University of Medical Sciences, in front of 17 Shahrivar hospital, Shahid Siadati Street, Namjoo Street.
City
Rasht
Province
Guilan
Postal code
4146939841
Approval date
2021-10-27, 1400/08/05
Ethics committee reference number
IR.GUMS.REC.1400.356

Health conditions studied

1

Description of health condition studied
Acute lymphoblastic leukemia
ICD-10 code
C91.0
ICD-10 code description
Acute lymphoblastic leukemia [ALL]

Primary outcomes

1

Description
Score of pain due to chemotherapy injection
Timepoint
Before the intervention, 5 seconds before the injection and 15 seconds after the injection of chemotherapy
Method of measurement
Oucher's pain intensity self-measurement scale

2

Description
Percentage of arterial blood oxygen saturation
Timepoint
Before the intervention, 5 seconds before the injection and 15 seconds after the injection of chemotherapy
Method of measurement
Pulse oximeter device

3

Description
Heart rate(pulse)
Timepoint
Before the intervention, 5 seconds before the injection and 15 seconds after the injection of chemotherapy
Method of measurement
Pulse oximeter device

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: In the first phase of the operation, in the intervention group, ice massage at the Hugo point is performed 5 minutes before the injection of chemotherapy by the main researcher for the child. To start the massage, first the child is placed on his back in a calm, comfortable and lying position. To determine the Hugo point, place the child's thumb in the abduction position, in which case, a prominent muscular peak (corresponding to the muscle approaching the thumb) located in the middle of the angle between the first and second bones of the palm, between the thumb and the finger. The point is on the back of the hand, the point is Hugo. Then place the hand Hugo point where the injection is not done, for one minute using a piece of ice (2 cm in diameter) wrapped in plastic gloves and a single layer of cotton cloth, using the soft part of the thumb in a rotating manner. , Press in a clockwise direction with an average pressure of 3 to 4 kg, so that the maximum pressure time is cut off one minute at a time and then 10 seconds, and lasts for a total of 5 minutes. Then, after one month and in the second phase of the implementation, acupressure intervention will be performed for this group.
Category
Other

2

Description
Control group: In the first phase, in the control group, Hugo point acupressure is performed by the principal investigator for the child 5 minutes before the chemotherapy drug is injected. To start work, first the child is placed on his back in a calm, comfortable and lying position. To determine the Hugo point, place the child's thumb in the abduction position, in which case, a prominent muscular peak (corresponding to the muscle approaching the thumb) located in the middle of the angle between the first and second bones of the palm, between the thumb and the finger. The point is on the back of the hand, the point is Hugo. Then press the hand Hugo point where the injection is not done, with the thumb, in a clockwise direction, with a deep pressure of 3 to 4 kg, so that the maximum pressure time per time The pressure is turned off for one minute and then for 10 seconds and lasts for a total of 5 minutes. After a month and in the second phase of the performance, an ice massage intervention will be performed at Hugo Point for this group.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Children 17 Shahrivar Educational and Medical Center in Rasht
Full name of responsible person
Saeed Sadat Mansouri
Street address
17 Shahrivar Children Educational and Medical Center, in front of the south side of Shahr Park, Shahid siadati Street, Namjoo Street.
City
Rasht
Province
Guilan
Postal code
4144654379
Phone
+98 13 3336 9019
Email
dr.s.s.mansouri@gums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Mohammad Reza Naghipour
Street address
Vice Chancellor for Research and Technology of Guilan University of Medical Sciences, in front of 17 Shahrivar hospital, Shahid Siadati Street, Namjoo Street.
City
Rasht
Province
Guilan
Postal code
4146939841
Phone
+98 13 3333 6394
Email
naghi@gums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rasht 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
Rasht University of Medical Sciences
Full name of responsible person
Mahshid Mirzaei Taklimi
Position
coach
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Shahid Beheshti School of Nursing and Midwifery, Daneshjoo Street, Beheshti Highway
City
Rasht
Province
Guilan
Postal code
4146939841
Phone
+98 13 3355 5056
Email
mahshidmirzaie2015@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Mahshid Mirzaei Taklimi
Position
coach
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Shahid Beheshti School of Nursing and Midwifery, Daneshjoo Street, Beheshti Highway
City
Rasht
Province
Guilan
Postal code
4146939841
Phone
+98 13 3355 5056
Email
mahshidmirzaie2015@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Mahshid Mirzaei Taklimi
Position
coach
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Shahid Beheshti School of Nursing and Midwifery, Daneshjoo Street, Beheshti Highway
City
Rasht
Province
Guilan
Postal code
4146939841
Phone
+98 13 3355 5056
Email
mahshidmirzaie2015@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
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