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The effects of reflexology on pain and physiological indexes due to intrathecal (IT) chemotherapy drugs in children with cancer

Protocol summary

Study aim
The effect of reflexology on pain intensity and physiological indexes due to intratechal chemotherapy drugs in children with cancer.
Design
The study conducted as randomized clinical trial, with control group and single-blinded. The sample size included 70 subjects (35 the intervention group) and (35 the control group). The selection of two groups is based on lottery method.
Settings and conduct
This study conducted as single -blind in the Pediatric Hematology Department. In the intervention group, after controlling injection of intrathecal chemotherapy, the physiologic indexes and pain examined for 20 minutes before injection by the co- researcher. The foot massage conducted in two legs for 20 minutes by the researcher. While done intrathecal chemotherapy, pain and physiological indexes are investigated again by the co- researcher.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Having leukemia and have intrathecal chemotherapy drugs order, Having no seizure or any emergency disorders, Have not received any sedation and analgesic drugs before intervention, Have not received any foot- reflexology. Exclusion criteria: Not collaborating of child or family, Having physical disorders.
Intervention groups
Intervention group: Before injection of intrathecal chemotherapy drug, physiological indexes were checked. Then, a general massage and then a appropriative massage on the two-foot reflection points is performed for 20 minutes, ie10 minutes for each foot, , during a session immediately before the intrathecal injection. During the injection of the intrathecal chemotherapy drug, the physiological indexes and pain were examined. Control group: without reflexology, the physiological indexes and pain are examined for the same times.
Main outcome variables
Pain; physiological indexes

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20121025011261N3
Registration date: 2020-03-07, 1398/12/17
Registration timing: retrospective

Last update: 2020-03-07, 1398/12/17
Update count: 0
Registration date
2020-03-07, 1398/12/17
Registrant information
Name
Alia Jalalodini
Name of organization / entity
Nursing and Midwifery College
Country
Iran (Islamic Republic of)
Phone
+98 54 1244 2481
Email address
jalalodini@zaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-06-02, 1398/03/12
Expected recruitment end date
2019-11-03, 1398/08/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of reflexology on pain and physiological indexes due to intrathecal (IT) chemotherapy drugs in children with cancer
Public title
The effects of foot- reflexology on pain and physiological indexes due to intrathecal (IT) chemotherapy drugs
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having leukemia and have intrathecal chemotherapy drugs order. Having no seizure or any emergency disorders. Have not received any sedation and analgesic drugs before intervention. Have not received any foot- reflexology.
Exclusion criteria:
- Not collaborating of child or family - Having physical disorders
Age
From 6 years old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Outcome assessor
Sample size
Target sample size: 70
Randomization (investigator's opinion)
Randomized
Randomization description
Samples divided randomly into two groups; intervention group and control group. As, envelopes containing cards with numbers one and two are given to the participants, if the number one is chosen, they will be assigned to the intervention group. Otherwise they will be assigned to the control group.
Blinding (investigator's opinion)
Single blinded
Blinding description
The completion of questionnaires and the investigation of physiological indexes implemented by the researcher who, unawares of the allocation of the groups before and during intervention.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Zahedan University of Medical Sciences
Street address
Zahedan University of Medical Sciences, Janat Blvd
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816745477
Approval date
2019-08-11, 1398/05/20
Ethics committee reference number
IR.ZAUMS.REC.1398.169

Health conditions studied

1

Description of health condition studied
Pain
ICD-10 code
G89.1
ICD-10 code description
Acute pain, not elsewhere classified

2

Description of health condition studied
لوسمی حاد
ICD-10 code
C90.1
ICD-10 code description
Plasma cell leukemia

Primary outcomes

1

Description
The pain
Timepoint
20 minutes before and during injection of chemotherapy.
Method of measurement
The oucher scale

2

Description
Systolic and diastolic blood pressure
Timepoint
20 minutes before, and during intratechal injection of chemotherapy.
Method of measurement
Mercury pressure device with APK2 brand.

3

Description
Pulse
Timepoint
20 minutes before, and during intratechal injection of chemotherapy.
Method of measurement
The watch with mark Orient

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: 20 minutes before injection of intrathecal chemotherapy drug, physiological indexes were checked. Then, a general massage and then a appropriative massage on the two-foot reflection points is performed for 20 minutes, ie10 minutes for each foot, , during a session immediately before the intrathecal injection. During the injection of the intrathecal chemotherapy drug, the physiological indexes and pain were examined.
Category
Treatment - Other

2

Description
Control group: without reflexology, the physiological indexes and pain are examined in the determined times.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Ali Abne Abitaleb Hospital related to Zahedan University of Medical Sciences and Health Services
Full name of responsible person
Alia Jalalodini
Street address
Ali Abne Abitaleb Hospital, Health Blvd, Persian Gulf Highway, Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3341 9406
Fax
Email
a_jalalodini@yahoo.com
Web page address

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Dr. Normohammad Bakhshany
Street address
Zahedan University of Medical Sciences, Janat Blvd
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3329 5715
Email
histology@ymail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zahedan 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
Zahedan University of Medical Sciences
Full name of responsible person
Alia Jalalodini
Position
Faculty member of science, Master of science in nursing,
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Nursing and Midwifery Faculty، Behdasht Blvd,
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816913396
Phone
+98 54 3344 2482
Email
a_jalalodini@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Alia Jalalodini
Position
Faculty member of science, Master of science in nursing
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Nursing and Midwifery Faculty، Behdasht Blvd
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3344 2482
Email
a_jalalodini@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Alieh Jalalodini
Position
Faculty member of science, Master of science in nursing
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Nursing and Midwifery Faculty، Behdasht Blvd,
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3344 2481
Email
a_jalalodini@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
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