The aim of this study will be assessing the effect of foot reflexology on chemo-induced fatigue in patients with colorectal cancer
Design
Study with random allocation, uncontrolled, non-phase trial
Settings and conduct
Reflexology Massage Therapy by Chevalier on Chemo Therapy Patients with Cavernous Cancer in Imam Hossein Hospital
Participants/Inclusion and exclusion criteria
Benchmark: Patients diagnosed with colorectal cancer; Patients with a history of mental illness; Patients who do not use sedative medications; Patients with no leg-related disease: Diabetic neuropathy, Deep vein thrombosis, Patients with no spinal cord injury. Age over 18; Have read and write literacy; Patients do not have experience in the use of medicine; Patients do not have a history of chemotherapy in the past
Exit criteria: Patients with advanced and metastatic cancer
Intervention groups
The intervention group in this study is a patient with colorectal cancer whose fatigue criteria will be measured using the research tool. And receive reflective massage.
Control group In this study, patients with colorectal cancer whose fatigue criteria are measured using the research tool. And they will not receive any massages.
Main outcome variables
Fatigue
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170703034874N2
Registration date:2018-01-27, 1396/11/07
Registration timing:retrospective
Last update:2018-01-27, 1396/11/07
Update count:0
Registration date
2018-01-27, 1396/11/07
Registrant information
Name
Mohammad Moradi Akbari
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8872 6629
Email address
m.moradiakbari@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2017-07-23, 1396/05/01
Expected recruitment end date
2017-10-23, 1396/08/01
Actual recruitment start date
2017-10-07, 1396/07/15
Actual recruitment end date
2017-12-20, 1396/09/29
Trial completion date
empty
Scientific title
The effects of foot reflexology on fatigue among cancer patients undergoing chemotherapy
Public title
The effects of foot reflexology on fatigue among cancer patients undergoing chemotherapy
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patients diagnosed with colon rectal cancer
Patients do not have a history of mental illness
Patients who do not use sedative medications
Patients with no leg-related disease:
Patients with deep vein thrombosis
Patients with no spinal cord injury
Age over 18 years
Patients do not have a history of using complementary medicine
Patients do not have a history of chemotherapy in the past
Patients who are not diabetic neuropathy
Have the ability to read and write
Exclusion criteria:
Patients with advanced and metastatic cancer
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Actual sample size reached:
60
Randomization (investigator's opinion)
Randomized
Randomization description
In this research, convenience sampling method and random allocation method were used. Researchers went to selected centers daily and using random numbers table, the study samples were allocated to groups A or B. This process continued until 30 samples per group and a total of 60 samples were obtained.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shahid Beheshti University of Medical Sciences
Street address
Iran, Tehran Velenjak St. , Shahid Chamran Highway
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2016-10-24, 1395/08/03
Ethics committee reference number
IR-SBMU.PHNM.1395.530
Health conditions studied
1
Description of health condition studied
Colorectal cancer
ICD-10 code
c18
ICD-10 code description
Malignant neoplasm of anus and anal canalc18Malignant neoplasm of colon, c19Malignant neoplasm of rectosigmoid junction, c20Malignant neoplasm of rectum, c21
Primary outcomes
1
Description
Fatigue
Timepoint
Before intervention, after intervention
Method of measurement
Florida inventory for fatigue symptom and Piper Fatigue Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
In the intervention group, foot reflexology massage will be performed in 4 courses of chemotherapy in patients with colorectal cancer and the fatigue will be measured before and after each massage. At the end of the work, these two groups will be compared, ie, intervention and control
Category
Treatment - Other
2
Description
Control group: routine care was performed and before and after each chemotherapy simultaneously with the massage, the fatigue was measured
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Hosein Hospital
Full name of responsible person
Mohammad Moradi Akbari
Street address
Tehran Emem Hosein squ Emam Hosein Hospital
City
Tehran
Province
Tehran
Postal code
1431874181
Phone
Email
hamedi_06@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Shahid Beheshti University of Medical Sciences
Street address
Iran, Tehran Velenjak St. , Shahid Chamran Highway
City
Tehran
Province
Tehran
Postal code
1431874181
Email
hamedi_06@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Persons
Person responsible for general inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mohammad Moradi Akbari
Position
ms student
Latest degree
Bachelor
Other areas of specialty/work
Street address
Iran, Tehran Velenjak St. , Shahid Chamran Highway
City
tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8820 2521
Fax
Email
m.moradiakbari@sbmu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mohammad Moradi Akbari
Position
master of science
Latest degree
Bachelor
Other areas of specialty/work
Street address
Iran, Tehran Velenjak St. , Shahid Chamran Highway
City
tehran
Province
Tehran
Postal code
1431874181
Phone
+98 21 8820 2521
Fax
Email
m.moradiakbari@sbmu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mohammad Moradi Akbari
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Nikan Hospital, 22 Bahaman st , Artesh st
City
Tehran
Province
Tehran
Postal code
1431874181
Phone
+98 21 2912 1427
Email
hamedi_06@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