Determining the effect of hand and foot reflexology therapy on radiotherapy fatigue in cancer patients
Design
A clinical trial, without blinding, with three parallel groups (2 intervention groups and one control group), 90 outpatients
Settings and conduct
This is a single-blind clinical trial study in which the participant does not know which intervention or control group he or she belongs to. The research environment of this study is the radiotherapy department of Imam Hossein Educational and Medical Center affiliated to Shahid Beheshti University of Medical Sciences.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Willing to participate in the study; The subjects should be able to read and complete the questionnaire; Men and women 18 years and older; Cancer patients who have been prescribed radiotherapy; No mental disorders under treatment, according to the patient; No history of taking psychiatric drugs; No diabetes; Absence of hand or foot disease and problems such as vascular disorders and amputation; Not using complementary medicine in the last few weeks
Intervention groups
Two intervention groups: In the first intervention group, patients receive hand reflexology massage therapy and the second group receive foot reflexology massage therapy.
Control group: In the control group, which is the third group, patients receive routine care and reflexology massage is not performed on them.
Main outcome variables
fatigue
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210623051684N1
Registration date:2022-02-17, 1400/11/28
Registration timing:registered_while_recruiting
Last update:2022-02-17, 1400/11/28
Update count:0
Registration date
2022-02-17, 1400/11/28
Registrant information
Name
Fozieh Zoghi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6119 2534
Email address
fozieh.zoghi@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-01-26, 1400/11/06
Expected recruitment end date
2022-05-20, 1401/02/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Hand and Foot Reflexology on Fatigue Induced by Radiotherapy in Patients with Cancer
Public title
The Effect of Hand and Foot Reflexology on Fatigue Induced by Radiotherapy in Patients with Cancer
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Have a desire to participate in the study.
The subjects should be able to read and complete the questionnaire.
Men and women 18 years and older
Cancer patients who have been prescribed radiotherapy
Exclusion criteria:
Have mental disorders according to the patient who is being treated.
History of using psychiatric drugs
Have diabetes
Hand or foot diseases and problems such as vascular disorders and amputation
Using complementary medicine in the last few weeks
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
In this research, goal-based sampling and random allocation methods are used. After selecting 90 patients who met the appropriate criteria for inclusion in the study. Each patient receives a number and then, using a table of random numbers, it is determined which of the three groups (2 intervention groups and one control group) should be included in the study samples, respectively. They are included in the study groups in the order of enrollment and according to the table. A table of random numbers with a number of 30 random blocks is used. Thus, from this table, 3 consecutive blocks (Tables 1 to 3) are randomly selected. Each block contains 30 random numbers from 0 to 29. Look at each of the numbers from left to right. Random numbers 0 to 9 in group 1, numbers 9 to 19 in group 2, and numbers 20 to 29 in group 3. Placed. Based on this random table, it was determined in which group each patient should be included in the order of enrollment.
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
Ethics Committee of Shahid Beheshti University of Medical Sciences
Street address
Valiasr St., Amir Bahador Bridge, Moqarrabi St., No. 40
City
Tehran
Province
Tehran
Postal code
1334994431
Approval date
2020-10-24, 1399/08/03
Ethics committee reference number
IR.SBMU.PHARMACY.REC.1399.291
Health conditions studied
1
Description of health condition studied
Cancer
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
fatigue
Timepoint
The beginning of the study and the week after the intervention
Method of measurement
Fatigue Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The first group to receive reflexology massage therapy
Category
Other
2
Description
Intervention group: The second group who receive foot reflexology massage
Category
Other
3
Description
Control group: The third group receives only routine care and no reflexology massage
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Hossein Hospital
Full name of responsible person
Fozieh Zoghi
Street address
Valiasr St., Amir Bahador Bridge, Moqarrabi St., No. 40
City
Tehran
Province
Tehran
Postal code
1334994431
Phone
+98 21 6119 2534
Email
fozieh.zoghi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Afshin Zarghi
Street address
Valiasr St., Amir Bahador Bridge, Moqarrabi St., No. 40
City
Tehran
Province
Tehran
Postal code
1334994431
Phone
+98 21 6119 2534
Email
fozieh.zoghi@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
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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Fozieh Zoghi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Valiasr St., Amir Bahador Bridge, Moqarrabi St., No. 40
City
Tehran
Province
Tehran
Postal code
1334994431
Phone
+98 21 6119 2534
Email
fozieh.zoghi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Fozieh Zoghi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Valiasr St., Amir Bahador Bridge, Moqarrabi St., No. 40
City
Tehran
Province
Tehran
Postal code
1334994431
Phone
+98 21 6119 2534
Email
fozieh.zoghi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Fozieh Zoghi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Valiasr St., Above Amir Bahador Bridge, Moqarrabi St., No. 40
City
Tehran
Province
Tehran
Postal code
1334994431
Phone
02161190
Email
fozieh.zoghi@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Part of the data, such as information about the main outcome, can be shared
When the data will become available and for how long
Start access 6 months after printing results
To whom data/document is available
Researchers working in academic and scientific institutions and people who are medical staff
Under which criteria data/document could be used
For further research by researchers and the use of medical staff to improve the quality of life of patients
From where data/document is obtainable
fozieh.zoghi@yahoo.com
What processes are involved for a request to access data/document