Determine the effect of foot reflexology on anorexia and quality of sleep in patients undergoing chemotherapy
Design
Clinical trial with control group, Blind, randomized, with 60 patients
Settings and conduct
In this study will be selected 60 patients suffering from cancer hospitalized in the hematology and oncology departments of Ayatollah Khansari hospital in arak city and with random blocks will be divided to two groups of experimental and control. In the intervention group, patients takes 8 reflexology sessions twice a week for 4 weeks. Each session is 15 minutes massage for each leg, control group during this period twice a week for 4 weeks, upper surface of each leg 15 minutes without pressure will be touched.The questionnaires before and after 30 days will be completed for both groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria:a) age between 30-60 years old; b) being chemotherapy for at least one period; c) stages 2,3 or 4 of cancer. Exclusion criteria: a) Lack of Literacy; b) Non-treatable cancer.
Intervention groups
In the intervention group, patients takes 8 reflexology sessions twice a week for 4 weeks. Each session is 15 minutes massage for each leg, and includes 5 minutes for general massage of the foot and 10 minutes for massage on the pituitary gland, hypothalamus, pineal gland on the finger foot thumb and gastrointestinal tract (stomach, liver, small intestine). In the control group, patients do not receive any reflexology intervention and for unify the interventions, twice a week for 4 weeks, upper surface of each leg
15 minutes without pressure will be touched.
Main outcome variables
Sleep quality; anorexia
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130424013110N8
Registration date:2019-08-27, 1398/06/05
Registration timing:registered_while_recruiting
Last update:2019-08-27, 1398/06/05
Update count:0
Registration date
2019-08-27, 1398/06/05
Registrant information
Name
Mehdi Harorani
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 3417 3505
Email address
m.harorany@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-07-23, 1398/05/01
Expected recruitment end date
2019-11-22, 1398/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of foot reflexology on anorexia and quality of sleep in patients undergoing chemotherapy: a randomized clinical trial
Public title
The effect of foot reflexology on anorexia and quality of sleep in patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 30-60 years old
Experience of at least one period of chemotherapy
Absence of psychological or known cognitive disease
Stages 2,3 & 4 of cancer
Exclusion criteria:
Lack of literacy
Non-treatable cancer
The presence of deformity burn or ulcer in the areas of massage on the palms of the feet
Use of hypnotic and sedative drugs
Use of other complementary and alternative methods during the study.
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be by using random blocks.
Blinding (investigator's opinion)
Double blinded
Blinding description
Individuals with entry criteria are divided into intervention and control groups according to the random numbers table. One of the groups is A and the other is called B. Before and after the intervention, the information is collected by the evaluator of the outcome that is unaware of the Classification of the groups. Data analysis is also done by someone who is unaware of the allocation of groups. The control group also receive similar (but not effective) intervention so are unaware of the allocation to the intervention or control group.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Arak University of Medical Sciences
Street address
Vice Chancellery For Research And Education, Pardis Site Of University Of Medical Sciences, Basij Sq, Arak
City
Arak
Province
Markazi
Postal code
38481-76941
Approval date
2019-06-23, 1398/04/02
Ethics committee reference number
IR.ARAKMU.REC.1398.095
Health conditions studied
1
Description of health condition studied
Cancer
ICD-10 code
C80
ICD-10 code description
Malignant neoplasm without specification of site
Primary outcomes
1
Description
Sleep Quality
Timepoint
Before and 30 days after the intervention
Method of measurement
SMHSQ Sleep Quality Questionnaire
2
Description
Anorexia
Timepoint
Before and 30 days after the intervention
Method of measurement
Anorexia questionnaire with Visual Analog Scale (VAS)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In the intervention group, patients takes 8 reflexology sessions twice a week for 4 weeks.
Category
Other
2
Description
Control group: in the control group, patients do not receive any reflexology intervention and for unify the interventions, twice a week for 4 weeks, upper surface of each leg 15 minutes without pressure will be touched.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Khansari hospital, Arak
Full name of responsible person
Mehdi Harorani
Street address
Daneshgah Avenue
City
Arak
Province
Markazi
Postal code
38149 - 75585
Phone
+98 86 3367 5001
Email
m.harorani@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Alireza Kamali
Street address
Vice Chancellery For Research And Education, Pardis Site Of University Of Medical Sciences, Basij Sq, Arak
City
Arak
Province
Markazi
Postal code
38481-76941
Phone
+98 86 3417 3503
Email
m.harorani@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University of Medical Sciences
Full name of responsible person
Mehdi Harorani
Position
Academic Instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Pardis Site Of University Of Medical Sciences, Basij Sq, Arak
City
Arak
Province
Markazi
Postal code
38481-76941
Phone
+98 86 3417 3503
Fax
Email
m.harorani@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mehdi Harorani
Position
Academic Instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Pardis Site Of University Of Medical Sciences, Basij Sq, Arak
City
Arak
Province
Markazi
Postal code
38481-76941
Phone
+98 86 3417 3503
Email
m.harorani@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mehdi Harorani
Position
Academic instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Pardis Site Of University Of Medical Sciences, Basij Sq, Arak
City
Arak
Province
Markazi
Postal code
38481-76941
Phone
+98 86 3417 3503
Email
m.harorani@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