The Effect of Foot Reflexology on Quality of Life in Patients with Chemotherapy-Induced Neuropathy in Colorectal Cancer who Admitted in Emam Hossein Hospital at Shahid Beheshti University of Medical Sciences in 1396
The aim of this study was to investigate the effect of foot reflexology massage on the quality of life of patients with chemotherapy induced neuropathy in colorectal cancer patients admitted to Imam Hossein Hospital affiliated to Shahid Beheshti University of Medical Sciences
Study Design: This study is an interventional and experimental.
Study population: Patients with cancer who referred to Imam Hossein Hospital's oncology department
Major entry criteria: Patients with colorectal cancer who are chemically treated with the specified regimens (taksans, platinum compounds, and vinca alkaloids).
The diagnosis of colorectal cancer is done by a pathologist and cancer specialist.
Neuropathy is diagnosed by a cancer specialist.
Main criteria for withdrawal:
Cause of any complications and illness in the patient's legs during the study
Acute infectious diseases during the study
Dismissing the patient and losing the research sample
Sample size: 80
Intervention: Foot reflexology
Time of intervention: Performing foot reflexology massage for 10 minutes for each leg and a total of 20 minutes for both legs in 4 periods of chemotherapy at intervals of 2 weeks
Primary outcomes or outcomes of the study: Improving the quality of life
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017021632607N1
Registration date:2017-08-04, 1396/05/13
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-08-04, 1396/05/13
Registrant information
Name
Hesam Gholamzadeh
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 938 413 0204
Email address
he.gholamzadeh@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
According to Shahid Beheshti University of Medical Sciences regulations
Expected recruitment start date
2017-08-23, 1396/06/01
Expected recruitment end date
2018-02-20, 1396/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Foot Reflexology on Quality of Life in Patients with Chemotherapy-Induced Neuropathy in Colorectal Cancer who Admitted in Emam Hossein Hospital at Shahid Beheshti University of Medical Sciences in 1396
Public title
The Effect of Foot Reflexology on Quality of Life
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Patients with colorectal cancer who are chemically treated with the specified regimens (taksans, platinum compounds, and vinca alkaloids);
The diagnosis of colorectal cancer is done by a pathologist and cancer specialist;
Neuropathy is diagnosed by a cancer specialist.
Exclusion criteria:
Cause of any complications and illness in the patient's legs during the study;
Acute infectious diseases during the study;
Dismissing the patient and losing the research sample.
Age
From 18 years old to 99 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
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, Faculty of Nursing and Midwifery
Street address
Shahid Beheshti University of Medical Sciences, Faculty of Nursing and Midwifery, Niayesh Crossroad, Vali Asr avenue, Tehran, Iran
City
Tehran
Postal code
Approval date
2017-07-01, 1396/04/10
Ethics committee reference number
IR.SBMU.PHNM.1396.773
Health conditions studied
1
Description of health condition studied
Colon and Rectum cancer
ICD-10 code
C19, C20,
ICD-10 code description
Malignant neoplasm of rectosigmoid junction, Malignant neoplasm of anus and anal canal, Malignant neoplasm of rectum
Primary outcomes
1
Description
Quality of life
Timepoint
Before the intervention and at the next session immediately before the intervention, the questionnaires will be completed by the test group.
Method of measurement
European Organisation for Research and Treatment of Cancer quality of life questionnaries
Secondary outcomes
empty
Intervention groups
1
Description
For intervention group, 4 sessions (two steps), foot reflexology massage (massage techniques and foot exercises) for 20 minutes, two weeks apart.
Category
Lifestyle
2
Description
The control group will receive standard cares of center.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Hossein medical and educational center
Full name of responsible person
Mahnaz Ilkhani, Ph.D. in Nursing, Assistant Professor