The effect of acupressure on fatigue in cancer patients undergoing chemotherapy referred to educational and therapeutic center - Guilan University of Medical Sciences in 2014
Objective:The purpose of this study was to determine the effect of acupressure on fatigue in patients undergoing chemotherapy.
Design: The study is a randomized clinical trial that included 90 patients with cancer Setting : patients with cancer who present in one of the hospitals of Guilan University of medical sciences
Inclusion criteria : consciousness؛ lack of amputation؛ II, III, and IV stages of cancer؛ Chemotherapy at least in the past month ؛ lack of ulcer at the acupoints ؛ complaint of fatigue ( moderate to high) ؛ Having hemoglobin less than 12 mg /dl
Intervention :Samples using random sampling in 3 blocks of 30 samples , a group of acupressure on fatigue, fatigue placebo group and a group given routine care.In this study the researcher to sample the oncology department of the educational center - referred Guilan University of Medical Sciences and the patient meets.After explaining the purpose and procedures for patients if these patients have a willingness to participate in the research.Consent form is completed for them.The same characteristics in terms of age, sex and chemotherapy sessions in three groups of sources and expert opinion acupressure points in the intervention group L14The middle half of the angle between the first and second metacarpal),) SP64 middle finger above the ankle and the tibia of the legs), ST36 (one finger width outside edge of the inferior tibial tuberosity and 4 fingers below the knee)) to reduce fatigue anywhere for 1 minute, once during and once after completion of chemotherapy, chemotherapy is done.In the placebo group over a distance of 1.5 cm from the main point is pressed and the control group were given routine care.Fatigue before and after the acupressure (during chemotherapy and after chemotherapy) were measured .
Main outcome measure: Fatigue Scale questionnaire in three stages (before chemotherapy, during chemotherapy, after chemotherapy) is collected and measured
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201207141174N9
Registration date:2014-12-28, 1393/10/07
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-12-28, 1393/10/07
Registrant information
Name
Atefeh Ghanbari
Name of organization / entity
Guilan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 13780509
Email address
at_ghanbari@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
vice chancellor for research,Guilan University of medical Sciences
Expected recruitment start date
2014-03-20, 1392/12/29
Expected recruitment end date
2015-02-19, 1393/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of acupressure on fatigue in cancer patients undergoing chemotherapy referred to educational and therapeutic center - Guilan University of Medical Sciences in 2014
Public title
Effect of acupressure on fatigue in cancer patients
Purpose
Supportive
Inclusion/Exclusion criteria
inclusion criteria: consciousness؛ lack of amputation؛ II, III, and IV stages of cancer؛ Chemotherapy at least in the past month ؛ lack of ulcer at the acupoints ؛ complaint of fatigue ( moderate to high) ؛ Having hemoglobin less than mg / dl12
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
In this study, the balanced block randomization will be used and the patients allocated in three groups; intervention group (acupressure on the correct acupoints), placebo group (acupressure on the sham acupoints) and control group (routine cares). Acupressure will be conducted (as single-blind) on the correct and sham acupoints in two groups of intervention and placebo. So the patients will be not informed about the kind of acupressure.
Secondary Ids
1
Registry name
no
Secondary trial Id
no
Registration date
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical committee of Vice Chancellor for Research and Technology, Guilan University university of M
Street address
Research and Technology affairs building , infront of Bank Sepah , over of iran radiator , West Beheshti Boulevard ,Rasht
City
Rasht
Postal code
41469-39841
Approval date
2014-09-30, 1393/07/08
Ethics committee reference number
293033037
Health conditions studied
1
Description of health condition studied
cancer
ICD-10 code
COO,C97,C7
ICD-10 code description
Malignant neoplasms,Malignant neoplasms of ill-defined, secondary and unspecified sites
Primary outcomes
1
Description
Fatigue
Timepoint
Before the intervention,After intervention during chemotherapyAfter the intervention after chemotherapy
Method of measurement
Fatigue Inventory(FSS)
Secondary outcomes
1
Description
no
Timepoint
no
Method of measurement
no
Intervention groups
1
Description
Intervention group: the intervention group on the 3-point acupressure true will done for 1 min and only one time during chemotherapy and one time after completed chemotherapy
Category
Other
2
Description
Placebo: in the placebo acupressure points on 3-point lies close to true for 1 minute, once during and once after completing of chemotherapy
Category
Other
3
Description
Control group: The control group will receive routine care of patients.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Razi Hospital
Full name of responsible person
Atefeh Ghanbari
Street address
Nursing and Midwifery School,St. student, Beheshti Highway , Rasht
City
Rasht
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research and Technology, Guilan University of Medical Sciences
Full name of responsible person
Abtin Heidar zadeh
Street address
Research and Technology affairs building , infront of Bank Sepah , over of iran radiator , West Beheshti Boulevard ,Rasht
City
Rasht
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research and Technology, Guilan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Atefeh Ghanbari
Position
PHD
Other areas of specialty/work
Street address
Nursing and midwiffery school, St Student , Beheshti Highway, Rasht
City
Rasht
Postal code
39841-41469
Phone
+98 13 3355 3202
Fax
+98 13 3355 0097
Email
at_ghanbari@gums.ac.ir
Web page address
www.gums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Atefeh Ghanbari
Position
PHD
Other areas of specialty/work
Street address
Nursing and Midwifery School , St Student, Beheshti Highway, Rasht
City
Rasht
Postal code
39841-41469
Phone
+98 13 3355 3202
Fax
+98 13 3355 0097
Email
at_ghanbari@gums.ac.ir
Web page address
www.gums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Atefeh Ghanbari
Position
PHD
Other areas of specialty/work
Street address
Nursing and Midwifery School, St Student , Beheshti Highway, Rasht
City
Rasht
Postal code
39841-41469
Phone
+98 13 3355 3202
Fax
+98 13 3355 0097
Email
at_ghanbari@gums.ac.ir
Web page address
www.gums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)