The purpose of this randomized clinical trial is to compare the effects of electrical stimulation (TENS) and acupressure on nausea and vomiting induced by chemotherapy.
Design
In this research, 120 eligible patients undergoing chemotherapy will be randomly recruited into one of 4 groups: intervention 1 and 2, and controls 1 and 2. The method of randomization is based on the sealed envelope. All patients are unaware of the exposure. In this study, the patient is identified with a code in the envelope, and it is determined elsewhere that this is an intervention number or a placebo. The phase of the clinical trial is not applicable in this study.
Settings and conduct
The purpose of this randomized clinical trial is to compare the effects of electrical stimulation of skin (TENS) and acupressure on nausea and vomiting induced by chemotherapy.
Participants/Inclusion and exclusion criteria
The study population is all cancer patients over 18 years of age who are referred to Cancer Research Department of Kowsar Hospital. The main inclusion criteria are the history of receiving at least one chemotherapy course and a history of nausea experience following previous chemotherapy sessions. The main exclusion criteria are receiving radiotherapy (total or upper abdominal) simultaneously with chemotherapy and the use of drugs or other therapies to reduce nausea.
Intervention groups
Intervention group 1: receiving TENS electric stimulation for 30 minutes at 10 Hz and a 500 msec pulse duration, with a tolerable intensity, to the P6 point of the wrist, once daily, on both hands for 5 consecutive days.
Intervention group 2: Acupuncture wrist band on the P6 point of the wrist, permanently, on both hands for 5 consecutive days.
Control group 1: receiving placebo TENS electric stimulation for 30 minutes to the P6 point of the wrist, once daily, on both hands for 5 consecutive days.
Control group 2: ordinary wrist band on the P6 point of the wrist, permanently, on both hands for 5 consecutive days.
Main outcome variables
nausea and vomiting
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20100618004203N14
Registration date:2018-01-02, 1396/10/12
Registration timing:registered_while_recruiting
Last update:2018-01-02, 1396/10/12
Update count:0
Registration date
2018-01-02, 1396/10/12
Registrant information
Name
Atefeh Aminian Far
Name of organization / entity
Semnan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 23 1335 4180
Email address
aminianfar@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor for research, Semnan University of Medical Sciences
Expected recruitment start date
2017-12-21, 1396/09/30
Expected recruitment end date
2018-05-05, 1397/02/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative study of transcutaneous electrical nerve stimulation (TENS) and acupressure on chemotherapy-induced nausea and vomiting.
Public title
Tanscutaneous electrical nerve stimulation (TENS), acupressure and chemotherapy-induced nausea and vomiting.
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 18
Use of nauseous diets such as cisplatin alone or in combination with other chemotherapeutic agents with the same amount and administration in two cycles of chemotherapy without planning for radiotherapy in cycles
At least four times chemotherapy
Exclusion criteria:
Having a history of nausea and vomiting for reasons other than chemotherapy;;
Taking anti-epithelial (emend) medication
Treatment with corticosteroid medications during the cycles
Using pacemakers
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization tool: Sealed envelope
Blinding (investigator's opinion)
Single blinded
Blinding description
Patients do not understand which of the two control or test groups belong. All patients are unaware of the exposure. In this study, the patient is identified with a code in the envelope, and it is determined elsewhere that this is an intervention number or a placebo.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Semnan University of Medical Sciences
Street address
Bassij Blvd, Semnan University of Medical Sciences, Semnan, Iran.
City
Semnan
Province
Semnan
Postal code
3519899951
Approval date
2017-10-19, 1396/07/27
Ethics committee reference number
ir.semums.rec.1396.110
Health conditions studied
1
Description of health condition studied
Cancer
ICD-10 code
C00-C75
ICD-10 code description
Malignant neoplasms, stated or presumed to be primary, of specified sites, except of lymphoid, haematopoietic and related tissue
Primary outcomes
1
Description
nausea and vomiting
Timepoint
In hours 1,2,3 and 4 after intervention and 24 hours after beginning of chemotherapy and 5 days later.
Method of measurement
checklist and cortilla tool
Secondary outcomes
empty
Intervention groups
1
Description
In the intervention group 1: receiving TENS electric stimulation for 30 minutes at 10 Hz and a 500 msec pulse duration, with a tolerable intensity, to the P6 point of the wrist, once daily, on both hands for 5 consecutive days.
Category
Prevention
2
Description
In the intervention group 2: Acupuncture wrist band on the P6 point of the wrist, permanently, on both hands for 5 consecutive days.
Category
Prevention
3
Description
In the control group 1: receiving placebo TENS electric stimulation for 30 minutes to the P6 point of the wrist, once daily, on both hands for 5 consecutive days.
Category
Prevention
4
Description
In the control group 2: ordinary wrist band on the P6 point of the wrist, permanently, on both hands for 5 consecutive days.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Kosar hospital of Semnan
Full name of responsible person
Dr Atefeh Aminian Far
Street address
Basij Blvd
City
Semnan
Province
Semnan
Postal code
3519899951
Phone
+98 23 3142 2001
Email
atf.amin@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Dr, Ali Rashidipour
Street address
Bassij Blvd, Deputy of Research, Semnan University of Medical Sciences, Semnan, Iran
City
Semnan
Province
Semnan
Postal code
3519899951
Phone
+98 23 3344 0225
Email
aminfar83@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan 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
Semnan University of Medical Sciences
Full name of responsible person
Dr. Atefeh Aminian Far
Position
Ph.D of Physiotherapy/ Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Kilometer 5 Damghan road, Semnan University of Medical Sciences
City
Semnan
Province
Semnan
Postal code
3519899951
Phone
+98 23 3365 4180
Fax
Email
aminfar@semums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Dr. Atefeh Aminian Far
Position
Ph.D of Physiotherapy/ Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Kilometer 5 Damghan road, Semnan University of Medical Sciences
City
Semnan
Province
Semnan
Postal code
3519899951
Phone
+98 23 3365 4180
Fax
Email
aminfar@semums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Dr. Atefeh Aminian Far
Position
Ph.D of Physiotherapy/ Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Kilometer 5 Damghan road, Semnan University of Medical Sciences
City
Semnan
Province
Semnan
Postal code
3519899951
Phone
+98 23 3365 4180
Fax
Email
aminfar@semums.ac.ir
Web page address
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
No - There is not a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
No - There is not 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