The objective of this study is determination the effect of Auricular acupressure on nausea and vomiting in patients undergoing chemotherapy. This study is a cross over clinical trial. The study population included 48 patients who referred to Rassoul Akram hospital and Institute cancer. The eligibility criteria included patients Aged 18-65 years, who will be under the first time chemotherapy with cisplatin and anthracycline. Patients who have the history of acupressure during 3 months ago or take anti-emetic drugs, individuals who are reluctant to complete the study will be excluded. After obtaining inform consent, stratified randomized block design sampling method will be used to recruit the study subjects. The control group will receive usual treatment of nausea and vomiting like anti-emetic drugs, but in the intervention group, an auricular acupressure contains specific plant seeds will be applied to their ears besides the routine treatment. The pressure will be applied to the certain points like Shen Men by researcher. As the seeds remains on the ear for 5 days, patients will be trained to press this point three times a day for 3 minute each time (morning, noon and night). To assess the nausea and vomiting, Morrow questionnaire will be completed for the subsequent 5 days by both the intervention and the control group. After an interval 3 weeks, in the second line of chemotherapy a cross-over was performed. The questionnaire will be completed again, then the first and second phase data will be compared.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013120415649N1
Registration date:2014-06-14, 1393/03/24
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-06-14, 1393/03/24
Registrant information
Name
Mohammad Eghbali
Name of organization / entity
Torbat Heydariyeh University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 5242 1257
Email address
m-eghbali@alumnus.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Tehran University of Medical Science
Expected recruitment start date
2014-02-09, 1392/11/20
Expected recruitment end date
2014-06-21, 1393/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison The Effect of Auricular Acupressure and routine drug on chemotherapy induced Nausea and Vomiting in cancer patients
Public title
The effect of Auricular acupressure on nausea and vomiting induced by chemotherapy
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria: patients Aged 18-65 years, who will be under the first time chemotherapy with cisplatin and anthracycline, have a normal ear or no injury, Patients who have the history of acupressure during 3 months ago or take anti-emetic drugs, individuals who are reluctant to complete the study will be excluded.
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
48
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Science
Street address
Sixth Floor, Central Organization of University, Qods St, Keshavarz Blvd
City
Tehran
Postal code
Approval date
2014-02-17, 1392/11/28
Ethics committee reference number
2709/130/د/92
Health conditions studied
1
Description of health condition studied
Chemotherapy Induce Nausea and Vomiting
ICD-10 code
R11
ICD-10 code description
Nausea and vomiting
Primary outcomes
1
Description
Acute and delayed nausea
Timepoint
ِData are gathered for five days after starting chemotherapy
Method of measurement
Morrow questionnaire
Secondary outcomes
1
Description
Acute and delayed vomiting
Timepoint
Data are gathered for five days after starting chemotherapy
Method of measurement
Morrow questionnaire
Intervention groups
1
Description
In the control group, standard antiemetics prescribed by a physician only will be use.
Category
Other
2
Description
In the intervention group, an auricular acupressure contains specific plant seeds will be applied to their ears besides the routine treatment. The pressure will be applied to the certain points like Shen Men by researcher. As the seeds remains on the ear for 5 days, patients will be trained to press this point three times a day for 3 minute each time (morning, noon and night).
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Cancer Institute of Imam Khomeini Hospital in Tehran
Full name of responsible person
Mohammad Eghbali
Street address
Cancer Institute Central 2, Dr. Gharib St.
City
Tehran
2
Recruitment center
Name of recruitment center
Rasoul akram hospital
Full name of responsible person
Mohammad Eghbali
Street address
Niayesh St, sattarkhan St.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Tehran University of Medical Sciences
Full name of responsible person
Doctor Masood Younesian - Vice President of Research and Technology
Street address
Keshavarz St, Qods St., Central Building, Sixth Floor, Tehran University of Medical Sciences, Tehran
City
Tehran
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, Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Mohamad Eghbali
Position
Nursing Graduate Student
Other areas of specialty/work
Street address
School of Nursing and Midwifery Tehran University of Medical Sciences, Dr Mirkhani St, Tohid Sq Tehran
City
Tehran
Postal code
Phone
+98 21 6692 7171
Fax
Email
eghbali.msn@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Doctor Shokouh Varaei
Position
PhD in Nursing
Other areas of specialty/work
Street address
School of Nursing and Midwifery Tehran University of Medical Sciences, Dr Mirkhani St, Tohid Sq Tehran
City
Tehran
Postal code
Phone
+98 21 6693 7120
Fax
Email
Shvaraei@sina.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Eghbali
Position
Nursing Graduate Student
Other areas of specialty/work
Street address
School of Nursing and Midwifery Tehran University of Medical Sciences, Dr Mirkhani St, Tohid Sq, Tehran
City
Tehran
Postal code
Phone
+98 21 6693 7120
Fax
+98 53 3722 9878
Email
eghbali.msn@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)