Purposes: prevention and control of nausea and vomiting is an important intervention in cancer patients. This study was performed with the aim of assessing the impact of ice massage on pericardium point (P6 or neiguan) by using ice mold on nausea and vomiting of cancer patients under chemotherapy. Methods and Materials: In a single blind randomized control clinical trial, 114 patients were studied by random allocation method in three groups of test, placebo and control. In the case group, the neiguan point of wrist was massaged slowly and gently by using the ice mold in the wet gauze that was placed by the patient or his accompany for 7 minutes twice a day with 12 hours interval. The placebo group was massaged in a same pattern by using wooden cube and the control group did not receive any action. Nausea and vomiting state were evaluated in three groups of samples by using the Morrow Assessment of Nausea and Emesis (MANE) questionnaire in 4 periods of time in 24 hours.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138804222046N1
Registration date:2009-07-13, 1388/04/22
Registration timing:prospective
Last update:
Update count:0
Registration date
2009-07-13, 1388/04/22
Registrant information
Name
Mehdi Sadeghi Shermeh
Name of organization / entity
Nursing Faculty, Baqiyatallah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2228 6057
Email address
m.sadeghi@bmsu.ac.ir
Recruitment status
Recruitment complete
Funding source
MSc Nursing student thesis
Expected recruitment start date
2009-07-23, 1388/05/01
Expected recruitment end date
2009-10-22, 1388/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of ice massage on nausea and vomiting of cancer patients under chemotherapy in the selective hospitals of Tehran
Public title
Effect of ice massage on nausea and vomiting of cancer patients under chemotherapy
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: 1. Chemotherapy drug regimens containing only Cisplatin and Etoposide received for the first time. 2. Using only Kytril for control of nausea and vomiting. 3. Lack of distraction and symptoms of psychotic history such as hallucinations and severe depression. 4. Absence of severe cardiac dysrhythmia. 5. Lack of uncontrolled hypertension. 6. Lack of respiratory discomforts. 7. Absence of brain metastasis and upper digestive system cancer and known metastasis. 8. Absence of electrolyte disorders 9. No consumption of drugs that cause drowsiness and disorientation. 10. Lack of musculoskeletal problems such as arthritis. 11. Lack of vascular problem in the neiguan point (with Allen test). 12. Only use chemotherapy method for cancer. 13. Absence of gastrointestinal or metabolic disease that will create nausea and vomiting (intestinal obstruction, gastritis, inflammation of oral mucosa, increased blood calcium, decreased blood sodium and uremia). 14. At least one of the patient's hands have no injury (ulcer or amputation) that prevent the implementation of ice massage or touch massage. 15. having more than 12 years old. 16. No visual impairment that prevents to see visual criteria of nausea severity measure. 17. The patient himself or his accompany is literate for filling the daily status report form. 18. BMI between 20 to 30. Exclusion criteria: 1. changing chemotherapy regime during the research. 2. Severe complications after chemotherapy and need to have care in the intensive care unit.
Age
From 12 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
114
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Baqiyatallah University of Medical Sciences
Street address
Mollah Sadra
City
Tehran
Postal code
1956837173
Approval date
2009-07-13, 1388/04/22
Ethics committee reference number
347
Health conditions studied
1
Description of health condition studied
Chemotherapy
ICD-10 code
Z51.1
ICD-10 code description
Chemotherapy session for neoplasm
2
Description of health condition studied
Cancer
ICD-10 code
C80
ICD-10 code description
Malignant neoplasm without specification of site
Primary outcomes
1
Description
Decrease of nausea and vomiting due to Chemotherapy
Timepoint
Every one hour
Method of measurement
Morrow Assessment of Nausea and Emesis ( MANE) Questionnaire
Secondary outcomes
1
Description
Decrease of Anti emetic drugs usage
Timepoint
24 hours
Method of measurement
By Checklist
Intervention groups
1
Description
Ice massage on pericardium 6 in case group
Category
Other
2
Description
Massage with wooden cube in Placebo group
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Tehran Emam Khomeini Hospital
Full name of responsible person
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Baqiyatallah University of Medical Sciences
Full name of responsible person
Abbas Ebadi
Street address
Aghdasieh
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Baqiyatallah 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
Baqiyatallah University of Medical Sciences, Nursing Faculty