This study aimed to evaluate the effect of ice massage and C-band methods on acute and delayed chemotherapy-induced nausea and vomiting in patients with cancer. Inclusion criteria for the study: experiencing at least one episode of nausea and vomiting (from moderate to severe) caused by chemotherapy; adult patients admitted to the hospital for chemotherapy; and the ability to communicate. Exclusion criteria: any critical conditions of the patient; unwillingness to continue the collaboration; mental disorders; disease or malignancy leading to nausea and vomiting; taking drugs or drinking alcohol; and any harm in neiguan point. Study population: patients undergoing chemotherapy who came to the Shahid Rajai Hospital of Yasouj, Kohgiluyeh and Boyer-Ahmad, Iran. Sample size: 105 patients were randomly divided into three groups, including intervention with ice massage (Group 1), the C-band (group 2), and the control group (Group 3). Intervention: contained three groups including Group 1: ice massage on the neiguan spot, slowly for seven minutes and twice a day for 6 days (every 12 hours); Group 2: elastic bands were closed for 6 days on neiguan point in the wrist; and Group 3: the control group. Data was collected before, 6, 12, 18 and 24 hours after the intervention and more than 2 days after the intervention. Primary outcomes: acute and delayed nausea and vomiting in cancer patients undergoing chemotherapy.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016041927467N1
Registration date:2016-08-20, 1395/05/30
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-08-20, 1395/05/30
Registrant information
Name
Masoumeh Mohamadian
Name of organization / entity
Yasuj University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 74 3233 0997
Email address
mohamadian.masoumeh@yums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Yasuj University of Medical Sciences
Expected recruitment start date
2016-05-28, 1395/03/08
Expected recruitment end date
2016-08-20, 1395/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of ice massage and C-band on acute and delayed chemotherapy-induced nausea and vomiting in cancer patients
Public title
Comparison of the effect of acupressure on nausea and vomiting caused by chemotherapy
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:At least one course of chemotherapy which can cause moderate to severe nausea and vomiting are gone, at least once nausea caused by chemotherapy have experienced any severity, hospitalization for chemotherapy, the ability to communicate, age over 12 years, avoiding the use of drugs that confusion and lack of awareness of time and place.Exclusion criteria: the deterioration of the patient in a way that is not able to continue to participate in research, not wanting to continue to participate in the study, psychiatric disorders, gastrointestinal tract and brain cancer, electrolyte imbalances, metabolic disorders, leading to nausea and vomiting. , taking drugs and alcohol, inner ear disorders, there are issues such as inflammation, sores, swelling, fractures, burns, skin lesions and vascular problems in the neiguan (pericardium 6)
.
Age
From 12 years old to 90 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
0
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
One hundred and five patients with cancer undergoing chemotherapy in a randomized block design will be divided into three groups And being blind to a patient of intervention (that what belongs to the group of study) is not informed.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Yasuj University of Medical Sciences
Street address
Research Management of Yasuj University of Medical Sciences, Research and Technology Deputy of Yasuj University of Medical Sciences, Shahid Motahary Blvd., Yasuj, Iran
City
yasuj
Postal code
7591994799
Approval date
2016-05-28, 1395/03/08
Ethics committee reference number
Code of ethics:IR.YUMS.REC.1395.45
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
Before the intervention, 6, 12, 18 and 24 hours after intervention from the 2 days after intervention
Method of measurement
Morrow questionnaire
Secondary outcomes
1
Description
Acute and delayed vomiting
Timepoint
Before the intervention, 6, 12, 18 and 24 hours after intervention from the 2 days after intervention
Method of measurement
Mask questionnaire
Intervention groups
1
Description
Ice massage on pericardium 6 in case group۱
Category
Other
2
Description
In the second study group Elastic band has buttons for 6 days on neiguan point in the wrist, will be closed.
Category
Other
3
Description
In the control group, standard antiemetics prescribed by a physician only will be use