Objective: To determine the effect of reflexology on reducing vomiting in patients undergoing chemotherapy Oncology - Hematology Hospital Ali Ibn Abi Talib (AS) University in 1388
Design of study: This study was a quasi-experimental study before and after the clinical trial or the pre-test was conducted with a group
Main inclusion criteria: at least one course of chemotherapy and undergone chemotherapy with drugs or treatment of moderate to severe can cause vomiting.Side effects of acute vomiting that has occurred. - Other treatments such as radiation therapy during the study, it is not in the program. - A-day drug regimen should be treated. The main criteria for exclusion from the study: Examples disease such as fever, leukemia, epilepsy, cellulitis and infection, deep vein thrombosis and psychosis and gastric cancer, thrombosis and was paralyzed. (Banned because of the reflections). Examples of disorders and difficulties in the leg were any intervention for them was painful sample size: 35 intervention or interventions studied: massage point feet to reduce vomiting during the intervention: 20 minutes (10 minutes for each leg) outcome or outcomes of the study: the impact of foot massage on reducing vomiting for 4-6 hours.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138903163417N2
Registration date:2012-08-27, 1391/06/06
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-08-27, 1391/06/06
Registrant information
Name
Nazanin Yoosefian Miandoab
Name of organization / entity
Zahedan University of Medical Sciences - School of Nursing and Midwifery
Country
Iran (Islamic Republic of)
Phone
+98 54 1242 9089
Email address
j_ezati@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Reasercher
Expected recruitment start date
2009-09-23, 1388/07/01
Expected recruitment end date
2010-02-19, 1388/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Reflexology impact on reducing vomiting in patients undergoing chemotherapy Oncology - Hematology Hospital Ali Ibn Abi Talib (AS) University in 1388
Public title
Reflexology impact on reducing vomiting in patients undergoing chemotherapy
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
.1 - be alert. (Awareness of time and place and person) 2 - have over 18 years of age 3 - spent at least one course of chemotherapy and chemotherapy with drugs or treatment of moderate to severe can cause vomiting.4 - Side effects of acute vomiting that has occurred. 5 - other treatments such as radiation therapy during the study, it is not in the program. 6 - a-day drug regimen should be treated.
Exclusion criteria
1- were examples of women during pregnancy and menstruation. 2 - Examples disease such as fever, leukemia, epilepsy, cellulitis and infection, deep vein thrombosis and psychosis and gastric cancer, thrombosis and was paralyzed. (Banned because of the reflections) 3 - Examples of problems in the leg were impaired and if the intervention was painful for them.
Age
To 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
35
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
International Branch martyr Beheshti University of Medical Sciences and Health Services
Street address
Street, Vali-Asr Avenue - martyr Abbaspour (Tavanir) - St. Paul Hammett - No. 19
City
Tehran
Postal code
Approval date
2009-09-20, 1388/06/29
Ethics committee reference number
676/116
2
Ethics committee
Name of ethics committee
Zahedan University of Medical Sciences
Street address
Persian Gulf Boulevard - Medical Sciences Campus - Research
City
Zahedan
Postal code
Approval date
2010-01-05, 1388/10/15
Ethics committee reference number
88-2467
Health conditions studied
1
Description of health condition studied
Vomiting caused by chemotherapy
ICD-10 code
R11
ICD-10 code description
Nausea and vomiting
Primary outcomes
1
Description
Reduce the number of acute vomiting in patients undergoing chemotherapy treatment method using Reflection
Timepoint
(first 4 hours -second 4 hours - third 4 hours) first 12 hours and second 12 hours after the intervention
Method of measurement
Questionnaire vomiting (a combination of questionnaires and the Moro National Cancer Institute Toxicity Criteria version 2 manual America)
2
Description
Reduce the severity of acute vomiting in patients undergoing chemotherapy treatment method using Reflection
Timepoint
(first 4 hours -second 4 hours - third 4 hours) first 12 hours and second 12 hours after the interventionr the second
Method of measurement
Questionnaire vomiting (a combination of questionnaires and the Moro National Cancer Institute Toxicity Criteria version 2 manual America)
Secondary outcomes
empty
Intervention groups
1
Description
Control group in this study received anti-vomiting and Granisetron efficacious half-life 12-9 hours, which coincided with the start of chemotherapy were administered 3 mg and the doctor ordered.Granisetron injections per patient since the beginning of chemotherapy and 24 hours (if admitted in part, by the researcher as a personAnd in case of discharge, a telephone by the researcher) was studied.So the second part of the questionnaire survey vomiting In four separate times by the end of 24 hours were completed.(4 hours, 4 hours, second, third, 4 hours, 12 second).
Category
Treatment - Drugs
2
Description
Samples in the next month (with a distance of 15 to 20 days before the visit) were in the intervention group. Before, the patient explained that in addition to all therapeutic measures that will be done as before, the pressure point for his feet will be and also to ensure patients were in case of vomiting, the drug was injected again. Simultaneously with the start of chemotherapy, drug Granisetron was used but in the case of severe and distressing vomiting or vomiting for 24 hours was more than 5 times; in case of hospitalized patients and vomiting in the drug Granisetron was used and the patient was in attendance and was controlled by telephone from IV metoclopramide was used). Intervention for this group was to put pressure on the solar system. Reflection points for this area, both feet on the floor, just below the center of the foot, connecting the midpoint of the second and third metatarsal bones and in case the patient flat on his back lying down or sitting by fines thumb, press firmly on the area to the pain by the patient at the same point be expressed, were applied in this work from the other fingers and hands other support was used. The first operation was performed on the right foot then left foot (10 minutes for each leg). After the massage, the patient started chemotherapy and reflexology performed by researchers at four separate time from the questionnaires were completed by the second part (4 hours, 4 hours, second, third, 4 hours, 12 second).
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Ali Ibn Abi Talib Hospital in Zahedan
Full name of responsible person
Street address
City
Zahedan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research Assistance Shahid Beheshti Nursing and Midwifery University
Full name of responsible person
Farideh Yaghmayi
Street address
Tehran - Shariati St - end Mirdamad Alley - Gift - Graduate School of Nursing and Midwifery martyr Beheshti
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Assistance Shahid Beheshti Nursing and Midwifery University
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
University School of Nursing
Full name of responsible person
Nazanin Yousefian Miandoab
Position
Master of Nursing
Other areas of specialty/work
Street address
Zahedan - Blvarbhdasht - Circle of Mashahir- University School of Nursing
City
Zahedan
Postal code
Phone
+98 54 1322 6386
Fax
Email
n.yoosefian@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti Nursing and Midwifery University
Full name of responsible person
Ezzati Jaleh
Position
MS in Nursing
Other areas of specialty/work
Street address
Tehran - Shariati St - end Mirdamad Alley - Gift - Graduate School of Nursing and Midwifery martyr Beheshti
City
Tehran
Postal code
Phone
+98 22229648
Fax
Email
j_ezati@sbmu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti Nursing and Midwifery University
Full name of responsible person
Ezzati Jaleh
Position
MS in Nursing
Other areas of specialty/work
Street address
Tehran - Shariati St - end Mirdamad Alley - Gift - Graduate School of Nursing and Midwifery martyr Beheshti
City
Tehran
Postal code
Phone
+98 212229648
Fax
Email
j_ezati@sbmu.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)