This is a randomized clinical trial study to investigate the effect of Jasmine aromatherapy with or without massage therapy on severity of the common signs in cancer patients undergoing chemotherapy. Study will be conducted in Amir Hospital of Shiraz and from November 2015 to January 2016. Seventy five patients who have been received chemotherapy will be divided randomly in three groups of aromatherapy (group 1), massage therapy (group 2) and aroma massage therapy (group 3). Each group contains twenty five patients. All subjects will be received interventions twice a week for four weeks; on average each 2.5 days. In a group 1 aroma of Jasmine will be distributed in a room by humidifier and inhaled for one hour, while diluted oil will be rubbed on a site of pain and remained in this time, In a group 2 about 20 minutes Swedish massage (effleurage) with almond oil will be applied and in a group 3 Jasmine oil used as a lubricant for massage. Tools for assessing variables of this study are: FACT-GOG questionnaire for neuropathy, MASCC Anti Emetic Tool for nausea and vomiting, Brief Pain Inventory for pain and Schwartˈs Fatigue Scale for fatigue.Patients will complete questionnaires in accordance with their structure: -nausea and vomiting, fatigue, pain: 1 hour before each intervention, 24 hour and 48 hour after each intervention; - neuropathy: 1 hour before and 7 days after each intervention
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015102824757N1
Registration date:2015-11-12, 1394/08/21
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-11-12, 1394/08/21
Registrant information
Name
Marziyeh Mohebbi
Name of organization / entity
Yasuj University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 74 3323 5141
Email address
marziyeh.mohebi@yums.ac.ir
Recruitment status
Recruitment complete
Funding source
Research Council of Yasuj University of Medical sciences
Expected recruitment start date
2015-11-11, 1394/08/20
Expected recruitment end date
2016-01-10, 1394/10/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Jasmine aromatherapy with or without massage therapy on severity of the common signs in cancer patients undergoing chemotherapy
Public title
Comparison of aroma massage therapy in cancer patients
Purpose
Supportive
Inclusion/Exclusion criteria
inclusion criteria: who had been received chemotherapy include Oxaliplatine or Cisplatine; have experienced at least minimum symptoms of neuropathic pain and nausea and vomiting and pain and fatigue; filled in patient's consent; aged above 16 years; Platelet above 50000; WBC more than 2500; positive olfactory test; negative sensitivity test and Exclusion criteria are: disorientation to time and place and person; known mental disorder; DVT; coagulation disorder; skin problem; bone fraction and extensive bruise
Age
From 16 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
75
Randomization (investigator's opinion)
N/A
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
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
00987591741417
Approval date
2015-10-20, 1394/07/28
Ethics committee reference number
yums.REC.1394.90
Health conditions studied
1
Description of health condition studied
neoplasms
ICD-10 code
C00, C01,
ICD-10 code description
Malignant neoplasms
Primary outcomes
1
Description
nausea and vomiting
Timepoint
1hour before,24 hours and 2 days after intervention
Method of measurement
MASCC Anti Emetic Tool
2
Description
Fatigue
Timepoint
1 hour before each intervention, 24 hour and 48 hour after each intervention
Method of measurement
Schwartˈs Fatigue Scale
3
Description
pain
Timepoint
1 hour before each intervention, 24 hour and 48 hour after each intervention
Method of measurement
Brief Pain Inventory
4
Description
neuropathy
Timepoint
1 hour before and 7 days after each intervention
Method of measurement
FACT-GOG questionnaire for neuropathy
Secondary outcomes
empty
Intervention groups
1
Description
group 1 or aromatherapy: meanwhile the aroma of Jasmine will be distributed in a room by humidifier and inhaled for one hour, diluted oil will be rubbed on a site of pain and remained in this time.
Category
N/A
2
Description
In a group 2 or massage therapy: about 20 minutes Swedish massage (effleurage) with almond oil will be applied
Category
N/A
3
Description
In a group 3 or massage aromatherapy: about 20 minutes Swedish massage (effleurage) with Jasmine oill will be applied
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Amir Hospital of Shiraz
Full name of responsible person
Doctor Mehdi Akbartabar turi
Street address
Research Management of Yasuj University of Medical Sciences, Research and Technology Deputy of Yasuj University of Medical Science, Shahid Motahary Blvd., Yasuj
City
Yasuj
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yasuj University of Medical sciences
Full name of responsible person
Doctor Mehdi Akbartabar turi
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
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yasuj 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
Yasuj University of Medical Sciences
Full name of responsible person
Dr. Ardashir Afrasiabifar
Position
Ph.D of Medical Surgical Nursing- Associate Professor
Other areas of specialty/work
Street address
Nursing and Midwifery College, Shahid Dr. Jalil St., Yasuj
City
Yasuj
Postal code
Phone
+98 74 3323 5141
Fax
+98 74 3334 6079
Email
afrasiabifar@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yasuj University of Medical Sciences
Full name of responsible person
Dr. Ardashir Afrasiabifar
Position
Ph.D of Medical Surgical Nursing- Associate Professor
Other areas of specialty/work
Street address
Nursing and Midwifery College, Shahid Dr. Jalil St., Yasuj
City
Yasuj
Postal code
Phone
+98 74 3334 6078
Fax
+98 74 3334 6079
Email
afrasiabifar@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Yasuj University of Medical Sciences
Full name of responsible person
Marziyeh Mohebbi
Position
MS student of Medical Surgical Nursing
Other areas of specialty/work
Street address
Nursing and Midwifery College, Shahid Dr. Jalil St., Yasuj