Comparison of the effect of abdominal massage with and without Salvia officinalis aromatic substance on nausea, vomiting, and constipation of patients undergoing chemotherapy
Comparison of the effect of abdominal massage with and without Salvia officinalis aromatic substance on nausea, vomiting, and constipation of patients undergoing chemotherapy
Design
In this study samples will select by convenience sampling method .Then randomly will be allocated blocks into three groups;2 intervention groups (25 massage with salvia officinalis, 25 non-aromatic massage) and 25 in the control group .Nausea, vomiting and constipation in three groups will be measured before and after the study.
Settings and conduct
The abdominal Swedish way massage with or without scented salvia officinalis twice a day in oncology wards.
Participants/Inclusion and exclusion criteria
• Age over 18 years
• Constipation Assessment score of eight or higher
• Absence of coagulation disorder
• No history of migraine and chronic headache
• No history of allergy to herbs
• Lack of Meniere's syndrome
• Having no respiratory problems
• Insensitivity to aromatic substances
• no history of respiratory disease such as asthma, rhinitis, sinus disorders
• Do not use aromatherapy for patients within one week prior to the intervention
Intervention groups
For the control group, do not take any intervention.
In massage group without aromatic substances, only massage without abdominal matter will be used.
In group with aromatic matter; abdominal massage withsalvia officinalis will be used. How to do an intervention in a massage group with a scented substance is exactly the same as a massaging group without aromatic matter, with the difference that in this method of use the aromatic herbal syrup of 2 cc (making barij Kashan essential oil) at each massage time for abdominal massage will be.
Main outcome variables
Nausea, vomiting and constipation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20141109019862N7
Registration date:2019-04-20, 1398/01/31
Registration timing:prospective
Last update:2019-04-20, 1398/01/31
Update count:0
Registration date
2019-04-20, 1398/01/31
Registrant information
Name
Sakine Sabzevari
Name of organization / entity
Kerman University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 34 3132 5219
Email address
s_sabzevari@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-04-21, 1398/02/01
Expected recruitment end date
2019-10-23, 1398/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of abdominal massage with and without Salvia officinalis aromatic substance on nausea, vomiting, and constipation of patients undergoing chemotherapy
Public title
Comparison of the effect of abdominal massage with and without Salvia officinalis aromatic substance on nausea, vomiting, and constipation of patients undergoing chemotherapy
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 18 years
Constipation Assessment Score of eight or higher
Exclusion criteria:
Coagulation disorders
History of migraine and chronic headache
History of allergy to herbs
Meniere's syndrome
Respiratory problems
Sensitivity to aromatic substances
History of respiratory disease such as asthma, rhinitis, sinus disorders
Use aromatherapy for patients one week before intervention
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
75
Randomization (investigator's opinion)
Randomized
Randomization description
Samples (75 people) will select by convenience sampling method .Then randomly will be allocated blocks into three groups;2 intervention groups (25 massage with salvia officinalis , 25 non-aromatic massage) and 25 in the control group. In this method, random block allocation will perform by the software.
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
Ethical committee of Kerman University of Medical Sciences
Street address
Jahad Blvd, Ebn Sina avenue
City
kerman
Province
Kerman
Postal code
76177
Approval date
2019-02-18, 1397/11/29
Ethics committee reference number
IR.KMU.REC.1397.464
Health conditions studied
1
Description of health condition studied
neoplasm
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Nausea, vomiting and constipation
Timepoint
Before intervention, immediately after abdominal massage, and a week after abdominal massage.
Method of measurement
The instrument will be a questionnaire consisting of three parts; demographic information, Constipation Assessment Scale and Visual Analog Scale for nausea and vomiting.
Secondary outcomes
empty
Intervention groups
1
Description
Control group: In this group for the control of nausea, vomiting and constipation are the drugs prescribed by the doctor digestive and laxative use and there is no intervention.
Category
N/A
2
Description
Intervention group: In this group, in addition to routine care only of abdominal massage without aromatic material will be used. Before the massage, patient privacy is maintained. How do massage is the massage for half an hour on an empty stomach before feeding is done for patient comfort. The patient is placed in the back rest so that the legs bend from the knees slightly and the head is at a angle of 15 to 30 degrees. Coverage of the massage area is removed from the upper anterior lobe of the iliac buccal underneath the lower chest ribs and the rest of the body is covered. Then the massage therapist, who is a member of the patient family, is on the right and facing the lower level of the patient's pelvis. Massage begins. It should be noted that accompanying the patient after examination of the patient's stomach in terms of mass and other prohibitions of massage, in the absence of a problem, massage begins. Massage in a clockwise direction and start from scratch ascending colon, the colon and the descending colon landscape and finally to the end of the massage continues. Massage in Swedish massage style involves stroking or stroking, eyelinating, or gyrotic, vibration or vibration and hand massage or nidding 2 times a day for 15 minutes at 8:30 and 20:30. Massage time is set to take place at fixed intervals and not interfere with the patient's sleep.
Category
Other
3
Description
2 Intervention group: In this group, in addition to routine care abdominal massage with salvia officinalis will be used. How to do an intervention in a massage group with a scented substance is exactly the same as a massaging group without aromatic matter, with the difference that in this method of use 2 cc the salvia officinalis (making barij Kashan essential oil) at each massage time for abdominal massage will be.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
All centers of oncology (Beysat Specialist Clinic, Samen Alaeman Clinic, Jawat Alaem Specialist Clin
Full name of responsible person
Dr Sakineh Sabzevari
Street address
Haft Bagh Blvd
City
Kerman
Province
Kerman
Postal code
76177
Phone
+98 34 3132 5219
Fax
+98 34 3132 5418
Email
S_Sabzevari@kmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Dr Sakineh Sabzevari
Street address
Haft Bagh highway,Kerman Medical University Campus
City
Kerman
Province
Kerman
Postal code
76177
Phone
+98 34 3132 5219
Fax
+98 34 3132 5218
Email
S_Sabzevari@kmu.ac.ir
Grant name
No Funding
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman University of Medical Sciences
Proportion provided by this source
1
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Dr Sakineh Sabzevari
Position
Associate Professor, Faculty Member
Latest degree
Ph.D.
Other areas of specialty/work
Medical Education
Street address
Haft Bagh Blvd
City
Kerman
Province
Kerman
Postal code
76177
Phone
+98 34 3132 5219
Fax
+98 34 3132 5218
Email
S_Sabzevari@kmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Dr Sakineh sabzevari
Position
Associate Professor, Faculty Member
Latest degree
Ph.D.
Other areas of specialty/work
Medical Education
Street address
Haft Bagh Blvd
City
Kerman
Province
Kerman
Postal code
76177
Phone
+98 34 3132 5219
Fax
+98 34 3132 5218
Email
S_Sabzevari@kmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Dr Sakineh Sabzevari
Position
Associate Professor, Faculty Member
Latest degree
Ph.D.
Other areas of specialty/work
Medical Education
Street address
Haft Bagh Blvd
City
Kerman
Province
Kerman
Postal code
76177
Phone
+98 34 3132 5219
Fax
+98 34 3132 5218
Email
S_Sabzevari@kmu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
As an original article
When the data will become available and for how long
After publish as an article in a journal
To whom data/document is available
Public
Under which criteria data/document could be used
For undergoing chemotherapy patients and research fields
From where data/document is obtainable
Published documents
What processes are involved for a request to access data/document