Compare the effect of acupressure and aromatherapy on pain of knee in patients with multiple sclerosis (MS) referred to specific diseases center of Rafsanjan city in 2017
Comparison of the mean scores of pain in patients with multiple sclerosis in the aromatherapy group and acupressure group after intervention
Design
The study population consisted of patients with multiple sclerosis referred to Rafsanjan Special Disease Center. The sample size was estimated to be 30 individuals. Data collection tools included demographic information questionnaire , self-report form of pain characteristics. Samples were randomly divided into two groups, including aromatherapy and acupuncture. In the first group, lavender extract was administered 2% to the patients by fumigation machine. In the second group, acupressure was given to this group of necessary training and interventions
Settings and conduct
The study was performed at the Rafsanjan Special Disease Center. Samples were randomly assigned to acupuncture and aromatherapy. In the first group, 2% lavender extract was administered to patients by fumigation device. In the second group, acupressure group received necessary training and interventions. Visual Analogue Scale checklist was used before and after the intervention.
Participants/Inclusion and exclusion criteria
The criteria for entering the study include: 1- Having no swelling and numbness at the Hugo point 2. Having periodic examination records at the Rafsanjan Special Medical Center 3. Not having a history of using acupressure for any purpose
Exclusion criteria: 1. Reduced level of consciousness 2. The patient's unwillingness to continue cooperation
.
Intervention groups
Interventions were performed in two groups of acupressure and aromatherapy. Samples were assigned to two acupressure and aromatherapy groups by random sampling. In the first group, lavender extract of 2% was administered to the patients by inhalation apparatus. In the second group, acupressure was given to this group of training and interventions
Main outcome variables
knee pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181029041497N1
Registration date:2019-09-28, 1398/07/06
Registration timing:retrospective
Last update:2019-09-28, 1398/07/06
Update count:0
Registration date
2019-09-28, 1398/07/06
Registrant information
Name
Hossein Baghari nasab
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3429 1350
Email address
hosseinbaghari64@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-09-06, 1396/06/15
Expected recruitment end date
2018-03-02, 1396/12/11
Actual recruitment start date
2017-09-27, 1396/07/05
Actual recruitment end date
2018-03-04, 1396/12/13
Trial completion date
2018-12-17, 1397/09/26
Scientific title
Compare the effect of acupressure and aromatherapy on pain of knee in patients with multiple sclerosis (MS) referred to specific diseases center of Rafsanjan city in 2017
Public title
Compare the effect of acupressure and aromatherapy on pain of knee in patients with multiple sclerosis (MS)
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Not having the experience of using complementary medicine for any purpose
Having informed consent to participate in the study
Having a minimum score of 1 pain based on the scale of pain measurement
The lack of drug addiction
No injection of housing within 30 days before intervention
Having periodic examination records at the Rafsanjan Special Medical Center
Lack of olfactory disorder
Not having swollen and numbness at Hugo's point
Age range from 15 to 40 years
Exclusion criteria:
Changes in health status so that the patient can not continue to research
Loss of consciousness
Unwillingness to continue cooperation
Age
From 15 years old to 40 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
35
Actual sample size reached:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Since 30 patients were identified at Rafsanjan Special Disease Center, the samples were divided into two groups according to age and sex in two groups: acupuncture and aromatherapy.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee on Biomedical Research in Rafsanjan University of Medical Sciences
Street address
, No12 ,Kojeh No. 3 , Street hojat
City
rafsanjan
Province
Kerman
Postal code
7717795931
Approval date
2017-10-09, 1396/07/17
Ethics committee reference number
IR.RUMS.REC.1396.144
Health conditions studied
1
Description of health condition studied
Multiple sclerosis
ICD-10 code
G35
ICD-10 code description
Multiple sclerosis
Primary outcomes
1
Description
Measuring the amount of pain in the knee
Timepoint
Knee pain was measured three times before the intervention, immediately after intervention and one week after the intervention.
Method of measurement
Visual Analogue Scale
Secondary outcomes
1
Description
knee pain
Timepoint
Before intervention, after intervention and one week after intervention
Method of measurement
Pain measurement scale (vas)
Intervention groups
1
Description
Intervention group 1: Acupressure was performed in Hegu area for one minute and three consecutive nights before bedtime by a pre-trained patient.
Category
Treatment - Other
2
Description
Intervention group 2: 2 ml aromatherapy extract of aromatherapy extract, by night-time incubation until dawn, for 3 consecutive nights, pure lavender extract of Stoechas essential oil of Kashan Baridj Co. It was prepared.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Special Diseases Center of Rafsanjan
Full name of responsible person
Gollamhossein Abdeyazdan
Street address
No12. ,, Alley No. 3, Street hojat
City
rafsanjan
Province
Kerman
Postal code
7717795931
Phone
+98 34 3435 1136
Email
hosseinbaghari64@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Ali Shamsizadeh
Street address
No12 , Alley No. 3, Street Hojat
City
Rafsanjan
Province
Kerman
Postal code
7717795931
Phone
+98 34 3428 0086
Email
Hosseinbaghari64@Gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rafsanjan University of Medical Sciences
Proportion provided by this source
10
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
Islamic Azad University
Full name of responsible person
Gollamhossein Abdeyazdan
Position
MSc in medical_surgical nursing
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Community Health Research Center, Islamic Azad University, Isfahan Branch (Khorasgan), Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
7717795931
Phone
+98 31 3535 4059
Email
Gabdeyazdan@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Gollamhossein Abdeyazdan
Position
2- MSc in medical_surgical nursing
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Street j
City
Isfahan
Province
Kerman
Postal code
7717795931
Phone
+98 31 3535 4059
Email
Gabdeyazdan@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Gollamhossein Abdeyazdan
Position
Community Health Research Center, Islamic Azad University, Isfahan Branch (Khorasgan), Isfahan, Iran
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Community Health Research Center, Islamic Azad University, Isfahan Branch (Khorasgan), Isfahan, Iran
City
Isfahan
Province
Kerman
Postal code
7717795931
Phone
+98 31 3535 4059
Email
Gabdeyazdan@Yahoo.com
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
Yes - There is a plan to make this available
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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Sample data such as pain assessment score and demographic information form have been recorded
When the data will become available and for how long
Get started since 1397
To whom data/document is available
Researchers at Rafsanjan University of Medical Sciences
Under which criteria data/document could be used
The use of data is subject to authorization from the research department of Rafsanjan University of Medical Sciences
From where data/document is obtainable
Researchers Phone Number
What processes are involved for a request to access data/document
After obtaining a license from Lazmazsoo Vice-Chancellor for Research in Rafsanjan University of Medical Sciences and contacting researchers, this study provides enough information.