Effect of Aromatherapy with Citrus aurantium Essential Oil On Anxiety during Magnetic Resonance Imaging in Spinal disorder Imam Khomeini Hospital Saghez,2018
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Secondary Ids
#1
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2018-02-01, 1396/11/12
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2018-02-01 00:00:00
Ethics committees
#1
IR.IUMS.REC.1394.26598
IR.MUK.REC.1396.329
IR.IUMS.REC.1394.26598IR.MUK.REC.1396.329
Protocol summary
Study aim
Effect of Flavor Scent on Anxiety During Imaging of Magnetic Fields in Patients with Spinal disorder Referring to Imam Khomeini Hospital in Saqez City in 1396
Design
This study is a clinical trial " after only design intervention" with random allocation in two groups of control and intervention that will be performed on 60 patients who are referred to Imam Khomeini Hospital in Saqez for magnetic field imaging. In this study, Two groups of intervention and control are performed on a weekly basis, one week per week. Choosing which first group is to be drawn in random order. After that, the sampling will be carried out in a simple random manner. For this purpose The sampling frame contains the names of all patients who have been switched to the single-shot imaging schedule Dan is magnetic. After the numbering of the patients' names, a random number table is used for sampling. The patients' anxiety level was measured by the Spiel questionnaire and patients with a mild to moderate anxiety level were enrolled in the study.
Settings and conduct
Intervention in this study is an essential oil essential oil that is purchased from a prestigious university unit. After determining the concentration by weight measurement, this essential oil is 10 mg of essential oil in 100 ml of the product. Before intervention, anxiety scales MRI-AQ is not evaluated by any group. In the intervention group, three drops of essential oil are sprayed onto cotton swabs and patients are asked to smell it for 5 minutes at a distance of 10 cm and then after entering the Magnetic field imaging room A gas dipped into three drops of orange spring essential oil by the researcher A collaborator will be attached to the patient's collar with a plastic clamp and immediately after the magnetic field is evaluated, the MRI-AQ anxiety score is evaluated. In the control group, they receive only the usual care of the treatment center. This process completes the necessary samples for further research. Finds. Heart rate and blood pressure and nausea, vomiting and headache are controlled by the aromatherapy.
Participants/Inclusion and exclusion criteria
Patients aged 65-18 years old, lack of specific illness (allergy, olfactory disorder, anxiety disorder), lack of psychotropic drugs, lack of respiratory problems, non-performing magnetic resonance imaging, outpatients, patients with spinal disorders (neck and waist) ) And spinal column abnormalities (skeletal, kyphosis, lordosis), mild to moderate anxiety in both control and intervention groups. Entry into study
Any medical or surgical problem requiring urgent medical intervention during the study, nausea and vomiting, and sensation of subtle scent, discontent after each inhalation, discontinuation of the research unit and reluctance to continue participating in the study for any reason, having severe anxiety , General anxiety disorder, compulsive obsessive-compulsive disorder, closed-air fear and social fear Exclusion criteria
Intervention groups
A group of 10% Orange Spring scents for 10 minutes before scanning magnetic field imaging and scanning.
The control group only receives standard care from the health center
Main outcome variables
Anxiety
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180117038414N1
Registration date:2018-02-13, 1396/11/24
Registration timing:prospective
Last update:2018-05-20, 1397/02/30
Update count:1
Registration date
2018-02-13, 1396/11/24
Registrant information
Name
Nishtman Ahani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 87 3622 6409
Email address
n.ahani63@muk.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-02-20, 1396/12/01
Expected recruitment end date
2018-05-22, 1397/03/01
Actual recruitment start date
2018-02-20, 1396/12/01
Actual recruitment end date
2018-05-22, 1397/03/01
Trial completion date
empty
Scientific title
Effect of Aromatherapy with Citrus aurantium Essential Oil On Anxiety during Magnetic Resonance Imaging in Spinal disorder Imam Khomeini Hospital Saghez,2018
Public title
Effect of Aromatherapy with Citrus aurantium Essential Oil On Anxiety during Magnetic Resonance Imaging in Spinal disorder
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Patients aged 65-18 years old, lack of specific illness (allergy, olfactory disorder, anxiety disorder), lack of psychotropic drugs, lack of respiratory problems, non-performing magnetic resonance imaging, outpatients, patients with spinal disorders (neck and waist) ) And pituitary abnormalities (scoliosis, kyphosis, lordosis), mild to moderate anxiety in both control and intervention groups.
Exclusion criteria:
Any medical problem or required surgical interventions in medicine during the execution of the study, nausea and vomiting, and sensitivity to aromas of sour orange, dissatisfaction after each inhalation, dropped out of the study and an unwillingness to continue participation in the study for any reason, having severe anxiety , Generalized anxiety disorder, compulsive obsession, fear of closed space and social fear
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
60
Actual sample size reached:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Randomized and randomized drawings
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
Kurdistan University of Medical Sciences
Street address
Kurdistan University of Medical Sciences, after Qods Hospital, Sanandaj
City
Sanandaj
Province
Kurdistan
Postal code
13446-66177
Approval date
2018-01-31, 1396/11/11
Ethics committee reference number
IR.MUK.REC.1396.329
Health conditions studied
1
Description of health condition studied
Anxiety during magnetic field imaging
ICD-10 code
F41.1
ICD-10 code description
Generalized anxiety disorder
Primary outcomes
1
Description
Anxiety during magnetic field imaging
Timepoint
During magnetic field scan
Method of measurement
MRI-AQ
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Aromatic notes of spring flavor
Category
Treatment - Other
2
Description
Control group: Standard care center
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Ahani Nishtaman
Street address
Nursing Avenue، Imam Khomeini Hospital
City
Saghez
Province
Kurdistan
Postal code
66816-45747
Phone
+98 87 3622 4444
Email
N.Ahani63@muk.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Ahani Nishtaman
Street address
Kurdistan University of Medical Sciences, after Qods Hospital, Sanandaj
City
sanandaj
Province
Kurdistan
Postal code
66177-13446
Phone
+98 87 3366 4645
Fax
+98 87 3366 0092
Email
N.Ahani63@muk.ac.ir
Grant name
Kurdistan University of Medical Sciences
Grant code / Reference number
305
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sanandaj University of Medical Sciences
Proportion provided by this source
100
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
Sanandaj University of Medical Sciences
Full name of responsible person
Ahani Nishtaman
Position
Senior Care Nursing Student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Kurdistan University of Medical Sciences, after Qods Hospital, Sanandaj
City
Sanandaj
Province
Kurdistan
Postal code
66617713446
Phone
+98 87 3366 4645
Fax
+98 87 3366 0092
Email
N.Ahani63@muk.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Salehi Kamal
Position
Ph.D. in Nursing
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Kurdistan University of Medical Sciences, after Qods Hospital, Sanandaj
City
Sanandaj
Province
Kurdistan
Postal code
66177-13446
Phone
+98 87 3366 4645
Fax
+98 87 3366 0092
Email
N.Ahani63@muk.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Ahani Nishtaman
Position
Senior Care Nursing Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Kurdistan University of Medical Sciences, after Qods Hospital, Sanandaj
City
Sanandaj
Province
Kurdistan
Postal code
66177-13446
Phone
+98 87 3366 4645
Fax
+98 87 3366 0092
Email
N.Ahani63@muk.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available