Protocol summary
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Study aim
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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
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Design
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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.
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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
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Intervention groups
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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
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Main outcome variables
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Anxiety
General information
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Reason for update
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Acronym
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IRCT registration information
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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
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Registration date
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2018-02-13, 1396/11/24
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2018-02-20, 1396/12/01
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Expected recruitment end date
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2018-05-22, 1397/03/01
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Actual recruitment start date
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2018-02-20, 1396/12/01
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Actual recruitment end date
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2018-05-22, 1397/03/01
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Trial completion date
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empty
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Scientific title
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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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Public title
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Effect of Aromatherapy with Citrus aurantium Essential Oil On Anxiety during Magnetic Resonance Imaging in Spinal disorder
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Purpose
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Health service research
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Inclusion/Exclusion criteria
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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
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Age
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From 18 years old to 65 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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No information
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Sample size
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Target sample size:
60
Actual sample size reached:
60
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Randomized and randomized drawings
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Other
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2018-01-31, 1396/11/11
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Ethics committee reference number
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IR.MUK.REC.1396.329
Health conditions studied
1
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Description of health condition studied
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Anxiety during magnetic field imaging
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ICD-10 code
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F41.1
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ICD-10 code description
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Generalized anxiety disorder
Primary outcomes
1
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Description
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Anxiety during magnetic field imaging
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Timepoint
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During magnetic field scan
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Method of measurement
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MRI-AQ
Intervention groups
1
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Description
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Intervention group: Aromatic notes of spring flavor
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Category
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Treatment - Other
2
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Description
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Control group: Standard care center
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Category
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Treatment - Other
1
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Sponsor
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Grant name
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Kurdistan University of Medical Sciences
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Grant code / Reference number
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305
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Sanandaj University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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No - There is not a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available