Protocol summary
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Study aim
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Determine the effect of lemon essence on anxiety, physiological indices and post-operative nausea & vomiting in patients undergoing lower limb fractures surgeries
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Design
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A clinical trial with control group, parallel group randomized trial, a single blinded
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Settings and conduct
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Setting: Rajai, and Namazi hospitals, Data collector and statistician are blind.
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Participants/Inclusion and exclusion criteria
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The inclusion criteria would be having lower limb fracture surgery, being hospitalized in Orthopedic surgery Wards for 24 hours before surgery, being 18 years old or above, and being oriented to time, person and place. The patient has an asthma, a respiratory allergy or be sensitive to extracts of the plant, has olfactory problems, and nasal injury, being known case of psychological diseases, participated in previous studies received complementary and alternative interventions from a week before the intervention, transfer to ICU after surgery, requires postoperative ventilator, and died would be excluded.
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Intervention groups
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Intervention group: Take five drops of lemon essence on a cotton pad and attached to the patient's collar with a pin at a distance of 20 cm from the head. Aromatherapy starts in the morning of the lower limb fracture surgery and will be extended at two-hour intervals until the end of the surgery, in recovery and 16 hours after surgery.
Control group: Bitter almond oil, which is odorless, will be used in a similar way of the intervention group.
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Main outcome variables
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Anxiety, physiological indices and post-operative nausea & vomiting
General information
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Reason for update
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Change in the time of start the intervention and setting of study
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20130616013690N10
Registration date:
2021-07-24, 1400/05/02
Registration timing:
prospective
Last update:
2021-12-15, 1400/09/24
Update count:
1
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Registration date
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2021-07-24, 1400/05/02
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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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2021-12-16, 1400/09/25
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Expected recruitment end date
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2022-03-06, 1400/12/15
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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The effect of lemon essence on anxiety, physiological indices and post-operative nausea & vomiting in patients undergoing lower limb fractures surgeries
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Public title
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The effect of lemon essence on patients undergoing lower limb fractures surgeries
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Purpose
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Supportive
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Inclusion/Exclusion criteria
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Inclusion criteria:
Having Lower Limb Fracture Surgery
Hospitalization in orthopedic surgery Wards for 24 hours before surgery
Being 18 years old or above
Being oriented to time, person and place
Exclusion criteria:
Patient has an asthma, a respiratory allergy or be sensitive to extracts of the plant
The patient has olfactory problems, and nasal injury
Being known case of psychological diseases (major depression, anxiety, psychosis, etc.)
Participated in previous studies received complementary and alternative interventions from a week before the intervention
Transfer to ICU after surgery
Requires postoperative ventilator
Death of the patient
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Age
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From 18 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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- Care provider
- Investigator
- Outcome assessor
- Data analyser
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Sample size
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Target sample size:
90
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Firstly, Rajai and Namazi hospitals are selected as two separate strata. Then, using Winpepi software and balanced randomization of separate strata, a list of random allocation is set for 90 patients. Therefore, according to the list in each stratum (hospital), 45 patients are randomly divided into the intervention or control groups.
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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To conducting blinding, assistant researcher who collects data, as well as statistician who analyzes the data, are blinded to the groups and the assignment of individuals in the groups.
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Placebo
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Not used
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Assignment
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Parallel
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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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2021-06-08, 1400/03/18
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Ethics committee reference number
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IR.SUMS.NUMIMG.REC.1400.001
Health conditions studied
1
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Description of health condition studied
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Lower limb fracture surgery
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ICD-10 code
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T84.11
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ICD-10 code description
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Breakdown (mechanical) of internal fixation device of bones of limb
Primary outcomes
1
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Description
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Anxiety
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Timepoint
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In the morning of the surgery and the day after surgery at 8 A.M.
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Method of measurement
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State-Trait Anxiety Inventory
2
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Description
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Physiological indices (blood pressure, SPO2, respiration, temperature and pain)
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Timepoint
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In the morning of surgery, In the post-operative anesthesia care unit, after entering the orthopedic ward, and 4, 8, 12 and 16 hours after surgery
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Method of measurement
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Digital blood pressure monitors, Pulse Oximeter, Chronometer, MASTECH Non Contact Infrared Medical Thermometer and numeric analogue pain
3
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Description
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Neurovascular assessment of lower limb
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Timepoint
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In the morning of surgery, after entering the orthopedic ward, and 4, 8, 12 and 16 hours after surgery
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Method of measurement
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WACHS Neurovascular Observation Charts
4
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Description
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Post-operative nausea and vomiting
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Timepoint
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In the post-operative anesthesia care unit, 4, 8, 12 and 16 hours after surgery
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Method of measurement
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Rhodes Index of Nausea, Vomiting and Retching and Numeric Analogue scale
Intervention groups
1
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Description
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Intervention group: Take five drops of lemon essence on a cotton pad and attached to the patient's collar with a pin at a distance of 20 cm from the head. Aromatherapy starts in the morning of the lower limb fracture surgery and will be extended at two-hour intervals until the end of the surgery, in recovery room and 16 hours after surgery.
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Category
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Prevention
2
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Description
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Control group: Bitter almond oil, which is odorless, will be used in a similar way of the intervention group.
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Category
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Other
1
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Sponsor
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Grant name
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23210
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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No
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Title of funding source
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Shiraz 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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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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Primary outcomes would be shared.
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When the data will become available and for how long
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Starting 6 months after publication article
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To whom data/document is available
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People and researchers working in academic institutions
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Under which criteria data/document could be used
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Data are provided for information only.
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From where data/document is obtainable
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Data is available via email rambodma@yahoo.com.
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What processes are involved for a request to access data/document
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Data is available via email rambodma@yahoo.com.
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Comments
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