Protocol summary
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Study aim
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Investigating the effect of lemon essential oil inhalation on the level of consciousness of adult patients with mild to moderate loss of consciousness admitted to special departments of the hospital
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Design
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A clinical trial with a control group, with parallel groups, a blind strain, randomized, phase 2-3 on 68 patients, is used for randomization by pouring paper into the number of special sections and randomly picking them.
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Settings and conduct
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The research population will be adult patients with reduced level of consciousness hospitalized in the special care units of Shahid Rajaei Hospital who meet the conditions for entering the study and declare their informed consent to participate in the study. Then, the special departments are divided into 2 groups by random allocation method, and half an hour before each intervention, the Glasgow coma score of the patients will be checked and the intervention will be performed, and after each intervention, the GCS will be measured. The person who evaluates the LOC and the person who analyzes the data in this study are blinded.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: Patients with decreased level of consciousness, that at least one week has passed sinse their injury or brain damage, (GCS 9-14) due to Head Trauma, Neurological Diseases , Informed consent of the patient or her/his first degree relatives to participate in the study ;
Exclusion criteria: receiving sedatives, limb paralysis such as Spinal Cord Lesions, Intubated or tracheostomy patients, allergies to plant extracts.
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Intervention groups
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The intervention groups inhale 5 drops of lemon essential oil on a cotton pad in a porous box at a distance of 20-40 cm, 3 times a day and for 20 minutes each time, during 5 days. The control group will inhale normal saline under the same conditions.
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Main outcome variables
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Glasgow coma score
General information
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Reason for update
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Changing the research environment and study method during the implementation of intervention according to the existing conditions
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20221203056699N1
Registration date:
2022-12-31, 1401/10/10
Registration timing:
prospective
Last update:
2023-09-14, 1402/06/23
Update count:
1
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Registration date
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2022-12-31, 1401/10/10
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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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2022-12-21, 1401/09/30
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Expected recruitment end date
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2023-02-19, 1401/11/30
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Actual recruitment start date
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2023-02-19, 1401/11/30
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Actual recruitment end date
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2023-06-20, 1402/03/30
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Trial completion date
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2023-06-20, 1402/03/30
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Scientific title
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Comparison of the Effectiveness of Inhaling Sour Lemon Essential Essence and Placebo on the Level of Consciousness in Adult Patients with Mild to Moderate Decreased Level of Consciousness
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Public title
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Inhaling Sour Lemon Essential Essence and Level of Consciousness
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Purpose
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Supportive
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Inclusion/Exclusion criteria
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Inclusion criteria:
Patients with decreased level of consciousness , that at least one week has passed sinse their injury or brain damage.
18 years old and older age
Mild to Moderate level of consciousness disorder (GCS 9-14) due to Head Trauma, Neurological Diseases and Stroke.
Informed consent of the patient or her/his first degree relatives to participate in the study.
Exclusion criteria:
Patients with decreased level of consciousness, as a result of receiving sedatives.
Patients with limb paralysis such as Spinal Cord Lesions, due to movement disorders.
Intubated or tracheostomy patients.
Respiratory allergies or allergies to plant extracts.
Problems related to smell and nose injury.
Participating in previous studies receiving Complementary and Alternative Medicine interventions from one week before our intervention.
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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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2-3
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Groups that have been masked
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- Outcome assessor
- Data analyser
- Data and Safety Monitoring Board
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Sample size
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Target sample size:
68
Actual sample size reached:
68
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Randomization (investigator's opinion)
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Not randomized
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Randomization description
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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The intervention is carried out by a research assistant other than the researcher evaluating the Glasgow coma score before and after the intervention. As a result, the impact assessment researcher is unaware of the type of intervention. Also, as much as possible, the clinical caregiver is kept unaware of the type of intervention. The data analyst will do his work based on the anonymous codes and does not know the type of intervention performed on each code that is a patient. The legal guardian of the patient is fully aware of the study and its purpose, but they are not informed about the type of essential oil (lemon or normal saline).
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Placebo
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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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2022-10-31, 1401/08/09
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Ethics committee reference number
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IR.SUMS.NUMIMG.REC.1401.079
Health conditions studied
1
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Description of health condition studied
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Decrease Level of Consciousness
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ICD-10 code
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G96.9
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ICD-10 code description
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Disorder of central nervous system, unspecified
Primary outcomes
1
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Description
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Level of Consciousness
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Timepoint
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The level of consciousness will be measured at the beginning of the study (before the start of the intervention) and every first 5 days, as well as on the eighth day (three days after the last day of the intervention), half an hour before each intervention and 10 minutes after each intervention.
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Method of measurement
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Glasgow coma score
Intervention groups
1
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Description
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intervention will be done within 5 days; 3 times a day and 20 minutes each time (in order to compensate for limitation of the hospitalization time, the frequency of the intervention has been increased to three times). In this regard, for the intervention group, the researcher first placed cotton soaked with 5 drops of 68.2% lemon essential oil from Kashan Barij essence medicine company, in a porous box at a distance of 20-40 cm from the patient and every day at 8:30, 12:30, 16:30 will be used and inhaled.
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Category
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Treatment - Other
2
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Description
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within 5 days; 3 times a day and 20 minutes each time, for the control group, by the researcher, cotton soaked with 5 drops of normal saline (as a placebo) was placed in a porous box at a distance of 20-40 cm from the patient and every day at 8:30, 12 :30, 16:30 will be used and inhaled.
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Category
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Placebo
1
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Sponsor
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Grant name
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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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Yes
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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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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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Undecided - It is not yet known if there will be 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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No - There is not 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