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
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
Design
Clinical trial with control group, with parallel groups, double-blind, randomized, phase 2-3 on 68 patients, random number table is used for randomization.
Settings and conduct
all adult patients with reduced LOC hospitalized in the special care departments of neurosurgery, central special care and stroke and after special care of Namazi and Shahid Rajaei hospitals affiliated to Shiraz University of Medical Sciences who meet the conditions for entering the study (with their informed consent). Then the people are divided into 2 groups by random allocation method and their Glasgow coma score is checked half an hour before each intervention and the intervention will be carried out and after each intervention the Glasgow score is also measured. The person who evaluates the LOC and the person who analyzes the data in this study are completely blinded and unaware.
Participants/Inclusion and exclusion criteria
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 and Stroke, 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, Respiratory allergies or allergies to plant extracts.
Intervention groups
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.
Main outcome variables
Glasgow coma score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221203056699N1
Registration date:2022-12-31, 1401/10/10
Registration timing:registered_while_recruiting
Last update:2022-12-31, 1401/10/10
Update count:1
Registration date
2022-12-31, 1401/10/10
Registrant information
Name
Zahra Ranjbar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3720 5242
Email address
zahra_ranjbar@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-12-21, 1401/09/30
Expected recruitment end date
2023-02-19, 1401/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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
Public title
Inhaling Sour Lemon Essential Essence and Level of Consciousness
Purpose
Supportive
Inclusion/Exclusion criteria
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.
Age
From 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
Care provider
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
68
Randomization (investigator's opinion)
Randomized
Randomization description
The random allocation method in this study will be the permutation block method of 4 such that A represents the person who receives the intervention and B represents the person who receives the control. In this method, considering blocks of 4, so that the total number of possible permutations is equal to 6, including:
ABAB, BABA, AABB, BBAA, ABBA, BAAB
Then, by using the table of random numbers, the desired random list of 68 items, which includes 17 blocks of 4 items (total number of samples68 = 4 x 17) is generated and the order of assigning each of the methods to each of the study's samples, is determined. After obtaining the code of ethics and IRCT, the first patient, having the inclusion criteria and using the available sampling method, is entered into the sequence list produced by someone other than the interventionist, and the people are entered into this list one after the other.
Blinding (investigator's opinion)
Double blinded
Blinding description
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).
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Zand St., University of Medical Sciences central building, 7th floor, Research and Technology Vice-Chancellor
City
Shiraz
Province
Fars
Postal code
7134814336
Approval date
2022-10-31, 1401/08/09
Ethics committee reference number
IR.SUMS.NUMIMG.REC.1401.079
Health conditions studied
1
Description of health condition studied
Decrease Level of Consciousness
ICD-10 code
G96.9
ICD-10 code description
Disorder of central nervous system, unspecified
Primary outcomes
1
Description
Level of Consciousness
Timepoint
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.
Method of measurement
Glasgow coma score
Secondary outcomes
empty
Intervention groups
1
Description
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.
Category
Treatment - Other
2
Description
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.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Namazi hospital
Full name of responsible person
Afshin Borhan Haghighi
Street address
Zand Ave, Namazi square, Namazi hospital
City
Shiraz
Province
Fars
Postal code
7193613311
Phone
+98 71 3647 4332
Email
nemazee_inf@sums.ac.ir
2
Recruitment center
Name of recruitment center
Rajayi hospital
Full name of responsible person
Golnar Sabetian
Street address
Chamran Blvd, before Niayesh Ave, Rajayi hospital
City
Shiraz
Province
Fars
Postal code
7194815711
Phone
+98 71 3636 4001
Email
rajaeehospital@sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Roxana Jan Ghorban
Street address
Namazi square, Hazrat Fatemeh nursing college
City
Shiraz
Province
Fars
Postal code
7193613119
Phone
+98 71 3647 4254
Fax
Email
janghorban@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Zahra Ranjbar
Position
Masters Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Zand Ave, Namazi Square, Hazrat Fatemeh Nursing College
City
Shiraz
Province
Fars
Postal code
7193613119
Phone
+98 71 3647 4254
Email
zahra_ranjbar@sums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mahnaz Rakhshan
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Namazi Square, Hazrat Fatemeh Nursing College
City
Shiraz
Province
Fars
Postal code
7193613119
Phone
+98 71 3647 4254
Email
rakhshanm@sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Zahra Ranjbar
Position
Masters Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Namazi Square, Hazrat Fatemeh Nursing College
City
Shiraz
Province
Fars
Postal code
7193613119
Phone
+98 71 3647 4254
Email
zahra_ranjbar@sums.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
Undecided - It is not yet known if there will be 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
No - There is not a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available