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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Protocol summary
Clinical trial with control group, with parallel groups, double-blind, randomized, phase 2-3 on 68 patients, random number table is used for randomization.
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.
ClinicalA clinical trial with a control group, with parallel groups, double-a blind strain, randomized, phase 2-3 on 68 patients, random number table is used for randomization by pouring paper into the number of special sections and randomly picking them.
کارآزمایی بالینی دارای گروه کنترل، با گروه های موازی، دو سویه کور، تصادفی شده، فاز2-3 بر روی 68 بیمار، برای تصادفی سازی از جدول اعداد تصادفی استفاده میشود.
کارآزمایی بالینی دارای گروه کنترل، با گروه های موازی، یک سویه کور، تصادفی شده، فاز2-3 بر روی 68 بیمار، برای تصادفی سازی از ریختن کاغذ به تعداد و شماره بخش های ویژه و خارج کردن تصادفی آن ها استفاده میشود.
کارآزمایی بالینی دارای گروه کنترل، با گروه های موازی، دویک سویه کور، تصادفی شده، فاز2-3 بر روی 68 بیمار، برای تصادفی سازی از جدول اعدادریختن کاغذ به تعداد و شماره بخش های ویژه و خارج کردن تصادفی آن ها استفاده میشود.
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.
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.
allThe research population will be adult patients with reduced LOClevel of consciousness hospitalized in the special care departmentsunits of neurosurgery, central special care and stroke and after special care of Namazi and Shahid Rajaei hospitals affiliated to Shiraz University of Medical SciencesHospital who meet the conditions for entering the study (withand declare their informed consent) to participate in the study. Then, the peoplespecial departments are divided into 2 groups by random allocation method, and their Glasgow coma score is checked half an hour before each intervention, the Glasgow coma score of the patients will be checked and the intervention will be carried outperformed, and after each intervention, the Glasgow score is alsoGCS will be measured. The person who evaluates the LOC and the person who analyzes the data in this study are completely blinded and unaware.
جامعه پژوهش را کلیه بیماران بزرگسال با کاهش سطح هوشیاری بستری در بخش های مراقبت ویژه نروسرجری، مراقبت های ویژه مرکزی و استروک و بعد از مراقبت ویژه بیمارستان های نمازی و شهید رجایی وابسته به دانشگاه علوم پزشکی شیراز خواهند بود که شرایط ورود به مطالعه را داشته باشند و رضایت آگاهانه خود را جهت شرکت در مطالعه اعلام کنند. سپس افراد با روش تخصیص تصادفی به 2 گروه تقسیم میشوند و نیم ساعت قبل از هر بار مداخله نمره کمای گلاسکو آنان بررسی شده و مداخله انجام خواهد شد و بعد از هربار مداخله نیز نمره گلاسکو اندازه گیری میشود. فردی که سطح هوشیاری را ارزیابی میکند و فرد تجزیه و تحلیل کننده داده ها در این مطالعه کاملا کورسازی شده و بی اطلاع می باشند.
جامعه پژوهش را کلیه بیماران بزرگسال با کاهش سطح هوشیاری بستری در بخش های مراقبت ویژه بیمارستان شهید رجایی وابسته به دانشگاه علوم پزشکی شیراز خواهد بود که شرایط ورود به مطالعه را داشته باشند و رضایت آگاهانه خود را جهت شرکت در مطالعه اعلام کنند. سپس بخش های ویژه با روش تخصیص تصادفی به 2 گروه تقسیم میشوند و نیم ساعت قبل از هر بار مداخله نمره کمای گلاسکو بیماران بررسی شده و مداخله انجام خواهد شد و بعد از هربار مداخله نیز نمره گلاسکو اندازه گیری میشود. فردی که سطح هوشیاری را ارزیابی میکند و فرد تجزیه و تحلیل کننده داده ها در این مطالعه کاملا کورسازی شده و بی اطلاع می باشند.
جامعه پژوهش را کلیه بیماران بزرگسال با کاهش سطح هوشیاری بستری در بخش های مراقبت ویژه نروسرجری، مراقبت های ویژه مرکزی و استروک و بعد از مراقبت ویژه بیمارستان های نمازی و شهید رجایی وابسته به دانشگاه علوم پزشکی شیراز خواهندخواهد بود که شرایط ورود به مطالعه را داشته باشند و رضایت آگاهانه خود را جهت شرکت در مطالعه اعلام کنند. سپس افرادبخش های ویژه با روش تخصیص تصادفی به 2 گروه تقسیم میشوند و نیم ساعت قبل از هر بار مداخله نمره کمای گلاسکو آنانبیماران بررسی شده و مداخله انجام خواهد شد و بعد از هربار مداخله نیز نمره گلاسکو اندازه گیری میشود. فردی که سطح هوشیاری را ارزیابی میکند و فرد تجزیه و تحلیل کننده داده ها در این مطالعه کاملا کورسازی شده و بی اطلاع می باشند.
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.
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.
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.
General information
Randomized
Not randomized
randnrand
Double blinded
Single blinded
doublsingl
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1
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68
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2023-02-19, 1401/11/30
2023-02-19 00:00:00
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2023-06-20, 1402/03/30
2023-06-20 00:00:00
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2023-06-20, 1402/03/30
2023-06-20 00:00:00
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Changing the research environment and study method during the implementation of intervention according to the existing conditions
Changing the research environment and study method during the implementation of intervention according to the existing conditions
empty
تغییر محیط پژوهش و روش مطالعه حین اجرای مداخله به اجبار بر حسب شرایط موجود
تغییر محیط پژوهش و روش مطالعه حین اجرای مداخله به اجبار بر حسب شرایط موجود
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.
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.
روش تخصیص تصادفی در این مطالعه روش بلوک جایگشتی 4 تایی خواهد بود به اینصورت که A نمایانگر فردیست که مداخله را دریافت می کند و B نماینده فردی است که کنترل را دریافت می کند. در این روش با در نظر گرفتن بلوک های 4 تایی، به طوری که تعداد کل جایگشت های ممکن برابر با 6 می باشد شامل:
ABAB BABA, AABB, BBAA, ABBA, BAAB,
سپس با استفاده از جدول اعداد تصادفی، لیست تصادفی 68 تایی مورد نظر که شامل 17 بلوک 4 تایی می شود (4*17=68 تعداد کل نمونه ها) تولید شده و ترتیب اختصاص هر یک از روش ها به هر یک از نمونه های شرکت کننده در مطالعه مشخص می شود. پس از اخذ کد اخلاق و IRCT اولین بیمار با داشتن معیار های ورود و به روش نمونه گیری در دسترس توسط فردی غیر از شخص مداخله گر وارد لیست توالی تولید شده می گردد و به ترتیب افراد در پی هم وارد این لیست می شوند.
روش تخصیص تصادفی در این مطالعه روش بلوک جایگشتی 4 تایی خواهد بود به اینصورت که A نمایانگر فردیست که مداخله را دریافت می کند و B نماینده فردی است که کنترل را دریافت می کند. در این روش با در نظر گرفتن بلوک های 4 تایی، به طوری که تعداد کل جایگشت های ممکن برابر با 6 می باشد شامل: ABAB BABA, AABB, BBAA, ABBA, BAAB, سپس با استفاده از جدول اعداد تصادفی، لیست تصادفی 68 تایی مورد نظر که شامل 17 بلوک 4 تایی می شود (4*17=68 تعداد کل نمونه ها) تولید شده و ترتیب اختصاص هر یک از روش ها به هر یک از نمونه های شرکت کننده در مطالعه مشخص می شود. پس از اخذ کد اخلاق و IRCT اولین بیمار با داشتن معیار های ورود و به روش نمونه گیری در دسترس توسط فردی غیر از شخص مداخله گر وارد لیست توالی تولید شده می گردد و به ترتیب افراد در پی هم وارد این لیست می شوند.
Recruitment centers
#1
Name of recruitment center - English: Namazi hospital
Name of recruitment center - Persian: بیمارستان نمازی
Full name of responsible person - English: Afshin Borhan Haghighi
Full name of responsible person - Persian: افشین برهان حقیقی
Street address - English: Zand Ave, Namazi square, Namazi hospital
Street address - Persian: خیابان زند، میدان نمازی، بیمارستان نمازی
City - English: Shiraz
City - Persian: شیراز
Province: Fars
Country: Iran (Islamic Republic of)
Postal code: 7193613311
Phone: +98 71 3647 4332
Fax:
Email: nemazee_inf@sums.ac.ir
Web page address:
Name of recruitment center - English: Rajayi hospital
Name of recruitment center - Persian: بیمارستان رجایی
Full name of responsible person - English: Golnar Sabetian
Full name of responsible person - Persian: گلنار ثابتیان
Street address - English: Chamran Blvd, before Niayesh Ave, Rajayi hospital
Street address - Persian: بلوار چمران، نرسیده به خیابان نیایش، بیمارستان رجایی
City - English: Shiraz
City - Persian: شیراز
Province: Fars
Country: Iran (Islamic Republic of)
Postal code: 7194815711
Phone: +98 71 3636 4001
Fax:
Email: rajaeehospital@sums.ac.ir
Web page address:
Name of recruitment center - English: NamaziRajayi hospital Name of recruitment center - Persian: بیمارستان نمازیرجایی Full name of responsible person - English: Afshin Borhan HaghighiGolnar Sabetian Full name of responsible person - Persian: افشین برهان حقیقیگلنار ثابتیان Street address - English: ZandChamran Blvd, before Niayesh Ave, Namazi square, NamaziRajayi hospital Street address - Persian: بلوار چمران، نرسیده به خیابان زند، میدان نمازینیایش، بیمارستان نمازیرجایی City - English: Shiraz City - Persian: شیراز Province: Fars Country: Iran (Islamic Republic of) Postal code: 71936133117194815711 Phone: +98 71 3647 43323636 4001 Fax: Email: nemazee_infrajaeehospital@sums.ac.ir Web page address:
#2
Name of recruitment center - English: Rajayi hospital
Name of recruitment center - Persian: بیمارستان رجایی
Full name of responsible person - English: Golnar Sabetian
Full name of responsible person - Persian: گلنار ثابتیان
Street address - English: Chamran Blvd, before Niayesh Ave, Rajayi hospital
Street address - Persian: بلوار چمران، نرسیده به خیابان نیایش، بیمارستان رجایی
City - English: Shiraz
City - Persian: شیراز
Province: Fars
Country: Iran (Islamic Republic of)
Postal code: 7194815711
Phone: +98 71 3636 4001
Fax:
Email: rajaeehospital@sums.ac.ir
Web page address:
Name of recruitment center - English: Rajayi hospital Name of recruitment center - Persian: بیمارستان رجایی Full name of responsible person - English: Golnar Sabetian Full name of responsible person - Persian: گلنار ثابتیان Street address - English: Chamran Blvd, before Niayesh Ave, Rajayi hospital Street address - Persian: بلوار چمران، نرسیده به خیابان نیایش، بیمارستان رجایی City - English: Shiraz City - Persian: شیراز Province: Fars Country: Iran (Islamic Republic of) Postal code: 7194815711 Phone: +98 71 3636 4001 Fax: Email: rajaeehospital@sums.ac.ir Web page address:
Protocol summary
Study aim
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
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.
Settings and conduct
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.
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 , 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.
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
Changing the research environment and study method during the implementation of intervention according to the existing conditions
Acronym
IRCT registration information
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
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
2023-02-19, 1401/11/30
Actual recruitment end date
2023-06-20, 1402/03/30
Trial completion date
2023-06-20, 1402/03/30
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
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
68
Actual sample size reached:
68
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single 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
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