Comparison of the concurrent effects of inhalation aromatherapy with Damask Rose and Lavender essential oils on the anesthetic drugs consumption in patients undergoing donor dressing change
Determining the concurrent effects of inhalation aromatherapy with Damask Rose and Lavender essential oils on the anesthetic drugs consumption and BIS scores in patients undergoing donor dressing change.
Design
A randomized controlled trial with control group, parallel, without blinding, using random sequences generated by SPSS software.
Settings and conduct
This study will be conducted in the burn unit of Imam Reza Hospital in Mashhad. Patients of the intervention group inhale Damask Rose and Lavender essential oils before change dressing, then anesthetic drugs are injected until the level of brain activity reaches the standard level. In the control group, anesthetic drugs will be administered without inhalation. Vital signs, respiratory indicators, and brain activity levels are monitored by monitoring, pulse oximetry, capnography and BIS.
Participants/Inclusion and exclusion criteria
Inclusion: Patients with second and third grade of burns, skin grafts at the burn site, donor anterior femur and filling the consent form.
Exclusion: sensitivity to inhalation of Damask Rose and Lavender essential oils and the occurrence of special medical conditions.
Intervention groups
The Patients of the intervention group will inhale Damask Rose and Lavender essential oils before donor dressing change. Then anesthetic drugs are administered.
The control group will receive only anesthetic drugs before donor dressing change.
Main outcome variables
The amount of anesthetic drugs required to reach the desired BIS and the duration of anesthesia in both groups will be recorded and compared.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171123037599N2
Registration date:2018-09-29, 1397/07/07
Registration timing:registered_while_recruiting
Last update:2018-09-29, 1397/07/07
Update count:0
Registration date
2018-09-29, 1397/07/07
Registrant information
Name
Razieh Froutan
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3881 4241
Email address
froutanr@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-08-25, 1397/06/03
Expected recruitment end date
2019-07-22, 1398/04/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the concurrent effects of inhalation aromatherapy with Damask Rose and Lavender essential oils on the anesthetic drugs consumption in patients undergoing donor dressing change
Public title
The concurrent effects of inhalation aromatherapy with Damask Rose and Lavender essential oils on the amount of anesthetic drugs consumption in patients undergoing donor place dressing change
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with second and third-degree burns
Need to skin graft
Donor location in the anterior femur
Filling out the informed consent
Exclusion criteria:
Being sensitive to inhalation of Lavender and Damask Rose
Occurrence of special medical conditions
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Random assignment is applied using random sequences generated by SPSS software to assign patients to intervention and control groups.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
Ebne- Sina Street, School of Nursing and Midwifery, Mashhad,Iran.
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Approval date
2018-07-30, 1397/05/08
Ethics committee reference number
IR.MUMS.NURSE.REC.1397.027
Health conditions studied
1
Description of health condition studied
Burn
ICD-10 code
T30.2
ICD-10 code description
Burn of second degree, body region unspecified
Primary outcomes
1
Description
Reducing anesthetic drug consumption in patients undergoing donor dressing change
Timepoint
The amount of anesthetic drugs consumption every 45 seconds after beginning the sedation.
Method of measurement
milligram
2
Description
Measuring the brain activity using BIS device connected to the patient.
Timepoint
Every five minutes after sedation begins, by an technician.
Method of measurement
By reading the BIS score on device.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Before changing the donor's dressing, patients will inhale 5 drops of Damask Rose (40%) and 7 drops of Lavender (10%) essential oils concurrently but with two separate aerators. Anesthetic drugs (midazolam, fentanil and ketamine) are administered until the level of brain activity is reached to the standard level that is measured by the BIS (Bispectral index).
Category
Other
2
Description
Control group: Before changing the donor's dressing, anesthetic drugs (midazolam, fentanyl and ketamine) are administered until the level of brain activity is reached to the standard level by the BIS (Bispectral index).
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza hospital
Full name of responsible person
Razieh Froutan
Street address
Nursing faculty,Ebn-e Sina Street ,Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913119
Phone
+98 51 3859 1511
Email
froutanr@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Deputy of Research and Technology
Street address
Ghoreishi building,Daneshgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913119
Phone
+98 51 3841 2081
Email
froutanr@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Razieh Froutan
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Ebne-Sina Street Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
froutanr@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Razieh Froutan
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Ebne-Sina Street,Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3881 4241
Email
froutanr@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Razieh Froutan
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Ebne-Sina Street,Mashhad,Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3881 4241
Email
froutanr@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
Consent form sample analysis method study result final manuscript
When the data will become available and for how long
One year after publication
To whom data/document is available
academic researcher by demand
Under which criteria data/document could be used
for systematic reviews and meta-analysis
From where data/document is obtainable
email:froutanr@mums.ac.ir
What processes are involved for a request to access data/document