Determination of the effect of aromatic massage with aromatic oil of Lavender and Chamomile on reducing anxiety and improving sleep quality in patients with burns
Design
Randomized,Semi-experimental study with control group,, with parallel groups,
Settings and conduct
On Iranian adult patients with burns admitted to the wards of women and men, the burn medical training center of Shahid Motahari Hospital affiliated to the University of Iran
Participants/Inclusion and exclusion criteria
Entry requirements
Age over 18 years
Awareness of time and place
Being able to speak and understand Persian language
Percentage of burns between 10-45% recorded in the case
Skin healthy Skin or back areas
Lack of septicemia symptoms with regard to file information
It's been 72 hours since burn
Lack of physical disability
Degree 2 and 3 burns recorded in the case
The absence of mental disorder in the past and past recorded in the case
No history of asthma and allergies to plants
No history of blood pressure and migraine recorded in the file
Absence of self-immolation
Lack of pregnancy
;Conditions for not admitting to study
Sepsis
Removal of the skin of healthy legs or back
Sensitivity to massage oils
Intervention groups
The control group is under the daily care of the department
Massage group with aromatic oils, in addition to daily care of the department, is under aromatherapy massage with aromatic oils of lavender and chamomile
The placebo group, in addition to day care, undergoes massage with baby oil
Main outcome variables
The effectiveness of the aromatic herbal remedy with aromatic oil of lavender and chamomile reduces anxiety and improves the quality of sleep in patients with burns, potentially reducing the use of anti-anxiety and hypnotic drugs and this method is a complementary non-pharmacological method for patients. Burn should be recommended.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180120038444N1
Registration date:2018-01-27, 1396/11/07
Registration timing:prospective
Last update:2018-01-27, 1396/11/07
Update count:0
Registration date
2018-01-27, 1396/11/07
Registrant information
Name
Farzaneh Ameri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4365 1000
Email address
ameri.f@tak.iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-03-10, 1396/12/19
Expected recruitment end date
2018-07-10, 1397/04/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of aromatic massage of lavender and chamomile on anxiety and sleep quality of patients with burns
Public title
Effect of aromatic massage of lavender and chamomile on anxiety and sleep quality of patients with burns
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 18 years
Awareness of time and place
Ability to speak and understand Persian language
Percentage of burns between 10-45% recorded in the file
Skin healthy areas of the leg or back
Lack of septicemia symptoms with regard to file information
72 hours after burn
Lack of physical disability
Degree 2 and 3 burns recorded in the case
Lack of mental disorder present and past recorded in the case
No history of asthma and allergies to plants
No history of blood pressure and migraine recorded in the file
Absence of self-immolation
Lack of pregnancy
Exclusion criteria:
The sample's reluctance to continue cooperation
Sepsis in the study
Removal of the skin in healthy areas of the leg or back during the intervention
Sensitivity to massage oils used during the study
Patient's death
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Data analyser
Sample size
Target sample size:
105
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization with 4-card blocking
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Iran University of Medical Sciences, Shahid Hemmat Highway
City
Tehran
Province
Tehran
Postal code
14665-354
Approval date
2017-12-09, 1396/09/18
Ethics committee reference number
1396.9413686003
Health conditions studied
1
Description of health condition studied
Burn
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
"The effect of aromatic massage with aromatic oil of lavender and chamomile on reducing anxiety and improving the quality of sleep in patients with burns", the primary outcome is the anxiety score in the Spielberger questionnaire and Pittsburgh Sleep Quality Score.
Timepoint
Anxiety and quality of sleep are performed at the beginning of the study (before the intervention) and three days later (end of the intervention).
Measurement of respiratory rate and heart rate in the first day (before and after intervention), second (before and after intervention) and third (before and after intervention)
Method of measurement
Heart rate with digital pulse oximeter and manual breathing rate with clock aid
Intervention groups
1
Description
Intervention group: Intervention group: Under massage with aromatic chamomile and lavender oil (2 drops of pure lavender essential oil and 2 drops of pure chamomile essential oil, prepared from yellow firm, diluted in 30 cc of base oil of grape seed) on areas with healthy skin (legs Foot, back), 10 to 15 cc for 20 minutes, control group: day care group, placebo group: under baby massage with healthy skin (legs, back), 10 to 15 centimeters C, for 20 minutes
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Motahari Hospital in Tehran
Full name of responsible person
Mostafa Deh Madhayei
Street address
Tehran Province, Tehran, District 3, Vanak، Rashid Yasemi St
City
Tehran
Province
Tehran
Postal code
1454638797
Phone
+98 21 8877 0031
Email
hospital.motahari@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Deputy Research and Technology
Street address
Iran University of Medical Sciences,Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 1021
Email
research@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Farzaneh Ameri
Position
Master of Science nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery ,Rashid Yasemi St, Tehran
City
Tehran
Province
Tehran
Postal code
1996713883
Phone
+98 21 4365 1000
Email
Ameri.f@tak.iums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Farzaneh Ameri
Position
master of science nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Rashid Yasemi St,Tehran
City
Tehran
Province
Tehran
Postal code
1996713883
Phone
+98 21 4365 1000
Email
Ameri.f@tak.iums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Farzaneh Ameri
Position
Master of science nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Rashid Yasemi St
City
Tehran
Province
Tehran
Postal code
1996713883
Phone
+98 21 4365 1000
Email
Ameri.f@tak.iums.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
Yes - There is a plan to make this available
Title and more details about the data/document
Total non-Identifiable Data, the Potential of the People Sharing
When the data will become available and for how long
Start Access 2018/5
To whom data/document is available
Professors and Students
Under which criteria data/document could be used
-
From where data/document is obtainable
ameri.f@tak.iums.ac.ir
What processes are involved for a request to access data/document
Request Via E-mail and Respond by Email Within one Week To Do