Patients who have Inclusion criteria were as simple random sampling are selected, so that the 120 paper, a color, a shape that the 40 by the letter A and 40 letters B and 40 letter C written so that their letters be covered. Each of the participants in an envelope at random and without replacement will choose and thus in one of the groups A, B, and C will be. About half an hour before dressing, visual analogue scale of pain intensity in patients with burns self to be checked. Then for half an hour intervention is done so that the groups inhalation aromatherapy, intervention in this case would be the principal investigator of 10 drops of essential oil of Astkhdvs in Group A and 10 drops of distilled water in Group B with dropper on gas attached to clothing or pillows participation and group C will receive treatment and routine care. Also the number of housing request by any of the subjects to be checked 12 hours after the intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017030632129N3
Registration date:2017-05-17, 1396/02/27
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-05-17, 1396/02/27
Registrant information
Name
Azim Azizi
Name of organization / entity
Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 3838 0150
Email address
a.azizi@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research and Technology of Hamadan University of Medical Sciences
Expected recruitment start date
2017-04-21, 1396/02/01
Expected recruitment end date
2017-08-22, 1396/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of inhalation aromatherapy with lavender extract on pain and anxiety in burn patients: a randomized clinical trial
Public title
Extracts of lavender on pain and anxiety in patients with burns
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: degree burns 2, alertness naturally able to speak clearly, confirmed the doctor's lack of a ban on entry to the study, lack of sensitivity to herbal medicines, non-drug addiction (based on patient testimony), lack of brain tumor, stroke head, epilepsy, lack of mental disorders, there is no problem of smell, lack of focus pain of others, the use of perfume by the patient simultaneously, burns 30% of body surface area based on the criteria Lund and Browder, 48 hours of patient past the hospital, the fire does not burn because, aged 18 to 55 years. Exclusion criteria: Use of herbal medicines by the patients, creating any disturbance of smell, causing respiratory problems and allergic withdraw from the study at any stage of the study, participated in a similar study at the same time (aromatherapy), based on the scale, visual analogue pain less than 3, less patient anxiety score of 20 on a scale of Der Burger.
Age
From 18 years old to 55 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hamedan University of Medical Sciences
Street address
Hamadan University of Medical Science, Shahid Fahmide boulevard, Hamadan
City
Hamadan
Postal code
00988138380150
Approval date
2017-03-05, 1395/12/15
Ethics committee reference number
IR.UMSHA.REC.1395.591
Health conditions studied
1
Description of health condition studied
Burn
ICD-10 code
T20-T25
ICD-10 code description
Burns and corrosions of external body surface
Primary outcomes
1
Description
pain
Timepoint
3 times in 3 days
Method of measurement
pain Chart
2
Description
Anxiety
Timepoint
3 times in 3 days
Method of measurement
Spielberger questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
The scent of lavender is used in the intervention group
Category
Treatment - Other
2
Description
The scent of lavender is used in the intervention group
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Besat hospital
Full name of responsible person
Atefe lashani
Street address
Hamadan, Babak Crossroads, Besat hospital
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research and Technology of Hamadan University of Medical Sciences
Full name of responsible person
Saeid Bashirian
Street address
Hamadan University of Medical Science, Shahid Fahmide boulevard, Hamadan
City
Hamadan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research and Technology of Hamadan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Hamadan University of Medical Sciences
Full name of responsible person
Azim Azizi
Position
PhD in Nursing
Other areas of specialty/work
Street address
Hamadan University of Medical Science, Shahid Fahmide boulvard
City
Hamadan
Postal code
00988138380150
Phone
+98 81 3838 0150
Fax
Email
a.azizi@umsha.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamadan University of Medical Science
Full name of responsible person
Azim Azizi
Position
PhD in nursing
Other areas of specialty/work
Street address
Hamadan University of Medical Science, Shahid Fahmide boulevard
City
Hamadan
Postal code
00988138380150
Phone
+98 81 3838 0150
Fax
Email
a.azizi@umsh.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Full name of responsible person
Position
Other areas of specialty/work
Street address
City
Postal code
00988138380150
Phone
+98 81 3838 0150
Fax
Email
a.azizi@umsh.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)