Investigation on the effectiveness inhalation aromatherapy with Lavender essential oil versus placebo on the anxiety of patients with burns. a double blinded randomized clinical trial
Objective: effects of inhalation aromatherapy with Lavender essential oil on the anxiety of patients with burns. Design: Double blinded randomized clinical trial. Setting and conduct: the patients with following criteria will be enrolled into the study; age 18 to 65 years; b) burns degree of 2 or 2 and 3 and with 15 to 60 percent burn level; c) lack of inhalation burns; d) lack of allergy or respiratory diseases; e) lack of narcotic addiction or drug abuse. Exclusion criteria included: Lack of patient cooperation during the intervention for any reason; creation dangerous condition of disease during the intervention; allergy to inhalation of Lavender essential oil during the intervention. Intervention 1: in the first night, anxiety of patients will be controlled. Then, for 20 minutes patients inhale 2 drops of Lavender essential oil 2% produced by Hyrad Company which was poured onto 10×10 cm gauze attached to collar of patients' shirt. The anxiety of the patients will be controlled again 20 minutes later . Intervention 2: in the first night, anxiety of patients will be controlled. Then, for 20 minutes patients inhale 2 drops of distilled water as placebo which was poured onto 10×10 cm gauze attached to collar of patients' shirt. The anxiety of the patients will be controlled again 20 minutes later. In the second and third night, the intervention will be implemented in the same way. Main outcome measures: Anxiety will be measured by Spielberger questionnaire.
General information
Acronym
-
IRCT registration information
IRCT registration number:IRCT2013042413110N1
Registration date:2015-06-27, 1394/04/06
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-06-27, 1394/04/06
Registrant information
Name
Mehdi Harorani
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 3417 3505
Email address
m.harorany@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Arak University of Medical Sciences
Expected recruitment start date
2015-05-22, 1394/03/01
Expected recruitment end date
2015-09-23, 1394/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation on the effectiveness inhalation aromatherapy with Lavender essential oil versus placebo on the anxiety of patients with burns. a double blinded randomized clinical trial
Public title
Investigation on the effectiveness inhalation aromatherapy with Lavender essential oil versus placebo on the anxiety of patients with burns. a double blinded randomized clinical trial
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: age 18 to 65 years; burns degree of 2 or 2 and 3 with 15 to 60 percent burn level; stability of hemodynamic status; lack of inhalation burns; lack of allergy or respiratory diseases; lack of narcotic addiction or drug abuse. Exclusion criteria: Lack of patient cooperation during the intervention for any reason; creation dangerous conditions of disease during the intervention; allergy to inhalation of Lavender Essential Oil during the intervention.
Age
From 18 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double 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 Arak University of Medical Sciences
Street address
Vice Chancellery For Research And Education, Pardis Site Of University Of Medical Sciences, Basij Sq, Arak
City
Arak
Postal code
38481-76941
Approval date
2015-04-20, 1394/01/31
Ethics committee reference number
p/2/94c6276
Health conditions studied
1
Description of health condition studied
Burns
ICD-10 code
T31.2, T31
ICD-10 code description
Burns involving 20-29% of body surface, Burns involving 30-39% of body surface, Burns involving 40-49% of body surface, Burns involving 50-59% of body surface, Burns involving 60-69% of body surface
2
Description of health condition studied
Anxiety
ICD-10 code
F38
ICD-10 code description
Any other mood disorders that do not justify classification to F30-F34, because they are not of sufficient severity or duration
Primary outcomes
1
Description
Anxiety
Timepoint
Before and 20 minutes after inhalation of lavender (experimental group) or distilled water (control group) for three consecutive nights
Method of measurement
Spielberger questionnaire
Secondary outcomes
1
Description
-
Timepoint
-
Method of measurement
-
Intervention groups
1
Description
the patients for 20 minutes inhale 2 drops of Lavender essential oil 2% produced by Hyrad Company which was poured on to 10×10 cm gauze attached to collar of patients' shirt. The anxiety of the patients will be controlled again 20 minutes later. In the second and third night, the intervention will be implemented in the same way.
Category
Treatment - Drugs
2
Description
for 20 minutes patients inhale 2 drops of distilled water as placebo which was poured on to 10×10 cm gauze attached to collar of patients' shirt. The anxiety of the patients will be controlled again 20 minutes later. In the second and third night, the intervention will be implemented in the same way.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Valiasr Hospital Arak
Full name of responsible person
Mehdi Harorani
Street address
Arak, Valiasr Hospital
City
Arak
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-Chancellor of Education and Research Arak University of Medical Sciences
Full name of responsible person
Dr. Ali Ghazavi
Street address
Vice Chancellery For Research And Education, Pardis Site Of University Of Medical Sciences, Basij Sq, Arak
City
Arak
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-Chancellor of Education and Research Arak 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
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University Of Medical Sciences
Full name of responsible person
Mehdi Harorani
Position
Master of Science in Nursing
Other areas of specialty/work
Street address
Valiasr Hospital, Valieasr Square, Arak
City
Arak
Postal code
38149 - 5 - 7558
Phone
+98 86 3222 2003
Fax
+98 86 3223 1283
Email
m.harorani@yahoo.com; m.harorani@gmaile.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Valiasr Hospital Arak
Full name of responsible person
Mehdi Harorani
Position
Master of Science in Nursing
Other areas of specialty/work
Street address
Valiasr Hospital, Valiasr Square, Arak
City
Arak
Postal code
38149 - 5 - 7558
Phone
+98 86 3222 2003
Fax
+98 86 3223 1283
Email
m.harorani@yahoo.com; m.harorani@gmaile.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)