The goal of this study is evaluating the effects of inhalation of Lavender essential oil on the pain of open-heart surgery. The main complaint of patients after open-heart surgery is chest pain. Due to the side effects of opioids, it is important to use a non-invasive way to effectively relieve pain including aromatherapy with analgesics.
This study is a clinical single-blind trial. The study was conducted on 40 patients who had open-heart surgery in the Cardiac ICU of two Hospitals of Tehran University of Medical Sciences, 2012. The level of patient’s pain before and after aromatherapy were analyzed by paired t-tests and chi-square and Fishers’ exact is used to investigate the relationship between demographic characteristics and pain. Statistical significance was accepted for P < 0.05.
Criteria included: full Consciousness, spontaneous breathing ability and not using synthetic opioids within 2 hours before extubation. Also, some exclusion criteria were set in this research. The patients that needed medical intervention during the inhalation, or in case of allergies, respiratory problems and emergencies, were excluded from this research.
After extubation, the patients were asked to mark the intensity of their pain using the visual analogue scale. Then, a cotton swab which was impregnated with 2 drops of Lavender essential oil 2% was placed in their oxygen mask, and they got breath for 10 minutes. Thirty minutes after aromatherapy, they were asked to re-mark their pain intensity. The level of patient’s pain before and after aromatherapy were compared.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013061813711N1
Registration date:2013-07-16, 1392/04/25
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-07-16, 1392/04/25
Registrant information
Name
Armaiti Salamati
Name of organization / entity
Islamic Azad University, Tehran Medical Branch
Country
Iran (Islamic Republic of)
Phone
+98 21 4490 1139
Email address
smashouf@iautmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Islamic Azad University Tehran Medical Branch
Expected recruitment start date
2012-11-21, 1391/09/01
Expected recruitment end date
2012-12-21, 1391/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of essential oil of Lavender inhalation on open-heart surgery pain
Public title
Effect of essential oil of Lavender inhalation on open-heart surgery pain
Purpose
Supportive
Inclusion/Exclusion criteria
Criteria included:
between 18 and 65
full Consciousness,
spontaneous breathing ability and
not using synthetic opioids within 2 hours before extubation.
Exclusion criteria:
needed medical intervention during the inhalation
in case of allergies,
respiratory problems and emergencies
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Islamic Azad University Tehran Medical Branch
Street address
Tehran
City
Tehran
Postal code
Approval date
2012-05-18, 1391/02/29
Ethics committee reference number
13610403902018
Health conditions studied
1
Description of health condition studied
open-heart surgery
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Pain
Timepoint
one hour after Lavender inhalation
Method of measurement
Pain measurement
Secondary outcomes
empty
Intervention groups
1
Description
A cotton swab which was impregnated with 2 drops of Lavender essential oil 2% was placed in their oxygen mask, and they got breath for 10 minutes
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Tehran Heart center
Full name of responsible person
Street address
City
Tehran
2
Recruitment center
Name of recruitment center
Moheb Hospital
Full name of responsible person
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research Departent of Islamic Azad University Tehran Medical Branch
Full name of responsible person
Naghipour (Research Dep of Azad University)
Street address
Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Departent of Islamic Azad University Tehran Medical Branch
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
Islamic Azad University
Full name of responsible person
Armaiti Salamati
Position
MS
Other areas of specialty/work
Street address
Tehran
City
Tehran
Postal code
Phone
+98 21 4490 1139
Fax
Email
arisalamati@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Armaiti Salamati
Position
MS
Other areas of specialty/work
Street address
Tehran
City
Tehran
Postal code
Phone
+98 21 4490 1139
Fax
Email
arisalamati@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University Tehran Medical Branch
Full name of responsible person
Armaiti Salamati
Position
MS in Nursing
Other areas of specialty/work
Street address
Tehran
City
Tehran
Postal code
Phone
+98 21 4490 1139
Fax
Email
arisalamati@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)