Objective: The aim of this study is to evaluate of the effect of lavender extract on the severity of pain in patients with chronic otitist of the middle ear after surgery. Design: A randomized clinical trial. Setting: This study involved two groups of 50 patients undergoing chronic otitist surgery will be done. Each group consist of 25 patients people. Random allocation of samples will be done using block randomization.Intervention: Aromatherapy with lavender extract three consecutive days four times a day for patients after surgery will be done. The intervention is 4 drops of lavender essential oil for three minutes will inhale it. The control group consisted of routine nursing care is done by the staff.Before and after intervention to assess and compare pain intensity NSR scale is used. Inclusion criteria included: be conscious, lack of mental retardation, patient satisfaction in participating in the study. Exclusion criteria included: lack of patient cooperation during study.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016061825929N2
Registration date:2016-07-01, 1395/04/11
Registration timing:na
Last update:
Update count:0
Registration date
2016-07-01, 1395/04/11
Registrant information
Name
Mehdi Molavi Vardanjani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 81 3422 5056
Email address
m.molavi@umsha.ac.ir
Recruitment status
Not enough for processing
Funding source
Hamedan University of Medical Sciences
Expected recruitment start date
2016-06-21, 1395/04/01
Expected recruitment end date
empty
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of lavender extract on pain of patients after middle ear surgery.
Public title
The effect of lavender on pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: full consciousness; lack of mental retardation; patient satisfaction in participating in the study.
Exclusion criteria: lack of patient cooperation during the study.
Age
From 20 years old to 40 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
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
Hamedan University of Medical Sciences
Street address
Hamedan
City
Hamedan
Postal code
Approval date
2016-06-11, 1395/03/22
Ethics committee reference number
IR.UMSHA.REC.1395.122
Health conditions studied
1
Description of health condition studied
pain
ICD-10 code
H65.3
ICD-10 code description
Chronic mucoid otitis media
Primary outcomes
1
Description
pain
Timepoint
Before and after intervention
Method of measurement
NSRquestionnaire
Secondary outcomes
1
Description
Vital signs
Timepoint
before and after intervention
Method of measurement
questionnaire
Intervention groups
1
Description
The control group consisted of routine nursing care is done by the staff
Category
Other
2
Description
In the intervention group aromatherapy with lavender extract four times a day for three minutes on three consecutive days after ear surgery will be done.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Besat Hospital
Full name of responsible person
Mehdi Molavi Vardanjani
Street address
Hamedan
City
Hamedan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Hamedan University of Medical Sciences
Full name of responsible person
Mehdi Molavi Vardanjani
Street address
Hamedan
City
Hamedan
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 of Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Mehdi Molavi Vardanjani
Position
Master of Sciences
Other areas of specialty/work
Street address
Hamedan
City
Hamedan
Postal code
Phone
+98 81 3422 5650
Fax
Email
m.molavi@umsha.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Mehdi Molavi Vardanjani
Position
Master of Sciences
Other areas of specialty/work
Street address
Hamedan
City
Hamedan
Postal code
Phone
+98 81 3422 5650
Fax
Email
m.molavi@umsha.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Mehdi Molavi Vardanjani
Position
Master oh Science
Other areas of specialty/work
Street address
Hamedan
City
Hamedan
Postal code
Phone
00
Fax
Email
m.molavi@umsha.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)