The purpose of this study was to compare the effects of aromatherapy massage on anxiety and pain in burns patients and Aroma Inhalation are. Samples from female patients admitted to the burns ward of the Sinai city of Tabriz, their age is between 15 to 55 years, will be selected. Samples using a random number table into three groups, aromatherapy massage, aromatherapy inhaler and control will be divided. After the patient is stabilized and obtaining consent, for Anxiety Questionnaire STAI and for pain VAS pain scale before the intervention will be completed by the research assistant. Ten minutes after the intervention groups and 40 minutes after the initial review of control group, Anxiety Questionnaire STAI and VAS scale will be completed by the research assistant.The research assistant will be unware of the study groups and purpose of study. In aromatherapy massage group, the researchers used a combination of lavender and almond oils meet the unburned parts of the body will be massaged for 30 minutes. In aromatherapy inhaler group, Patient Combination of lavender and rose essential oils will inhaled for 30 minutes. Intervention in both groups will be done only once.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201404176918N17
Registration date:2014-06-01, 1393/03/11
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-06-01, 1393/03/11
Registrant information
Name
Alehe Seyedrasooli
Name of organization / entity
Faculty of Nursing & Midwifery
Country
Iran (Islamic Republic of)
Phone
+98 41 1479 0365
Email address
seyyedrasooly@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Science
Expected recruitment start date
2014-05-22, 1393/03/01
Expected recruitment end date
2014-10-23, 1393/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Comparison of Effects of Aromatherapy Massage and Aroma Inhalation on Anxiety and Pain of Burns Patients: A Single Blind Clinical Trial
Public title
The Comparison of Effects of Aromatherapy Massage and Aroma Inhalation on Anxiety and Pain of Burns Patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Female patients 15 to 55 years; 2nd degree burns and burn patients below 20 percent; Anxiety scores between 20-53 Exclusion Criteria: Anti-anxiety medications and herbal remedies; Having smells disorders; Having respiratory problems and allergies; exclusion of study; Pregnant Women
Age
From 15 years old to 55 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tabriz University of Medical Science
Street address
Central Building of Tabriz University of Medical Sciences,Golgasht Avenue, azadi street,Tabriz
City
Tabriz
Postal code
Approval date
2014-05-22, 1393/03/01
Ethics committee reference number
9290
Health conditions studied
1
Description of health condition studied
burn
ICD-10 code
T30.2
ICD-10 code description
Burn of second degree, body region unspecified
Primary outcomes
1
Description
Variable Anxiety
Timepoint
10 minutes before the intervention and Immediately after intervention
Method of measurement
By using STAI questionnaire
Secondary outcomes
1
Description
Variable Pain
Timepoint
10 minutes before the intervention and Immediately after intervention
Method of measurement
by using VAS scale
Intervention groups
1
Description
Control group: no action
Category
Prevention
2
Description
Aromatherapy massage intervention group: Massaging the healthy parts of the patient's body using a combination of lavender oil 3 drops and 15 ml almond oil for 30 minutes
Category
Prevention
3
Description
Intervention group aromatherapy inhaler: Smelling of lavender essential oil and Rose for30 min.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Sina Educational Center Affiliated Tabriz university of Medical Sciences ;Iran
Full name of responsible person
Seyyedi Zahra
Street address
Azadi Street, Tabriz
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Deputy of Tabriz University of Medical Sciences
Full name of responsible person
Dr. Rashidi
Street address
Central Building of Tabriz University of Medical Sciences,Golgasht Avenue, azadi street,Tabriz Tabriz
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy of Tabriz 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
Faculty of Nursing & Midwifery of Tabriz
Full name of responsible person
Seyedrasooli Alehe
Position
MS
Other areas of specialty/work
Street address
South Shariety St ، Faculty of Nursing & Midwifery ، Tabriz ; Iran
City
Tabriz
Postal code
Phone
+98 41 1479 0365
Fax
Email
seyyedrasooly@tbzmed.ac.ir
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)