The aim of this study is to investigate the effects of aromatherapy on level of anxiety in patients undergoing hand and upper extremity reconstructive surgery. This randomized clinical trial; single-center; placebo-controlled randomized controlled trial will be conducted on 100 patients in 15 Khordad therapeutic and educational center in Tehran. This study is single blind, as the participants are not aware of the type of the intervention. Participants randomly assigned to two intervention and control groups by the toss of a coin. Inclusion criteria: having age more than 18 years; earn a higher score of 20 after responding to a questionnaire STAI; ability to read and write; lack of mental illness. Exclusion criteria: acute pain at the time of completing the questionnaire; tranquilizers and drugs psychiatric drugs; allergic rhinitis and asthma; history of migraine and headache; lack of participation and the willingness of patients to withdraw from the study. The participants in the inhalation aromatherapy group inhaled tree drops of lavender essential oil who was dropped on a piece of cotton pad and those in the control group inhaled tree drops of distilled water as placebo for 20 min. Main outcomes included anxiety, blood pressure, Pulse rate and respiratory rate. The level of anxiety was evaluated by Spielberg's State Anxiety questionnaire before and after intervention and the vital signs were documented as well. The scores will be calculate and compared together.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016060826136N1
Registration date:2016-08-22, 1395/06/01
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-08-22, 1395/06/01
Registrant information
Name
Elaheh Rouhi Rahim Begloo
Name of organization / entity
15 Khordad Hospital
Country
Iran (Islamic Republic of)
Phone
+98 21 8894 3434
Email address
e-ruhi@alumnus.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2016-06-21, 1395/04/01
Expected recruitment end date
2016-09-22, 1395/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of aromatherapy with essential oil of lavender on anxiety of patients undergoing hand and upper extremity reconstructive surgery
Public title
The effect of aromatherapy with essential oil of lavender on anxiety
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: having age more than 18 years; earn a higher score of 20 after responding to a questionnaire STAI (minimum score of 20 and higher than 20 can show the impact of the intervention); the ability to understand and speak Persian; ability to read and write; the absence of olfactory dysfunction; lack of mental illness. Exclusion criteria: acute pain at the time of completing the questionnaire; the use of benzodiazepines; tranquilizers and drugs psychiatric drugs; a history of eczema and allergies to plants, allergic rhinitis and asthma; history of migraine and headache; drug addiction (alcohol and cigarettes); lack of participation and the willingness of patients to withdraw from the study.
Age
From 18 years old to 80 years old
Gender
Male
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
100
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 Shahid Beheshti University of Medical Sciences
Street address
Near the Hospital Ayatollah Taleqani, Shahid Arabi Street, Yemen Street, Chamran Higway, Tehran, Iran
City
Tehran
Postal code
Approval date
2016-07-03, 1395/04/13
Ethics committee reference number
IR.SBMU.REC.1395.12
Health conditions studied
1
Description of health condition studied
Anxiety
ICD-10 code
F41.1
ICD-10 code description
Generalized anxiety disorder
Primary outcomes
1
Description
Anxiety Intensity
Timepoint
Preintervention and 25 min after intervention
Method of measurement
Spielberger State Anxiety Inventory
Secondary outcomes
1
Description
Blood Presure
Timepoint
Pre intervention and 25 min after intervention
Method of measurement
Mercury blood pressure devices (Richter)
2
Description
Palse
Timepoint
Pre intervention and 25 min after intervention
Method of measurement
According to minutes using the pulse oximetry finger
3
Description
Breathing
Timepoint
Pre intervention and 25 min after intervention
Method of measurement
According to minutes using the standard digital clock
Intervention groups
1
Description
20 minute inhalation with 3 drop lavandula oil in inhalation aromatherapy group.
Category
Prevention
2
Description
20 minute inhalation with 3 drop water injection in placebo group.