Determination of the effect of lavender on the anxiety level of patients treated with electro convulsive therapy
Design
Clinical trials with control group, one blind, non-randomized
Settings and conduct
In this study, all adult patients admitted to Shahid Beheshti Hospital of Kerman, who will be treated with seizure therapy, will form the study population. Patients will be divided into two groups of control and intervention by randomization method.In the intervention group, half an hour before the seizure, two drops of lavender scent will be drawn on a non-absorbent polyethylene tissue and bonded with the patient's cloth with leukoplast, and then it will be asked to stand for twenty minutes as normal breathe. In the control group, only the usual measures will be used and the anxiety of the samples before and after the intervention will be compared by a blinded fellow researcher during three sessions with the Spielberger anxiety inventory .
Participants/Inclusion and exclusion criteria
Age of over 18 years, physical health, perceived and sensory ability (eyesight, hearing, olfactory) and lack of anxiety disorders, no use of essential oils and drugs for reducing anxiety since six weeks before the intervention. no suffering from other chronic diseases such as chronic obstructive pulmonary disease. not be a student or graduated in medical sciences or psychology.
Intervention groups
Intervention group: Aromatherapy with Lavender oil.
Control group: routine care in ward.
Main outcome variables
anxiety
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170516033997N4
Registration date:2018-12-18, 1397/09/27
Registration timing:registered_while_recruiting
Last update:2018-12-18, 1397/09/27
Update count:0
Registration date
2018-12-18, 1397/09/27
Registrant information
Name
Tahereh Ramezani
Name of organization / entity
Kerman University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 34331325220
Email address
t_ramezani@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-11-22, 1397/09/01
Expected recruitment end date
2019-01-21, 1397/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of aromatherapy with lavender on the anxiety of patients undergoing Electro Convulsive Therapy
Public title
Effect of aromatherapy with lavender on the anxiety
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients treated with Electro Convulsive Therapy(ECT)
Has awareness and insight into the disease
Perceptual and sensory ability
Exclusion criteria:
Sudden onset of any serious changes in vital signs
Allergy to Lavender essential oil
Patients in acute phase of psychosis
Patients who received less than 3 sessions of ECT
Age
From 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
Investigator
Sample size
Target sample size:
110
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Data collection is done by the researcher's colleague who does not know the group participants.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Kerman University of Medical Sciences
Street address
Somayeh Crossroads,Ethics Committee of Kerman University of Medical Sciences
City
Kerman
Province
Kerman
Postal code
7611239870
Approval date
2018-09-01, 1397/06/10
Ethics committee reference number
IR.KMU.REC.1397.193
Health conditions studied
1
Description of health condition studied
Anxiety
ICD-10 code
F06.4
ICD-10 code description
Anxiety disorder due to known physiological condition
Primary outcomes
1
Description
Anxiety is a common, unpleasant discomfort with anxiety that results in uncertainty, frustration and physiological anxiety
Timepoint
20 minutes after intervention 3 sessions a week
Method of measurement
Spielberger Anxiety Inventory
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: aromatherapy with lavenderoil 2% Which is from Kashan Barij Essen Co. Two drops of essential oil will be dropped on a napkin and patient will breathe for twenty minutes.
Category
Prevention
2
Description
Control group: In the control group, routine actions are performed before the ECT