Aromatherapy study on anxiety and physiological indexes
Design
343 patients undergoing endoscopy with an entry criteria are selected. Patients were randomly assigned to three control groups and two interventions using random numbers. To hide groups, a code is assigned to each group.
Settings and conduct
Amir Al-Momenin Hospital, Blind double-sided
Participants/Inclusion and exclusion criteria
Inclusion criteria 1. Age 18 years old 2. Have a healthy sense of smell 3.No history of smoking 4. Not a history of allergy and allergy to medicinal herbs 5. No history of asthma or respiratory diseases 6. Alertness and ability to speaking 7. Reading and writing literacy, ability to understand Persian language 8. No history of new crisis over the past six months 9. Do not history of previous surgery Non-compliance criteria: 1. Use of other complementary and alternative methods during the study 2. Use hypnotic and antipyretic drugs, antidepressants and anti-anxiety during the study
Intervention groups
In intervention group number 1: one hour before endoscopy, after completing the demographic and Spielberger questionnaires and determining the mood by qualified individuals, physiological parameters including systolic and diastolic blood pressure, heart rate and respiratory rate were recorded by the researcher. After completing the basic information, in the aromatherapy intervention group with lavender essential oil, cotton balls impregnated with 2 to 3 drops of lavender essential oil are placed at a distance of 15 to 20 cm from the nose of the patient, and the mean After 5 to 10 minutes, the patient will be inhaled. In the intervention group number 2: the essential oil of orange will be used in this way, but from 2 to 3 drops of orange essential oil on cotton balls will be used. In the control group, distilled water will be used for aromatherapy.
Main outcome variables
anxiety, Physiological Indexes
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180103038211N6
Registration date:2019-01-27, 1397/11/07
Registration timing:prospective
Last update:2019-01-27, 1397/11/07
Update count:0
Registration date
2019-01-27, 1397/11/07
Registrant information
Name
Fahime Davodabady
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 3226 7610
Email address
F_davodabady@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-02-20, 1397/12/01
Expected recruitment end date
2019-06-20, 1398/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of aromatherapy on anxiety and physiological indexes before endoscopy
Public title
The effect of aromatherapy on anxiety
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All patients referring to the endoscopic unit
Have a healthy sense of smell
Be alert
Exclusion criteria:
History of smoking
History of allergy and allergy to medicinal herbs
A history of asthma or respiratory illness
The record of a new crisis, such as the death of a first-degree relative, a person or parent's divorce during the past six months
History of endoscopy in the past
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Sample size
Target sample size:
343
Randomization (investigator's opinion)
Randomized
Randomization description
The Subjects with entry criteria were selected by simple sampling methods and then were assigned with using random numbers randomly to either an experimental or a control group.
Blinding (investigator's opinion)
Double blinded
Blinding description
Individuals with entry criteria are divided into two intervention and control groups according to the random numbers table. Before and after the intervention, the information is collected by the evaluator of the outcome that is unaware of the grouping of the groups. Data analysis is also done by someone who is unaware of the allocation of groups. Also, the participants in the study in both groups received similar interventions and were unaware of the allocation to the intervention and control groups. Essential oil storage containers are a shape and one color.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Arak University of Medical Sciences
Street address
Arak University of Medical Sciences, Basij Square, Sardasht
City
Arak
Province
Markazi
Postal code
6941-7-38481
Approval date
2019-01-20, 1397/10/30
Ethics committee reference number
IR.ARAKMU.REC
Health conditions studied
1
Description of health condition studied
Anxiety
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Level of anxiety
Timepoint
Measure one hour before endoscopy, 20 minutes after intervention
Method of measurement
Spielberger questionnaire
2
Description
blood pressure
Timepoint
Measure one hour before endoscopy, 20 minutes after intervention
Method of measurement
Mercury pressure gauge device
3
Description
Pulse
Timepoint
Measure one hour before endoscopy, 20 minutes after intervention
Method of measurement
Stopwatch
4
Description
Respiratory rate
Timepoint
Measure one hour before endoscopy, 20 minutes after intervention
Method of measurement
Stopwatch
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Aromatherapy will be done one hour before the endoscope. For aromatherapy, 2 to 3 drops of lavender essential oil are placed on a cotton ball and placed 15 to 20 cm from the nose for 5 to 10 minutes.
Category
Treatment - Other
2
Description
Intervention group: One hour before the endoscope, aromatherapy will be done. For aromatherapy, 2 to 3 drops of orange essential oil are placed on a cotton ball, placed 15 to 20 cm from the nose for 5 to 10 minutes.
Category
Treatment - Other
3
Description
Control group: Aromatherapy will be similar to the intervention groups, but water is used.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Amir Al-Momenin Hospital
Full name of responsible person
Fahimeh Davodabady
Street address
Arak University of Medical Sciences, Basij Square, Sardasht
City
Arak
Province
Markazi
Postal code
6941-7-38481
Phone
+98 86 3417 3505
Email
fahimedavodabady@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mohammad Arjomandzadegan
Street address
Arak University of Medical Sciences, Basij Square, Sardasht
City
Arak
Province
Markazi
Postal code
6941-7-38481
Phone
+98 86 3417 3505
Email
arjomandzadegan@arakmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Fahimeh Davodabady
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Arak University of Medical Sciences, Basij Square, Sardasht
City
Arak
Province
Markazi
Postal code
6941-7-38481
Phone
+98 86 3417 3505
Email
fahimedavodabady@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Fahimeh Davodabady
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Arak University of Medical Sciences, Basij Square, Sardasht
City
Arak
Province
Markazi
Postal code
6941-7-38481
Phone
+98 86 3417 3505
Email
Fahimedavodabady@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Fahimeh Davodabady
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Arak University of Medical Sciences, Basij Square, Sardasht
City
Arak
Province
Markazi
Postal code
6941-7-38481
Phone
+98 86 3417 3505
Email
Fahimedavodabady@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD