The effect of aromatherapy on nausea, vomiting and anxiety
Design
All patients undergoing abdominal surgery are enrolled in this study. Then, patients with inclusion criteria were randomly assigned to two groups of control and intervention using a computer generated random number table. Each group is assigned a code to hide the groups.
Settings and conduct
Valiasr and Amir Al-Momenin hospital, double blind
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
3. Use of drugs that affect nausea and vomiting before starting the study
Intervention groups
In the intervention group aromatherapy with lime oil is performed in the department (3 times). In the control group, aromatherapy with water (as placebo) is performed (three times).
Main outcome variables
Nausea, vomiting, anxiety
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180103038211N9
Registration date:2019-08-01, 1398/05/10
Registration timing:registered_while_recruiting
Last update:2019-08-01, 1398/05/10
Update count:0
Registration date
2019-08-01, 1398/05/10
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
2019-06-22, 1398/04/01
Expected recruitment end date
2019-11-21, 1398/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of aromatherapy on anxiety, nausea and vomiting of patients undergoing abdominal surgery
Public title
Investigating the effect of aromatherapy in abdominal surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Abdominal Surgery
Have a healthy sense of smell
Exclusion criteria:
History of smoking
History of allergy and allergy to medicinal herbs
A history of asthma or respiratory illness
The history of a new crisis, such as the death of a first-degree relative, the divorce of a person or parent during the past six months
History of previous surgery
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:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Patients undergoing abdominal surgery are enrolled in the study. Then, a number is given to qualified patients, respectively, entering the study from 1 to n. Participants are randomly assigned to two groups of intervention and control by using a computer generated random number table.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants are divided into two groups of intervention and control. One of the groups is A and the other is called B. 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. Participants in the study received similar interventions and were unaware of the division of the groups and the type of substance used in the aromatherapy and the presence of the control group. Containers are a form and a color.
Placebo
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
2019-05-26, 1398/03/05
Ethics committee reference number
IR.ARAKMU.REC.1398.071
Health conditions studied
1
Description of health condition studied
Multiple sclerosis
ICD-10 code
G35
ICD-10 code description
Demyelinating diseases of the central nervous system
Primary outcomes
1
Description
Level of anxiety
Timepoint
Measure one hour before surgery, 20 minutes before surgery, one hour and two hours after full vigilance after surgery
Method of measurement
Anxiety Visual Analog Scale
2
Description
Nausea
Timepoint
one hour and two hours after full vigilance after surgery
Method of measurement
Visual Analog Scale Nausea
3
Description
Vomiting
Timepoint
one hour and two hours after full vigilance after surgery
Method of measurement
Measures based on occurrence or non-occurrence
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: One hour before surgery, after surgery, entering to the department, one hour after arrival to the department (three times), aromatherapy is done; for aromatherapy, 2-3 drops of lime oil on a cotton ball Shed and is placed 15 to 20 cm from the patient's nose for 5 to 10 minutes.
Category
Treatment - Other
2
Description
Control group: Aromatherapy with water (as placebo) is performed three times.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Valiasr and 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 3502
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 3502
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 3502
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 3502
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 3502
Email
fahimedavodabady@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available