Determination the Effect of Inhalation aromatherapy with Essential Oil on Physiological Indices and Postoperative Complications of Appendectomy
Design
Clinical trials with placebo and control group,parallel, double blind, randomized clinical trials
Settings and conduct
research is conducted in Neyshabour University of Medical Sciences.In the test group, three drops of 1% aromatic geranium essential oil are manufactured by Barij Essence Company on a pad and patients are asked to inhale it for 5 minutes at a distance of 10 cm from the face at specified intervals and indicators of pain intensity, nausea, vomiting and physiological symptoms.In the placebo group, three drops of essential oil of sweet almonds, making the barium essential oil on a pad, and the same as the test group, are subjected to a medical treatment.There is no intervention in the control group and patients are treated with routine care. Examples and researcher assistance that measures the variables are unaware of the nature of the groups
Participants/Inclusion and exclusion criteria
Satisfied to participate in the study;Appendectomy is undergoing open procedure;Under general anesthesia;After surgery they are alert;The age of patients is between 15 and 45 years;Do not have drug addiction;Do not have a history of allergy ;There are no underlying illnesses;The duration of surgery should not exceed one hour;Do not have NGT
The occurrence of any unexpected complications during an intervention;Deny the patient from participating in the intervention
Intervention groups
Patients will assess the effect of aromatherapy with geranium essence.Patients will test the effect of the sweet almond essence on them.The control group There is no intervention on them and they are treated with routine treatments.
Main outcome variables
Physiological indices, pain, nausea and vomiting
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170131032329N2
Registration date:2018-09-26, 1397/07/04
Registration timing:registered_while_recruiting
Last update:2018-09-26, 1397/07/04
Update count:0
Registration date
2018-09-26, 1397/07/04
Registrant information
Name
Mahnaz Abavisani
Name of organization / entity
Gonabadl University Medical of Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 4222 5411
Email address
m.abavisani@gmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-09-23, 1397/07/01
Expected recruitment end date
2018-11-22, 1397/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of aromatherapy inhalation with geranium essence on physiological Parameter and post operative complications of appendectomy
Public title
The effect of aromatherapy inhalation with geranium essence on physiological Parameter and post operative complications of appendectomy
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
Satisfied to participate in the study
Appendectomy is undergoing open procedure
Under general anesthesia
After surgery, they are alert and have no known cognitive or psychological disorder
Patients with anesthesia risks 1 and 2
The age of patients is between 15 and 45 years
Do not consume drugs and not addicts
Do not have a history of allergies and allergies
There are no known underlying diseases
Duration of surgery should not exceed one hour
Do not have NG tube
Exclusion criteria:
The occurrence of any unexpected complications during an intervention that prevents further work with the patient, such as a severe reduce in blood pressure and other complications that may interfere with the patient's experience
Deny the patient from participating in the intervention
Age
From 15 years old to 45 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
In order to randomly assign individuals to the three groups and guaranteeing the balance of the number of people in groups, a random block method will be used.Sampling is done in several steps.In this study, the block size will be considered as six.Consequently, using randomized blocking, the participants randomly divided into three groups of aromatic herbal fragrances, aromatic herbs with a sweet almond and control group.
Blinding (investigator's opinion)
Double blinded
Blinding description
Research units, as well as researcher's help, which measure pain intensity, are unaware of the nature of the groups
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Neyshabur University of Medical Sciences
Street address
NO 489, North Asadabadi 17, North Arg Ave
City
Neyshabur
Province
Razavi Khorasan
Postal code
9315647483
Approval date
2018-09-08, 1397/06/17
Ethics committee reference number
IR.NUMS.REC.1397.18
Health conditions studied
1
Description of health condition studied
appendicitis
ICD-10 code
(K35-K38)
ICD-10 code description
(K00-K93)
Primary outcomes
1
Description
Pain score according to VAS scale
Timepoint
Measuring the intensity of pain when entering the operating room, when the patient enters recovery in the first time that the patient is able to respond, when leaving the recovery, 4 hours after surgery
Method of measurement
VAS Scale
2
Description
Vomiting Nausea Score based on the visual scale of the severity of nausea
Timepoint
Before entering the operating room, after entering the recovery, immediately after the second intervention, before leaving the recovery, 4 hours after the operation
Method of measurement
the visual scale of the severity of nausea
3
Description
Physiological Indices
Timepoint
Before entering the operating room, before induction of anesthesia, before the operation, after the completion of the operation, after entering the recovery, immediately after the second intervention, before leaving the recovery
Method of measurement
Using finger pulse oximeter and monitoring device
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In the aromatherapy group with geranium essence three grams of aromatic geranium essential oil of 1% maked by Barij Essence company are poured onto a pad and patients are asked to inhale it for 5 minutes at a distance of 10 cm from the face. At this time, the patient is prepared for anesthesia. Before induction of anesthesia, physiological symptoms are recorded before the operation is completed before the operation begins. When the patient enters a recovery, the patient is first responded with pain, nausea, vomiting and physiological symptoms. The patient is subjected to aromatherapy with geranium essence for a second time for 5 minutes, Immediately after the intervention and When the patient leaves the recovery (30 minutes after the patient's recovery) and 4 hours after the operation. Severity of pain, nausea, vomiting and physiological symptoms are recorded.
Category
Treatment - Other
2
Description
second intervention group: In the placebo group, during the delivery of the patient from the surgery ward to the operating room, a check list for pain intensity assessment according to the VAS scale, the visual scale of nausea and physiological indicators for the first time are completed and recorded.Patients with sweet almonds are inhaled.In the aromatherapy group with sweet almonds three drops of sweet almond essnce are made by Barij Essence company pured on a pad, and patients are asked to inhale it for 5 minutes at a distance of 10 cm from the face.At this time, the patient is prepared for anesthesia.Before induction of anesthesia, physiological symptoms are recorded before the operation is completed before the operation begins. When the patient enters recovery, the pain, nausea, vomiting and physiological symptoms are recorded at the first time that the patient is able to respond.The patient is subjected to a sweet almond oil for a second time for 5 minutes.Then immediately after the intervention and when the patient leaves the recovery(30 minutes after the patient enters the recovery)And 4 hours after the operation, the severity of pain, nausea, vomiting and physiological symptoms are recorded.
Category
Other
3
Description
Control group: In the control group, no intervention is performed and only the severity of the pain and vomiting and physiological indices in the mentioned stages are recorded and recorded, and patients are only treated with routine care.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
22 Bahman Hospital
Full name of responsible person
Mahnaz Abavisani
Street address
22 Bahman Hospital, Emam Khomeini Ave
City
Neyshabur
Province
Razavi Khorasan
Postal code
14139-93186
Phone
+98 51 4262 7501
Fax
+98 51 4262 7500
Email
mahnazabavisani@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Neyshabour University of Medical Sciences
Full name of responsible person
DrSeyd Reza Mirhafez
Street address
Neyshabur university of medical science, Razi Ave
City
Neyshabur
Province
Razavi Khorasan
Postal code
14139-93186
Phone
+98 51 4262 7501
Fax
+98 51 4262 7500
Email
m.abavisani@gmail.com
Web page address
https://www.nums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Neyshabour 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
2
Sponsor
Name of organization / entity
Neyshabour University of Medical Sciences
Full name of responsible person
Dr Seyd Reza Mirhafez
Street address
Neyshabur university of Medical Science, Razi Ave
City
Neyshabur
Province
Razavi Khorasan
Postal code
14139-93186
Phone
+98 51 4262 7501
Fax
+98 51 4262 7500
Email
m.abavisani@gmail.com
Web page address
https://www.nums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Neyshabour 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
Neyshabour University of Medical Sciences
Full name of responsible person
Mahnaz Abavisani
Position
Faculty of Nursing and Midwifery
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Neyshabur University of Medical Science, Razi Ave
City
Neyshabur
Province
Razavi Khorasan
Postal code
9315647483
Phone
+98 51 4222 5411
Email
mahnazabavisani@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Neyshabour University of Medical Sciences
Full name of responsible person
Mahnaz Abavisani
Position
Faculty of Nursing and Midwifery
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Neyshabur University of Medical Science, Razi Ave
City
Neyshabur
Province
Razavi Khorasan
Postal code
9315647483
Phone
+98 51 4222 5411
Email
Mahnazabavisani@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Neyshabour University of Medical Sciences
Full name of responsible person
Mahnaz Abavisani
Position
Faculty Nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Neyshabur University of Medical Science, Razi Ave
City
Neyshabur
Province
Razavi Khorasan
Postal code
9315647483
Phone
+98 51 4222 5411
Email
mahnazabavisani@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
No more information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available