The Effect of Citrus Aurantium aroma on pain and physiological criteria of patients undergoing hand reconstructive surgery hospitalized in intensive care unit
Determining effect of Citrus Aurantium aroma on pain and physiological criteria
Design
A blinded quasi-experimental study with a control group. 76 patients with inclusion criteria were randomly assigned to Citrus Aurantium or placebo
Settings and conduct
Pain and physiological parameters are measured before the intervention.
In the operating room recovery, the researcher, without knowing the type of solution (Citrus Aurantium with a concentration of 40% or placebo), pour the solution on the pad 2 × 2 . Pad soaked in a solution of(Citrus aurantium or placebo) is taken at a distance of 5 cm from the nose up to ten breaths and then that pad is attached to the patient's collar. At the end of half an hour, the pain rating and physiological criteria are checked and recorded.
After transferring the patient from the recovery room to the intensive care unit while the pad is attached to the patient's collar, one hour after the second record, the pain rating and physiological criteria are checked again and is recorded.
Participants/Inclusion and exclusion criteria
Inclusion criteria: age over 18 years old ,after reconstructive hand surgery, the patient should be transferred to the intensive care unit,alertness and ability to understand and express pain, informed consent for research , , healthy sense of smell.
No entry :having allergies, drug addiction , uncontrolled diabetes and neuropathy, mental illness and cognitive disorders.
Intervention groups
Citrus Aurantium solution with a concentration of 40%, 0/4 ml
placebo solution 0/4 ml
Main outcome variables
pain ; Pulse; Breathing; blood pressure
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200811048374N1
Registration date:2021-03-01, 1399/12/11
Registration timing:retrospective
Last update:2021-03-01, 1399/12/11
Update count:0
Registration date
2021-03-01, 1399/12/11
Registrant information
Name
farideh askari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8889 3102
Email address
alaei@shahed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-08-22, 1399/06/01
Expected recruitment end date
2020-11-12, 1399/08/22
Actual recruitment start date
2020-08-22, 1399/06/01
Actual recruitment end date
2020-11-12, 1399/08/22
Trial completion date
2020-11-12, 1399/08/22
Scientific title
The Effect of Citrus Aurantium aroma on pain and physiological criteria of patients undergoing hand reconstructive surgery hospitalized in intensive care unit
Public title
Citrus Aurantium aroma on pain and physiological criteria
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patient undergoing reconstructive hand surgery who are is transferred to the intensive care unit after surgery
The patient is alert and awake and the ability to understand and express the pain and the patient is able to cooperate
Age range over 18 years based on the year of birth
Healthy sense of smell according to the patient
Exclusion criteria:
Drug addiction (according to the patient statement and the file)
Uncontrolled diabetes and neuropathy
Mental illness and cognitive disorders based on the records in patient's file
History of respiratory allergies, asthma, allergic rhinitis and allergies to plant products according to the patient
Age
From 18 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
76
Actual sample size reached:
76
Randomization (investigator's opinion)
Randomized
Randomization description
According to the required number of samples, a total of 76 patients were estimated، 38 patients in the experimental group and 38 patients in the control group. Randomization was performed by simple method with Excel software with 76 numbers in two groups and in each group 38 numbers were placed randomly.
Blinding (investigator's opinion)
Double blinded
Blinding description
there are glass containers in the similar package with the code ، containing equal amounts of placebo and Citrus Aurantium . The researcher without knowing the type of solution of each container, randomly selected one of the containers and used its solution for the research sample with inclusion criteria and then recorded the data.
The samples were not aware of the type of solution used.
Placebo
Used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shahed university
Street address
Persian Gulf High Way Shahed university
City
Tehran
Province
Tehran
Postal code
3319118651
Approval date
2020-04-28, 1399/02/09
Ethics committee reference number
IR.SHAHED.REC.1399.019
Health conditions studied
1
Description of health condition studied
Pain and physiologic criteria
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
pain
Timepoint
Before intervention . Half an hour after the intervention and one and a half hours after the intervention
Method of measurement
Visual analog scale for pain
2
Description
pulse - respiration- Blood Pressure ( systolic and diastolic)
Timepoint
Before intervention . Half an hour after the intervention and one and a half hours after the intervention
Method of measurement
records on monitor
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: After surgery in the recovery room, while the patient is is conscious , before performing the intervention, 1- pain and physiological parameters are measured. 2-The researcher, Citrus Aurantium solution pours on the pad 2 * 2(0.4 ml ),the pad is taken a distance of 5 cm from the nose up to ten breaths and then the pad was attached to the patient's collar, after half an hour, pain and physiological measurements are checked and recorded. 3-After transferring the patient from the recovery room to the intensive care unit while the pad is attached to the patient's collar, one hour after the second recording, the pain and physiological criteria are checked and recorded .
Category
Other
2
Description
Control group: After surgery in the recovery room, while the patient is is conscious , before performing the intervention, 1- pain and physiological parameters are measured. 2-The researcher,placebo solution pours on the pad 2 * 2(0.4 ml ), the pad is taken a distance of 5 cm from the nose up to ten breaths and then the pad was attached to the patient's collar, after half an hour, pain and physiological measurements are checked and recorded. 3-After transferring the patient from the recovery room to the intensive care unit while the pad is attached to the patient's collar, one hour after the second recording, the pain and physiological criteria are checked and recorded .
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Hazrat Fatemeh Hospital affiliated to Iran University of Medical Sciences
Full name of responsible person
Noorahmad Latifi
Street address
yosefabad
City
Tehran
Province
Tehran
Postal code
1433933111
Phone
+98 21 8871 7272
Email
Crtfatima@iums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahed University
Full name of responsible person
Zahra Kiasalari
Street address
Shahed University in front of Imam Khomeini Shrine Persian Gulf Highway
City
Tehran
Province
Tehran
Postal code
3319118651
Phone
+98 21 5121 5105
Email
kiasalari@shahed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahed University
Proportion provided by this source
50
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
Shahed University
Full name of responsible person
Nasrin Alaee
Position
Faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Shahed University in front of Imam Khomeini Shrine Persian Gulf Highway
City
Tehran
Province
Tehran
Postal code
3319116851
Phone
+98 21 5121 2130
Email
n_alaie@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahed University
Full name of responsible person
Nasrin Alaee
Position
faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Shahed university In front of the holy shrine of Imam Khomeini Persian Gulf Highway
City
Tehran
Province
Tehran
Postal code
3319118651
Phone
+98 21 5121 2130
Email
n_alaie@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shahed University
Full name of responsible person
Nasrin Alaee
Position
faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Shahed university In front of the holy shrine of Imam Khomeini Persian Gulf Highway
City
Tehran
Province
Tehran
Postal code
3319118651
Phone
+98 21 5121 2130
Email
n_alaie@yahoo.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
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available