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The effect of aromatherapy with the essential oil of citrus aurantium on anxiety, pain, blood pressure, heart rate, nausea & vomitting in patients subject to elective laparoscopic cholecystectomy

Protocol summary

Study aim
Determination of the effect of aromatherapy with the essential oil of citrus aurantium on anxiety, pain, blood pressure, nausea & vomitting in patients subject to elective laparoscopic cholecystectomy
Design
Patients were randomly divided into two groups of 40, intervention and control groups and were treated with essential oil of citrus aurantium in the intervention group and distilled water in control group from one hour before to 30 minutes after surgery. Finally, the results are compared in terms of anxiety, pain, blood pressure, heart rate, nausea and vomiting.
Settings and conduct
This study is performed on patients referred to Imam Reza Hospital of Kermanshah University of Medical Sciences. Blindness is performed for all patients and data collector and analyzer.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients aged 15-80 years, elective laparoscopic cholecystectomy surgery Exclusion criteria: Allergy to medicinal herbs, pulmonary allergy, age less than 15 years and over 80 years
Intervention groups
The smell of essential oil of citrus aurantium
Main outcome variables
anxiety; pain; blood pressure;heart rate; nausea ; vomitting

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190816044541N1
Registration date: 2019-09-13, 1398/06/22
Registration timing: registered_while_recruiting

Last update: 2019-09-13, 1398/06/22
Update count: 0
Registration date
2019-09-13, 1398/06/22
Registrant information
Name
Akram o sadat Ziaziabari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 83 3427 6301
Email address
akram.ziaziabari@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-07-06, 1398/04/15
Expected recruitment end date
2020-01-05, 1398/10/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of aromatherapy with the essential oil of citrus aurantium on anxiety, pain, blood pressure, heart rate, nausea & vomitting in patients subject to elective laparoscopic cholecystectomy
Public title
determination of the effect of aromatherapy with the essential oil of citrus aurantium on anxiety, pain, blood pressure, heart rate, nausea & vomitting in patients subject to elective laparoscopic cholecystectomy
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
patients age between 15-80 elective laparoscopic cholecystectomy surgery
Exclusion criteria:
Allergy to medicinal herbs Pulmonary allergy Age less than 15 years and more than 80 years
Age
From 15 years old to 80 years old
Gender
Both
Phase
4
Groups that have been masked
  • Participant
  • Care provider
  • Outcome assessor
  • Data analyser
  • Data and Safety Monitoring Board
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
Random number table
Blinding (investigator's opinion)
Triple blinded
Blinding description
All blind people only know that Participants are divided into two groups but they do not know the intervention type of each group.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of kermanshah University of Medical Sciences
Street address
kermanshah university of medical sciences, shahid beheshti Blvd
City
kermanshah
Province
Kermanshah
Postal code
6715847141
Approval date
2019-07-06, 1398/04/15
Ethics committee reference number
IR.KUMS..REC.1398.318

Health conditions studied

1

Description of health condition studied
anxiety, pain, blood pressure,heart rate, nausea & vomitting in laparoscopic cholecystectomy
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Anxiety score in Spiel Berger questionnaire
Timepoint
Hours before and 30 minutes after surgery
Method of measurement
Spiel Berger questionnaire

2

Description
Pain score based on visual analogue scale
Timepoint
Hours before and 30 minutes after surgery
Method of measurement
visual analogue scale

Secondary outcomes

1

Description
Reduce pain
Timepoint
30 minutes after surgery
Method of measurement
visual analogue scale

2

Description
Reduce anxiety
Timepoint
30 minutes after surgery
Method of measurement
Spiel Berger questionnaire

Intervention groups

1

Description
Control group:The smell of distilled water
Category
Placebo

2

Description
Intervention group: The smell of essential oil of citrus aurantium
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam reza hospital
Full name of responsible person
akram o sadat ziaziabari
Street address
Imam reza hospital, parastar Blvd
City
kermanshah
Province
Kermanshah
Postal code
6742775333
Phone
+98 83 3427 6307
Email
akram.ziaziabari@kums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
dr. farid najafi
Street address
kermanshah university of medical sciences, shahid beheshti Blvd
City
kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3838 4185
Email
farid_n32@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
akram o sadat ziaziabari
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Imam reza hospital, Parastar Blvd
City
kermanshah
Province
Kermanshah
Postal code
6742775333
Phone
+98 83 3427 6327
Email
akram.ziaziabari@kums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
javad aminisaman
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
imam reza hospital, Parastar Blvd
City
Kermanshah
Province
Kermanshah
Postal code
6742775333
Phone
+98 83 3427 6301
Fax
Email
aminisamanj99@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
akram o sadat ziaziabari
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Imam reza hospital, Parastar Blvd
City
kermanshah
Province
Kermanshah
Postal code
6742775333
Phone
+98 83 3427 6307
Email
akram.ziaziabari@kums.ac.ir

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
Confidentiality of patient information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
results will be shared after the anonymity of patients.
When the data will become available and for how long
the open access period is 6 months after publication of the results.
To whom data/document is available
all people
Under which criteria data/document could be used
For use by other researchers with the permission of the supervisor and approval of the research assistant
From where data/document is obtainable
by email: akram.ziaziabari@kums.ac.ir
What processes are involved for a request to access data/document
After acquiring the above, requested items will be sent.
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