Investigating the effect of rose extract aromatherapy on anxiety and physiological indices of conscious patients admitted at intensive care units of Rafsanjan Ali Ibn Abitaleb hospital, 2018-2019
Determination the effect of rose extract aromatherapy on anxiety and physiological indices of conscious patients admitted at intensive care units of Rafsanjan Ali Ibn Abitaleb hospital, 2018
Design
Clinical trial with parallel control group, single blind, randomized
Settings and conduct
This study, which is a blind clinical trial, is carried out in the caregiver of Ali ibn Abi Talib Hospital in Rafsanjan. The sample size is 60 people who are selected by available method and then assigned to two intervention and control groups by the method of random sampling by minimization method. For the intervention group, three drops of 10% of the essential oil are poured into the grass, and 20 cm away from the nose, the patients are placed on their shirt and the patients inhale it for 20 minutes. In the control group, three drops of distilled water are deposited on the same gaseous gas and, as in the intervention group, are placed on their shirt at the same time. The intervention is performed three times a day for one day every 20 minutes. Before and after each intervention, physiological indicators are recorded. The anxiety questionnaire is completed before the study begins and then completed at the end of the intervention.
Participants/Inclusion and exclusion criteria
No history of allergy to spring floral aroma; age 60-20 years old; pass at least 24 hours after admission to the intensive care unit; being alert to the patient; no olfactory problems.
Intervention groups
Three drops of 10% of the essential oil are poured into the grass, and 20 cm away from the nose, the patients are placed on their shirt and patients are inhaled for 20 minutes. In the control group three drops of distilled water. Intervention three times a day.
Main outcome variables
Anxiety; physiological indices
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170122032111N3
Registration date:2018-12-30, 1397/10/09
Registration timing:registered_while_recruiting
Last update:2018-12-30, 1397/10/09
Update count:0
Registration date
2018-12-30, 1397/10/09
Registrant information
Name
Maryame Shahabi nejad
Name of organization / entity
Rafsanjan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 34 3425 5900
Email address
m_shahabi@rums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-12-30, 1397/10/09
Expected recruitment end date
2019-03-20, 1397/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of rose extract aromatherapy on anxiety and physiological indices of conscious patients admitted at intensive care units of Rafsanjan Ali Ibn Abitaleb hospital, 2018-2019
Public title
Investigating the effect of rose extract aromatherapy on anxiety and physiological indices of conscious patients admitted
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Inclination to participate in research
No history of allergy to spring floral aroma
Age of 60-20 years
Pass at least 24 hours after admission to the intensive care unit
Not having a previous history of admission to the intensive care unit
Patient's chewiness (four Score Above 12
Not having a ban on a physician for aesthetic remedy
No history of psychiatric illness
No History of the use of psychoneurology
Lack of olfactory problems
Lack of any underlying illness, such as epilepsy and skin disease
Exclusion criteria:
Allergy
Find out the odor problem after coffee smell testing
Use of other stress-reducing methods
Use Neurology and Neuron in the section
Age
From 20 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
The samples are selected according to the criteria of entry in the method and then assigned to the intervention and control groups by random sampling method by the method of minimization
Blinding (investigator's opinion)
Single blinded
Blinding description
Analyzer
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Rafsanjan University of Medical Sciences
Street address
Imam Ali Blvd, Rafsanjan University of Medical Sciences
City
Rafsanjan
Province
Kerman
Postal code
7717932777
Approval date
2018-06-27, 1397/04/06
Ethics committee reference number
IR.RUMS.REC.1397.069
Health conditions studied
1
Description of health condition studied
anxiety and physiological indices of conscious patients admitted at intensive care units
ICD-10 code
F41.9
ICD-10 code description
Anxiety disorder, unspecified
Primary outcomes
1
Description
Anxiety
Timepoint
Before the beginning of the study and at the end of the third turn
Method of measurement
Spielberger's apparent anxiety questionnaire
2
Description
physiological indices
Timepoint
Before and after each intervention
Method of measurement
Monitoring and observation device
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Three drops of 10% Rose Essential Oil, three times a day, 20 minutes each, inhalation, Golab Darin Kashan Company
Category
Other
2
Description
Control group: routin care
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Ali Ibn Abitaleb hospital
Full name of responsible person
Shahabi Nejad Maryam
Street address
Imam Ali Blvd, Rafsanjan University of Medical Sciences
City
Rafsanjan
Province
Kerman
Postal code
7717932777
Phone
+98 34 3425 5900
Email
M_SHAHABI@RUMS.AC.IR
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Shamsizadeh Ali
Street address
Imam Ali Blvd, Rafsanjan University of Medical Sciences
City
Rafsanjan
Province
Kerman
Postal code
7717932777
Phone
+98 34 3425 5900
Email
vcrt@rums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rafsanjan 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
Rafsanjan University of Medical Sciences
Full name of responsible person
Shahabi Nejad Maryam
Position
MSN
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Imam Ali Blvd, Rafsanjan University of Medical Sciences
City
Rafsanjan
Province
Kerman
Postal code
7717932777
Phone
+98 34 3425 5900
Fax
+98 34 2534 8497
Email
M_SHAHABI@rums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Shahabi Nejad Maryam
Position
MSN
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Imam Ali Blvd, Rafsanjan University of Medical Sciences
City
Rafsanjan
Province
Kerman
Postal code
7717932777
Phone
+98 34 3425 5900
Email
M-SHAHABI@RUMS.AC.IR
Person responsible for updating data
Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Shahabi Nejad Maryam
Position
MSN
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Imam Ali Blvd, Rafsanjan University of Medical Sciences
City
Rafsanjan
Province
Kerman
Postal code
7717932777
Phone
+98 34 3425 5900
Email
M_SHAHABI@RUMS.AC.IR
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
The total potential data can be shared after unidentifiable people
When the data will become available and for how long
Start the access period 6 months after printing the results
To whom data/document is available
Researchers working in academia and academia
Under which criteria data/document could be used
Research use
From where data/document is obtainable
M_Shahabi@rums.ac.ir
What processes are involved for a request to access data/document
Start the access period 6 months after printing the results