Protocol summary

Study aim
Determining the effect of aromatherapy with Damascena oil on anxiety, accuracy and jab steress in operating room technologists in the hospitals of Qom university of medical sciences
Design
Randomized clinical trial
Settings and conduct
Subjects will allocate to two equal groups of control and intervention using block randomization method. Aromatherapy will last 10 minutes. Completion of tools will be done before and immediately after the aromatherapy. This study will done in the hospitals of Qom university of medical sciences.
Participants/Inclusion and exclusion criteria
Tendency to participate in the study, Having at least an associate degree in the operating room, Having at least 6 months of work experience in the operating room, Having a healthy sense of smell, No history of plant odor allergy, Absence of unfortunate event during the month before the study, Not taking sedatives, No history of chronic headaches including migraines and allergic diseases such as asthma.
Intervention groups
Subjects in intervention group will inhale 2 drops of Damascena oil 40% poured on upper lip during 10 minutes. Control group: Subjects in control group will inhale 2 drops of placebo (normal Saline) on upper lip during 10 minutes.
Main outcome variables
Anxiety related to COVID, Accuracy, Job Stress.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20140428017468N6
Registration date: 2021-11-13, 1400/08/22
Registration timing: registered_while_recruiting

Last update: 2021-11-13, 1400/08/22
Update count: 0
Registration date
2021-11-13, 1400/08/22
Registrant information
Name
Meysam Hoseini Amiri
Name of organization / entity
Faculty of Nursing and Midwifery, Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 35 1824 0936
Email address
hoseiniam911@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-11-09, 1400/08/18
Expected recruitment end date
2021-12-09, 1400/09/18
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of aromatherapy with Damascena oil on anxiety, accuracy and jab steress in operating room technologists
Public title
The effect of aromatherapy with Damascena oil on anxiety, accuracy and jab steress
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Tendency to participate in the study Having at least an associate degree in the operating room Having at least 6 months of work experience in the operating room Having a healthy sense of smell No history of plant odor allergy Absence of unfortunate event during the month before the study Not taking sedatives No history of chronic headaches including migraines and allergic diseases such as asthma
Exclusion criteria:
Unwillingness to continue collaborating in the study Using of perfumes and colognes
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Subjects will allocate to two equal groups of control and intervention using blocking randomization method. The blocking method will be used to balance the number of samples which assigned to each of the study groups. In this method, the blocks size will be selected randomly, so that an equal number of individuals of both groups there is in each block.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committee of Qom University of Medical Sciences
Street address
Vice chancellor for research of Qom University of Medical Sciences, Safashar road, Qom, Iran
City
Qom
Province
Ghoum
Postal code
3713649373
Approval date
2021-10-26, 1400/08/04
Ethics committee reference number
IR.MUQ.REC.1400.148

Health conditions studied

1

Description of health condition studied
Corona virus related anxiety
ICD-10 code
F06.4
ICD-10 code description
Anxiety disorder due to known physiological condition

Primary outcomes

1

Description
COVID-19 related anxiety
Timepoint
Before and immediately after intervention
Method of measurement
Spielberger questionnaire

2

Description
Accuracy
Timepoint
Before and immediately after intervention
Method of measurement
Bonardel Accuracy Test

3

Description
Job stress
Timepoint
Before and immediately after intervention
Method of measurement
Health and Safety Executive job stress questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Subjects will inhale 2 drops of Damascena oil 40% poured on upper lip during 10 minutes.
Category
Treatment - Drugs

2

Description
Control group: Subjects will inhale 2 drops of placebo (normal Saline) on upper lip during 10 minutes.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Qom Kamkar-Arabnia Hospital
Full name of responsible person
Javad Khodadad
Street address
Kamkar-Arabnia Hospital, Bjak road
City
Qom
Province
Ghoum
Postal code
1497537138
Phone
+98 25 3771 3511
Email
Hoseini_amiri@yahoo.com

2

Recruitment center
Name of recruitment center
Amiralmomenin Hospital
Full name of responsible person
Abas Ahmadi
Street address
Amiralmomenin Hospital, Shahid Beheshti road
City
Qom
Province
Ghoum
Postal code
6479737199
Phone
+98 25 3616 2854
Email
Hoseini_amiri@yahoo.com

3

Recruitment center
Name of recruitment center
Shahid Beheshti Hospital
Full name of responsible person
Yaser Frougi
Street address
Shahid Beheshti Hospital, Shahid Behashti road
City
Qom
Province
Ghoum
Postal code
6479737199
Phone
+98 25 3612 2000
Email
Hoseini_amiri@yahoo.com

4

Recruitment center
Name of recruitment center
بیمارستان نکویی
Full name of responsible person
جواد حکیم الهی
Street address
Ayatollah Taleghani St., Nekouei Hospital
City
Qom
Province
Ghoum
Postal code
7335537158
Phone
+98 25 3721 1061
Email
Hoseini_amiri@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Mohammad Reza Ghadir
Street address
Qom University of Medical Sciences, Saheli road
City
Qom
Province
Ghoum
Postal code
3713649373
Phone
+98 25 3107 1111
Email
Hoseini_amiri@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ghoum 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
Ghoum University of Medical Sciences
Full name of responsible person
Meysam Hosseini Amiri
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Qom University of Medical Sciences, Pardisan
City
Qom
Province
Ghoum
Postal code
3713649373
Phone
+98 25 3197 1088
Email
Hoseini_amiri@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Meysam Hosseini Amiri
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Pardisan, Qom university of medical sciences
City
Qom
Province
Ghoum
Postal code
3713649373
Phone
+98 25 3197 1088
Email
Hoseini_amiri@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Meysam Hosseini Amiri
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Pardisan, Qom University of Medical Sciences
City
Qom
Province
Ghoum
Postal code
3713649373
Phone
+98 25 3197 1088
Email
hoseini_amiri@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
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