Protocol summary

Study aim
Determining the effect of aromatherapy with Rosa damascena mill L. oil on severity of fatigue and physical discomfort of operating room nurses at Qom university of Medical Sciences hospitals
Design
Clinical trial with control group, with parallel groups, randomized, on 60 individuals. Blocking method is used for randomization.
Settings and conduct
Individuals are randomly allocated into intervention and control groups by random block method. In Intervention group, two drops of 40% Rosa damascena mill L. oil will be applied to cotton and individuals will be asked to attach it to their clothes or scarf at a distance of ten centimeters below the chin and inhale for 10 minutes. People in the control group will inhale two drops of placebo (normal saline) for 10 minutes. Completion of tools will be done before and immediately after aromatherapy. The study is conducted in the Kamkar-Arabnia, Nekoohi and Shahid Beheshti hospitals of Qom.
Participants/Inclusion and exclusion criteria
Inclusion conditions: tendency to participate in the study; Exclusion conditions: history of allergies and respiratory diseases, suffering from pulmonary diseases (asthma and obstructive lung diseases), sensitivity to herbal medicines, olfactory disorders, colds and nasal congestion, history of allergies and respiratory diseases, history of diseases such as rheumatism and multiple sclerosis.
Intervention groups
Individuals in the intervention group will inhale two drops of 40% rose essence for 10 minutes. People in the control group will inhale two drops of placebo (normal saline) for 10 minutes.
Main outcome variables
Severity of fatigue, Physical discomfort

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20140428017468N7
Registration date: 2023-07-22, 1402/04/31
Registration timing: prospective

Last update: 2023-07-22, 1402/04/31
Update count: 0
Registration date
2023-07-22, 1402/04/31
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
2023-08-23, 1402/06/01
Expected recruitment end date
2023-12-22, 1402/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of aromatherapy with Rosa damascena mill L. oil on severity of fatigue and physical discomfort of operating room nurses at Qom university of Medical Sciences hospitals
Public title
The effect of aromatherapy with Rosa damascena mill L. oil on severity of fatigue and physical discomfort
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Tendency to participate in the study No history of allergies and respiratory diseases No suffering from pulmonary diseases (asthma and obstructive lung diseases) Insensitivity to herbal medicines, Olfactory disorders, colds and nasal congestion No history of allergies and respiratory diseases No history of diseases such as rheumatism and multiple sclerosis
Exclusion criteria:
Using sleeping pills and painkillers
Age
No age limit
Gender
Both
Phase
3
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 intervention (A) and control (B) using blocking randomization method. In this method, 6 blocks of 4 are used (ABAB=1, BABA=2, ABBA=3, BAAB=4, AABB=5, BBAA=6). First, blocks of 4 are written on pieces of paper, and then the pieces of paper are placed in envelopes and numbered on the envelope to conceal random assignment. Then the choice of each envelope is randomly determined by throwing a dice based on the number of the dice.
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
Ethics Committee of Semnan University of Medical Sciences
Street address
Semnan University of Medical sciences, Basij Bolverd, Semnan, Iran
City
Semnan
Province
Semnan
Postal code
3514799442
Approval date
2023-06-26, 1402/04/05
Ethics committee reference number
IR.SEMUMS.REC.1402.075

Health conditions studied

1

Description of health condition studied
Fatigue
ICD-10 code
R53
ICD-10 code description
Malaise and fatigue

Primary outcomes

1

Description
Severity of fatigue
Timepoint
Before and immediately after intervention
Method of measurement
Brief Fatigue Inventory

2

Description
Physical discomfort
Timepoint
Before and immediately after intervention
Method of measurement
Patient Health Questionnaire-15

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: In this group, two drops of 40% Rosa damascena mill L. oil will be applied to cotton and individuals will be asked to attach it to their clothes or scarf at a distance of ten centimeters below the chin and inhale for 10 minutes.
Category
Treatment - Other

2

Description
Control group: In this group, two drops of normal saline will be applied to cotton and individuals will be asked to attach it to their clothes or scarf at a distance of ten centimeters below the chin and inhale for 10 minutes.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Kamkar-Arabnia Hospital
Full name of responsible person
Seyed Alireza Chavooshi Zade
Street address
Kamkar-Arabnia Hospital, Bajak road
City
Ghom
Province
Ghoum
Postal code
1497537138
Phone
+98 25 3771 3511
Email
Hosseini_amiri@yahoo.com

2

Recruitment center
Name of recruitment center
Nekoohi Hospital
Full name of responsible person
Javad Hakim Elahi
Street address
Ayatollah Taleghani St., Nekouei Hospital
City
Ghom
Province
Ghoum
Postal code
7335537158
Phone
+98 25 3721 1061
Email
Hosseini_amiri@yahoo.com

3

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

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Majid Mirmohammadkhani
Street address
Semnan university of medical sciences, Basij road, Semnan
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Email
Hosseini_amiri@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan University of Medical Sciences
Proportion provided by this source
10
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
Semnan University of Medical Sciences
Full name of responsible person
Meysam Hosseini Amiri
Position
Ph.D Candidate
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Semnan university of medical sciences, Basij road
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Email
Hoseini_amiri@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Meysam Hosseini Amiri
Position
Ph.D Candidate
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Semnan university of medical sciences, Basij Road
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Email
Hoseini_amiri@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Meysam Hosseini Amiri
Position
Ph.D Candidate
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Semnan university of medical sciences, Basij Road
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
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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