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The effect of lavender aroma on occupational stress and sleep quality of pre-hospital emergency personnel

Protocol summary

Study aim
Determining the effect of lavender aroma on occupational stress and sleep quality of pre-hospital emergency personnel
Design
This study is a clinical trial with control group, with parallel groups, single blind,Randomized by coin toss, sample size is 70, 2–3 phase
Settings and conduct
Participants in this study will be Kerman pre-hospital emergency personnel. Intervention group will receive glass pendant neck containing 25% lavender essence and control group will receive glass pendant containing sweet almond oil. Intervention will be one month.Before, immediately and one month after the intervention, sleep quality and job stress questionnaires will be completed.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Age between 20 to 45 years, no anxiolytic and other relaxing herbal remedies , no drug addiction, no working in other health care facilities, normal olfactory test, no history of nasal surgery, no liver or kidney problems, work experience more than one year. Exclusion Criteria:Respiratory and allergic problems
Intervention groups
intervention group:25% lavender essencel will be provided by Tabib Darou Co., Kashan. Intervention group will inhale lavender essence.Intervention group will be presented with 5 cc glass neck pendants containing lavender essential oil.The pendants will be installed within 30 cm of the subjects nose.The pendants will be used for one month, 3 times a week and daily for two hours at the end of each shift.The researcher will remind the subjects during the intervention by telephone and text message. Finally, the questionnaires will be completed again immediately and 30 days after the intervention. control group:It will look exactly like the intervention group.in this group, the pendants contain refined and odorless sweet almond oil
Main outcome variables
Occupational stress, sleep quality

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190515043601N3
Registration date: 2020-02-01, 1398/11/12
Registration timing: retrospective

Last update: 2020-02-01, 1398/11/12
Update count: 0
Registration date
2020-02-01, 1398/11/12
Registrant information
Name
Hossein Rahimi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 56 3238 1427
Email address
hosseinrahimi92@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-01-21, 1397/11/01
Expected recruitment end date
2019-09-23, 1398/07/01
Actual recruitment start date
2019-01-21, 1397/11/01
Actual recruitment end date
2019-09-23, 1398/07/01
Trial completion date
2019-09-23, 1398/07/01
Scientific title
The effect of lavender aroma on occupational stress and sleep quality of pre-hospital emergency personnel
Public title
The effect of lavender aroma on occupational stress and sleep quality of pre-hospital emergency personnel
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Ages between 20 to 45 years Not use anxiolytic and other Relaxing herbal remedies non-drug addiction no Working in other health care facilities passing an olfactory test Having no history of nasal surgery not having liver or kidney problems work experience more than one year
Exclusion criteria:
Respiratory and allergic problems
Age
From 20 years old to 45 years old
Gender
Male
Phase
2-3
Groups that have been masked
  • Data analyser
Sample size
Target sample size: 70
Actual sample size reached: 70
Randomization (investigator's opinion)
Randomized
Randomization description
12 pre-hospital emergency bases will be randomly divided into intervention and control groups using the coin toss (only bases will be randomized when personnel will not be randomized).
Blinding (investigator's opinion)
Single blinded
Blinding description
The data analyst will be unaware of the type of intervention for each group
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Birjand University of Medical Sciences
Street address
Ayatollah Ghafari Blv
City
Birjand
Province
South Khorasan
Postal code
۹۷۱۷۸۵۳۵۷۷
Approval date
2019-02-05, 1397/11/16
Ethics committee reference number
IR.BUMS.REC.1397.352

Health conditions studied

1

Description of health condition studied
Sleep quality,Occupational stress
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
sleep quality
Timepoint
Before, immediately, one month after the end of the intervention
Method of measurement
Pittsburgh Sleep Quality Questionnaire

2

Description
Occupational stress
Timepoint
Before, immediately, one month after the end of the intervention
Method of measurement
Nursing stress scale

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: There will be 35 participants in the lavender group.Participants will receive a 5cc glass necklace containing 25% lavender essence. pendants will be used at the end of each shift for 2 hours, three times a week for one month.Questionnaires will be completed before, immediately and one month after the intervention.
Category
Treatment - Drugs

2

Description
Control group: There will be 35 participants in this group.Participants will receive a 5cc glass necklace containing refined Sweet almond oil without odor .pendants will be used at the end of each shift for 2 hours, three times a week for one month.Questionnaires will be completed before, immediately and one month after the intervention.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Kerman University of Medical Sciences,Pre-hospital emergency bases
Full name of responsible person
Seyyed Mohamad Saberi
Street address
Emergency Management Center, Campus of Medical Sciences University, Haft Bagh Alavi Blv
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 9000
Email
Ems@kmu.ac.ir
Web page address

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Tooba Kazemi
Street address
Birjand University of Medical Sciences, Ayatollah Ghaffari Blv
City
Birjand
Province
South Khorasan
Postal code
۹۷۱۷۸۵۳۵۷۷
Phone
+98 56 3238 1200
Email
drtooba.kazemi@ gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Birjand 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
Birjand University of Medical Sciences
Full name of responsible person
Hossein Rahimi
Position
Instructor
Latest degree
Master
Other areas of specialty/work
CAM
Street address
Ayattolah Ghafari Blv
City
Birjand
Province
South Khorasan
Postal code
۹۷۱۷۸۵۳۵۷
Phone
+98 56 3238 1424
Email
hosseinrahimi92@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Hossein Rahimi
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Ayattolah Ghafari Blv
City
Birjand
Province
South Khorasan
Postal code
۹۷۱۷۸۵۳۵۷
Phone
+98 56 3238 1400
Email
hosseinrahimi92@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Hossein Rahimi
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Ayattolah Ghafari Blv
City
Birjand
Province
South Khorasan
Postal code
۹۷۱۷۸۵۳۵۷
Phone
+98 56 3238 1400
Email
hosseinrahimi92@yahoo.com

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
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
All potential data can be shared after unidentifiable participants
When the data will become available and for how long
Start of access period 12 months after printing results
To whom data/document is available
It will only be available to researchers working in academic and scientific institutions
Under which criteria data/document could be used
In order to access the data, researchers can request access to the information 12 months after the results are published. Within two weeks, the information will be sent to them.It should be noted that applicants must be faculty members of the Ministry of Health.
From where data/document is obtainable
Applicants can apply to the Birjand University of Medical Sciences School of Nursing and Midwifery for information.
What processes are involved for a request to access data/document
After verifying the identity of the applicant, the data will be submitted to the researcher within 2 weeks.
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