Determining the effect of lavender and rosemary aroma on sleep quality of pre-hospital emergency personnel
Design
This randomized controlled clinical trial study with parallel and third phase groups will be performed on 150 patients and a random number table will be used for randomization.
Settings and conduct
Initially, based on the inclusion and exclusion criteria of sampling, after identifying the eligible samples, the samples will be randomly divided into three groups. In one group, the scent of lavender and in the other group, the scent of rose will be used. In the control group, distilled water will be given. The Pittsburgh Sleep Quality Questionnaire and demographic information checklist will be used to assess patients' sleep quality. Eligible patients will be included in the inclusion criteria.
Participants/Inclusion and exclusion criteria
Have at least one year of work experience
Have the health of the sense of smell
No underlying sleep-related illnesses (such as rheumatoid arthritis and migraines),
No known sleep disorders as reported by the patient (hospitalization, sleep-related medications)
No history of allergic asthma or rhinitis
No history of flower allergies, and Herbs and the smell of sweat and their essential oils
Not taking neuroleptic drugs
Not having vision problems and
Not having a care or treatment plan during sleep hours
lack of respiratory problems
Intervention groups
Intervention group 1 (aromatherapy with Lavender) and intervention group 2 (aromatherapy with Rosa-damascena)
Main outcome variables
Sleep quality score changes
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210809052128N1
Registration date:2022-06-21, 1401/03/31
Registration timing:prospective
Last update:2022-06-21, 1401/03/31
Update count:0
Registration date
2022-06-21, 1401/03/31
Registrant information
Name
Abas Jalali
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 87 3522 2649
Email address
abas1123.j@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-06-27, 1401/04/06
Expected recruitment end date
2022-07-28, 1401/05/06
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of lavender and Rosa-damascena on sleep quality of pre-hospital emergency staff
Public title
The effect of lavender and Rosa-damascena on sleep quality
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Have at least one year of work experience
Have the health of the sense of smell
No underlying sleep-related illnesses (such as rheumatoid arthritis and migraines),
No known sleep disorders as reported by the patient (hospitalization, sleep-related medications)
No history of allergic asthma or rhinitis
No history of flower allergies, and Herbs and the smell of sweat and their essential oils
Not taking neuroleptic drugs
Not having vision problems and
Not having a care or treatment plan during sleep hours
lack of respiratory problems
Exclusion criteria:
Arbitrary use of sedatives
Severe sensitivity to the scent of Rosa-damascena or lavender and
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
150
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be done using a table of random numbers. The numbers 0 to 49 will be considered for the first intervention group, 50 to 99 for the second intervention group, and 100 to 149 for the control group. The researcher will randomly put a hand on one of the numbers and move in one of the predetermined paths, then record the numbers and assign the individuals to the groups.
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
Ethic Committee of Kermanshah University of Medical Science
Street address
Kermanshah University of Medical Sciences, Shahid Beheshti Blvd.Kermashah,iran
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Approval date
2021-12-27, 1400/10/06
Ethics committee reference number
IR.KUMS.REC.1400.636
Health conditions studied
1
Description of health condition studied
Sleep disorders
ICD-10 code
G47
ICD-10 code description
Sleep disorders
Primary outcomes
1
Description
Sleep quality
Timepoint
Before intervention and four weeks after intervention
Method of measurement
Pittsburgh Sleep Quality Index
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In intervention group 1 (aromatherapy with Lavender), the method of intervention will be that the person pours two drops of the solution into the vial using a dropper on a cotton ball or paper towel and puts it at a distance of 15 to 20 cm from his nose. He takes a deep breath for two minutes and does this every other night for four weeks in the absence of shifts and at home. Due to the fact that this intervention is performed by the individual, the experimental group will give a vial of Lavender with a concentration of 2% (produced by Kashan Barij Essential Oil Company) to each of the samples.
Category
Other
2
Description
Intervention group: Intervention group: In intervention group 2 (aromatherapy with Rosa-damascena), the method of intervention will be that the person pours two drops of the solution into the vial using a dropper on a cotton ball or paper towel and puts it at a distance of 15 to 20 cm from his nose. He takes a deep breath for two minutes and does this every other night for four weeks in the absence of shifts and at home. Due to the fact that this intervention is performed by the individual, the experimental group will give a vial of Rosa-damascena with a concentration of 2% (produced by Kashan Barij Essential Oil Company) to each of the samples.
Category
Other
3
Description
Control group: In Control group (water), the method of intervention will be that the person pours two drops of the solution into the vial using a dropper on a cotton ball or paper towel and puts it at a distance of 15 to 20 cm from his nose. He takes a deep breath for two minutes and does this every other night for four weeks in the absence of shifts and at home. Due to the fact that this intervention is performed by the individual, the experimental group will give a vial of water to each of the samples.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Road and non-road emergency medical bases of Kermanshah province
Full name of responsible person
Abbas Jalali
Street address
Kermanshah University of Medical Sciences, Shahid Beheshti Blvd.Kermashah,iran
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3835 8943
Email
Abas1123.j@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Farid Najafi
Street address
Kermanshah university of Medical Science, Taleghani Street, Kermanshah,Iran
City
Kermanshah
Province
Kermanshah
Postal code
6715847167
Phone
+98 83 3837 0541
Email
fnajafi@kums.ac.ir
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
Tayebeh Mahvar
Position
PhD in Nursing
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Nursing Department, Kermanshah School of Nursing and Midwifery, Ashayer Blv. Kermanshah
City
Kermanshah
Province
Kermanshah
Postal code
00988338279394
Phone
+98 83 3835 8258
Email
mandanamahvar@ yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Tayebeh Mahvar
Position
PhD in Nursing
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Nursing Department, Kermanshah School of Nursing and Midwifery, Ashayer Blv. Kermanshah
City
Kermanshah
Province
Kermanshah
Postal code
00988338279394
Phone
+98 83 3835 8258
Email
mandanamahvar@ yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Tayebeh Mahvar
Position
PhD in Nursing
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Nursing Department, Kermanshah School of Nursing and Midwifery, Ashayer Blv. Kermanshah
City
Kermanshah
Province
Kermanshah
Postal code
00988338279394
Phone
+98 83 3835 8258
Email
mandanamahvar@ 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
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
Data on demographic information and patient pain are distributed as anonymous codes
When the data will become available and for how long
Starting data access is from 2022
To whom data/document is available
Access to data will be free for anyone interested in research
Under which criteria data/document could be used
Granting data for scientific use without fringe is allowed
From where data/document is obtainable
Can contact with a.noyani@shmu.ac.ir email
What processes are involved for a request to access data/document
About a month from the time of the first call through the email