Determining the effect of aromatherapy with Geranium essential oil on fatigue and sleep quality of nurses working in the intensive care unit
Design
Clinical trial with control group, 84 intensive care unit nurses, double-blind, stratified random block
Settings and conduct
A double-blind clinical trial with a control group on 84 male and female nurses in the intensive care unit of Lorestan Medical Sciences-affiliated teaching hospitals. By easy and consecutive sampling method, participants will be randomly assigned in equal numbers to the intervention and control groups. The intervention group of pure geranium essential oil and control of pure sunflower essential oil will be inhaled in 3 consecutive shifts (morning / evening) for 20 minutes with normal breathing.
Participants/Inclusion and exclusion criteria
Entry requirements :
Volunteering to participate in the study, having at least 2 years of work experience and 6 months of work experience in the special unit, rotating shifts with night shifts, at least 3 night shifts in the monthly program, olfactory health, earning a score of 3 or more on the Visual Fatigue Scale; Score 150 or more on the Osipow Job Stress Scale
No entry conditions:
Pregnancy, use of herbal products, allergy to herbal and aromatic products, history of allergic rhinitis and migraine and respiratory problems, use of sedatives and effective drugs on sleep, liver and kidney problems, inflammatory and immune diseases
Intervention groups
The nurses of the intervention group poured a drop of pure geranium essential oil on an absorbable patch in a personal protective mask and the fragrance will be inhaled for 20 minutes in 3 consecutive work shifts (morning / evening) with normal breathing and twice in each shift. The control group will also receive a drop of pure sunflower essential oil in a completely similar way to the intervention group.
Main outcome variables
Fatigue
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20100609004129N5
Registration date:2021-01-29, 1399/11/10
Registration timing:registered_while_recruiting
Last update:2021-01-29, 1399/11/10
Update count:0
Registration date
2021-01-29, 1399/11/10
Registrant information
Name
Shirin Hasanvand
Name of organization / entity
Lorestan University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 66 1321 3759
Email address
hasanvand.sh@lums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-12-21, 1399/10/01
Expected recruitment end date
2021-05-20, 1400/02/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of aromatherapy with Geranium essential oil on fatigue and sleep quality of nurses working in the intensive care unit
Public title
The effect of aromatherapy on fatigue and sleep quality of nurses working in the intensive care unit
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Volunteer to participate in the study
Have at least 2 years of work experience and 6 months of work experience in the intensive care unit
Rotating shift with night shift
Have at least 3 night shifts in the monthly schedule
Olfactory health
score 3 or higher on the Visual Analogue Scale Fatigue
Score 150 or more on the Osipow Job Stress Scale
Exclusion criteria:
Pregnancy
Use of herbal products, herbal teas
Sensitivity to herbal and aromatic products
History of allergic rhinitis, respiratory allergies, respiratory problems and migraines
Use of sedatives and analgesics (steroids, non-steroids), benzodiazepines and sleeping pills
History of liver and kidney problems
Inflammatory and autoimmune diseases
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
84
Randomization (investigator's opinion)
Randomized
Randomization description
Considering the two classes of sex (male and female) and body mass index (lean-normal [(<25.5-18) and overweight-obesity (25-30), a total of 4 classes are formed. The method of 4 random blocks is used to assign nurses to two groups A (geranium fragrance intervention) and group B (placebo). To do this, first a list of blocks is written and numbers are assigned to them (AABB (1) - ABAB (2) -ABBA (3) -BBAA (4) - BABA (5) - BAAB (6)) Then select the numbers between one to 6 (for example 1 4 5 and ...) using a random number table. Finally, the allocation list will be based on a sequence of letters A and B.
Blinding (investigator's opinion)
Double blinded
Blinding description
All bottles containing essential oils will be identical in appearance and the pharmacist will assign a specific and random number on each bottle and the pharmacist will be unaware of the allocation of each essential oil to the experimental or control group. Also, the type of aroma and assignment of participants to the intervention and control group for the researcher and data analyst will not be known.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Lorestan University of Medical Sciences
Street address
Lorestan University of Medical Sciences, 4 km of Khorramabad-Borujerd road, Kamalvand, Khorramabad, Lorestan, Iran
City
Khorramabad
Province
Lorestan
Postal code
6813833946
Approval date
2020-10-11, 1399/07/20
Ethics committee reference number
IR.LUMS.REC.1399.194
Health conditions studied
1
Description of health condition studied
Intensive care unit nurses
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Fatigue
Timepoint
Immediately and 60 minutes after the intervention
Method of measurement
Visual Analogue Scale fatigue
Secondary outcomes
1
Description
sleep quality
Timepoint
The beginning of the first, second, third work shifts
Method of measurement
Verran and Snyder- Halpern sleep scale
Intervention groups
1
Description
Intervention group: Intervention group: In the intervention group, a drop of pure geranium essential oil was poured by the research colleague on an absorbable patch attached to the nurses' personal protective mask and they were asked to inhale the fragrance for 20 minutes by normal breathing. Aromatherapy in 3 consecutive work shifts (morning / evening) and each work shift twice and at certain times (9-10 and 11-12 in the morning shift and 15-16 and 17-17 in the evening shift) will be done.
Category
Other
2
Description
Control group: In the control group, a drop of pure sunflower essential oil was poured on an absorbable patch attached to the nurses' personal protective mask by the research colleague and they were asked to inhale the fragrance for 20 minutes by normal breathing. Aromatherapy in 3 consecutive work shifts (morning / evening) and each work shift twice and at certain times (9-10 and 11-12 in the morning shift and 15-16 and 17-17 in the evening shift) will be done.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Teaching hospitals affiliated to Lorestan University of Medical Sciences
Full name of responsible person
Dr. Shirin Hasanvand
Street address
Lorestan University of Medical Sciences, 4 km of Khorramabad-Borujerd road, Kamalvand, Khorramabad, Lorestan, Iran
City
Khorramabad
Province
Lorestan
Postal code
6814993165
Phone
+98 66 3312 0138
Email
Hasanvand.sh1390@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Khoram-Abad University of Medical Sciences
Full name of responsible person
Dr. Ebrahim Falahi
Street address
Lorestan University of Medical Sciences, Shahid Anoushirvan Rezaei Sq., Moallem St., Khorramabad, Lorestan, Iran
City
Khorramabad
Province
Lorestan
Postal code
6813833946
Phone
+98 66 3330 0661
Email
falahi.e@lums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Khoram-Abad 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
Khoram-Abad University of Medical Sciences
Full name of responsible person
Dِr. Shirin Hasanvand
Position
Doctor of Nursing, Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Lorestan University of Medical Sciences, 4 km of Khorramabad-Borujerd road, Kamalvand, Khorramabad, Lorestan, Iran
City
Khorramabad
Province
Lorestan
Postal code
6814993165
Phone
0098 66 120138
Email
Hasanvand.sh1390@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Khoram-Abad University of Medical Sciences
Full name of responsible person
Dr. Shirin Hasanvand
Position
Doctor of Nursing, Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Lorestan University of Medical Sciences, 4 km of Khorramabad-Borujerd road, Kamalvand, Khorramabad, Lorestan, Iran
City
Khorramabad
Province
Lorestan
Postal code
6814993165
Phone
+98 66 3312 0138
Email
Hasanvand.sh@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Khoram-Abad University of Medical Sciences
Full name of responsible person
Dr. shirin Hasanvand
Position
Doctor of Nursing, Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Lorestan Khorramabad, km 4 of Khorramabad-Borujerd road, Lorestan Medical Sciences Campus
City
Khorramabad
Province
Lorestan
Postal code
6814993165
Phone
+98 66 3312 0138
Email
Hasanvand.sh1390@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