To examine the effect of inhalation aromatherapy with lavender essential oil on death anxiety and sleep quality in emergency department nurses
Design
This is a randomized, single-blind, controlled, parallel-group study to evaluate the effect of lavender aromatherapy versus paraffin on death anxiety
and sleep quality of nurses (N=64).
Settings and conduct
Sixty-four emergency nurses working at hospitals will be randomly assigned to either the experimental group or the control group. The outcome assessor will be blinded to the allocated intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Being willing to participate in the study; being a registered nurse; having a minimum of 6 months of work experience in emergency departments; having a mobile phone.
Exclusion criteria: Having a history of being allergic to lavender; having a history of being allergic to essential oils and perfumes; being pregnant and breastfeeding; taking sedatives and hypnotics; being addicted to drugs and alcohol; suffering from acute respiratory diseases, dyspnea, or chronic cough; using any form of aromatherapy with essential oils; simultaneously participating in other studies.
Intervention groups
The experimental and control groups will receive bottles containing the required amount of lavender oil and paraffin, respectively. For two weeks, the experimental group will drip 2 drops of lavender oil on a cotton ball every night before going to sleep, take 2-3 deep breaths, and then attach the cotton ball to the collar of their clothes at a distance of 10 cm from their nose. The control group will also drip 2 drops of paraffin on a cotton ball every night for two weeks before going to sleep, take 2-3 deep breaths, and then attach the cotton ball to the collar of their clothes at a distance of 10 cm from their nose.
Main outcome variables
Death anxiety
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210523051370N8
Registration date:2023-02-12, 1401/11/23
Registration timing:prospective
Last update:2023-02-12, 1401/11/23
Update count:0
Registration date
2023-02-12, 1401/11/23
Registrant information
Name
Seyed Afshin Shorofi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3336 7342
Email address
ashorofi@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-02-14, 1401/11/25
Expected recruitment end date
2023-04-04, 1402/01/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Inhalation Aromatherapy with Lavender Essential Oil on Death Anxiety and Sleep Quality in Emergency Department Nurses
Public title
The Effect of Lavender Aromatherapy on Nurses' Death Anxiety and Sleep Quality
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Being willing to participate in the study
Being a registered nurse
Having a minimum of 6 months of work experience in emergency departments
Having a mobile phone
Exclusion criteria:
Having a history of being allergic to lavender
Having a history of being allergic to essential oils and perfumes
Being pregnant and breastfeeding
Taking sedatives and hypnotics
Being addicted to drugs and alcohol
Suffering from acute respiratory diseases, dyspnea, or chronic cough
Using any form of aromatherapy with essential oils
Simultaneously participating in other studies
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Investigator
Outcome assessor
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Randomized
Randomization description
Sixty-four nurses will be randomly assigned to either the experimental group or the control group. The randomization sequence will be computer generated with the permuted block technique and a 1:1 allocation ratio with allocations concealed in sealed, opaque, sequentially numbered envelopes.
Blinding (investigator's opinion)
Single blinded
Blinding description
The outcome assessor will be blinded to the allocated intervention. Nurses will be advised not to share it with the outcome assessor if they identify the intervention being received (lavender oil or paraffin). Glass bottles containing lavender oil and paraffin will be identical in size, color and shape, being prepared by a person not aware of the research objectives. The same person will deliver the bottles to the nurses of the two groups.
Placebo
Used
Assignment
Parallel
Other design features
The experimental group will receive dark colored bottles containing the required amount of lavender oil (Lavandula angustifolia) procured from the Barij Essence Pharmaceutical Company (Kashan, Iran) along with a dropper. The control group will also receive dark colored bottles containing the required amount of paraffin along with a dropper. For two weeks, the experimental group will drip 2 drops of lavender oil on a cotton ball every night before going to sleep, take 2-3 deep breaths, and then attach the cotton ball to the collar of their clothes at a distance of 10 cm from their nose. The control group will also drip 2 drops of paraffin on a cotton ball every night for two weeks before going to sleep, take 2-3 deep breaths, and then attach the cotton ball to the collar of their clothes at a distance of 10 cm from their nose.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Bioethics Committee of Mazandaran University of Medical Sciences
Street address
Moalem Square, Sari, Mazandaran Province
City
Sari
Province
Mazandaran
Postal code
4815733971
Approval date
2022-10-22, 1401/07/30
Ethics committee reference number
IR.MAZUMS.REC.1401.351
Health conditions studied
1
Description of health condition studied
Death Anxiety
ICD-10 code
F06.4
ICD-10 code description
Anxiety disorder due to known physiological condition
2
Description of health condition studied
Sleep quality
ICD-10 code
F51
ICD-10 code description
Sleep disorders not due to a substance or known physiological condition
Primary outcomes
1
Description
Death anxiety
Timepoint
T0 (before the intervention); Time 1 (end of the first week with aromatherapy); Time 2 (end of the second week with aromatherapy);- Follow-up (end of the third week)
Method of measurement
Death Anxiety Scale
Secondary outcomes
1
Description
Sleep quality
Timepoint
T0 (before the intervention); Time 1 (end of the first week with aromatherapy); Time 2 (end of the second week with aromatherapy); Follow-up (end of the third week)
Method of measurement
Pittsburgh Sleep Quality Index
Intervention groups
1
Description
Intervention group: The experimental group will receive bottles containing the required amount of lavender oil along with a dropper. For two weeks, they will drip 2 drops of lavender oil on a cotton ball every night before going to sleep, take 2-3 deep breaths, and then attach the cotton ball to the collar of their clothes at a distance of 10 cm from their nose.
Category
Other
2
Description
Control group: The control group will receive bottles containing the required amount of paraffin along with a dropper. For two weeks, they will drip 2 drops of paraffin on a cotton ball every night before going to sleep, take 2-3 deep breaths, and then attach the cotton ball to the collar of their clothes at a distance of 10 cm from their nose.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Fatemeh Zahra Hospital
Full name of responsible person
Dr. Seyed Afshin Shorofi
Street address
Fatemeh Zahra Hospital, Artesh Boulevard
City
Sari
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 3332 3023
Fax
Email
ashorofi@yahoo.com
2
Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Dr. Seyed Afshin Shorofi
Street address
Imam Khomeini Hospital, Amir Mazandarani Street
City
Sari
Province
Mazandaran
Postal code
33131 48166
Phone
+98 11 3337 7178
Fax
Email
ashorofi@yahoo.com
3
Recruitment center
Name of recruitment center
Zare Psychiatric and Burn Hospital
Full name of responsible person
Dr. Seyed Afshin Shorofi
Street address
Zare Psychiatric and Burn Hospital, Sari to Neka Road, Km 5
City
Sari
Province
Mazandaran
Postal code
4843185774
Phone
+98 11 3328 3889
Email
ashorofi@yahoo.com
4
Recruitment center
Name of recruitment center
Bu-Ali Sina Hospital
Full name of responsible person
Dr. Seyed Afshin Shorofi
Street address
Bu-Ali Sina Hospital, Pasdaran Boulevard
City
Sari
Province
Mazandaran
Postal code
4815838477
Phone
+98 11 3334 3014
Email
ashorofi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr Pedram Ebrahimnezhad
Street address
Moallem Square
City
Sari
Province
Mazandaran
Postal code
48115733971
Phone
+98 11 3325 7230
Email
pajoheshi@mazums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran 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
Mazandaran University of Medical Sciences
Full name of responsible person
Dr Seyed Afshin Shorofi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Complementary and Integrative Medicine
Street address
Mazandaran University of Medical Sciences
City
Sari
Province
Mazandaran
Postal code
4816715793
Phone
+98 911 676 6280
Email
ashorofi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr Seyed Afshin Shorofi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Complementary and Integrative Medicine
Street address
Mazandaran University of Medical Sciences
City
Sari
Province
Mazandaran
Postal code
4846715793
Phone
+98 11 3336 7342
Email
ashorofi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr Seyed Afshin Shorofi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Complementary and Integrative Medicine
Street address
Mazandaran University of Medical Sciences
City
Sari
Province
Mazandaran
Postal code
4816715793
Phone
+98 911 676 6280
Email
ashorofi@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD