To examine the effect of aromatherapy with lavender essential oil on well-being, severity of anxiety, depression and fatigue in patients undergoing hemodialysis
Design
This study is a single-blind randomized clinical trial with 120 hemodialysis patients allocated to three groups: control 1 (selected on even days), experimental (selected on even days) and control 2 (selective on odd days).
Settings and conduct
Shahrvand Dialysis Center
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age 18 years and older
Willingness to participate in the study
Dialysis treatment for at least 6 months
Performing dialysis three times a week
Ability to communicate
Absence of mental disorders
No experience of any stressful event in the last 6 months
Not using sedatives
No history of hospitalization due to psychological problems
No history of drug and alcohol addiction
Exclusion criteria:
Kidney transplant candidate
Pregnancy or decision to become pregnant
Breastfeeding
History of allergies to essential oils and perfumes
Acute respiratory disease
Intervention groups
In the experimental group, during the first hour of hemodialysis, a cotton ball impregnated with two drops of lavender essential oil at concentrations of 10% in the first week (3 sessions), 20% in the second week (3 sessions), 30% in the third week (3 sessions), 40% in the fourth week (3 sessions) and 50% in the fifth week (3 sessions) will be attached to the collar at a distance of 10 cm from the nose, and they are asked to breathe normally for 20 minutes.
In the control group, a cotton ball soaked in two drops of sweet almond oil is attached to the patient's collar at a distance of 10 cm from the nose. In this study, two control groups are considered.
Main outcome variables
Anxiety
Depression
Fatigue
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210523051370N5
Registration date:2021-12-20, 1400/09/29
Registration timing:prospective
Last update:2021-12-20, 1400/09/29
Update count:0
Registration date
2021-12-20, 1400/09/29
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
2021-12-22, 1400/10/01
Expected recruitment end date
2022-03-20, 1400/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of different doses of lavender on the psychological states and physical fatigue in dialysis patients
Public title
The effect of lavender on dialysis patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18 years and older
Willingness to participate in the study
Undergoing dialysis three times a week
Ability to communicate
Absence of mental disorders
No experience of any stressful event in the last 6 months (such as the death of a close relative)
Not using sedatives
No history of hospitalization due to psychological problems
No history of drug and alcohol addiction
Dialysis treatment for a minimum of 6 months
Exclusion criteria:
Kidney transplant candidates
Pregnancy or decision to become pregnant
Breastfeeding
History of allergies to essential oils and perfumes
Acute respiratory disease
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be selected based on systematic random sampling. Since about 140 patients are at the dialysis center every day, and the number of participants in each group is 40, the fixed periodic interval becomes 3 (140/40~3). Therefore, every third of the patients admitted to this center on Saturdays, Mondays, and Wednesdays are recruited into the experimental group, and the next one enters the control group-1. If any of these patients do not meet the inclusion criteria, the next one will be selected. If they do not meet the inclusion criteria, the previous one will be selected. Finally, 80 patients will be allocated to the experimental group and control group-1. Likewise, the number of patients referring to the center is 140 on Sundays, Tuesdays, and Thursdays. Since the number of required participants in the control group-2 is 40, every third patient will be selected.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, the assessor will be blinded to treatment allocation. To eliminate the effect of lavender fragrance on the assessor, a few drops of lavender essential oil will be splashed on the internal layer of their face mask.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Bioethics Committee of Mazandaran University of Medical Sciences
Street address
Vice Chancellor (Research), Mazandaran University of Medical Sciences, Moallem Square, Sari, Iran
City
Sari
Province
Mazandaran
Postal code
4815733971
Approval date
2020-03-25, 1399/01/06
Ethics committee reference number
IR.MAZUMS.REC.1399.035
Health conditions studied
1
Description of health condition studied
hemodialysis patients
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
anxiety and depression
Timepoint
Before the intervention and the end of the first, second, third, fourth and fifth weeks
Method of measurement
The Hospital Anxiety and Depression Scale
2
Description
Fatigue
Timepoint
Before the intervention and the end of the first, second, third, fourth and fifth weeks
Method of measurement
Fatigue Severity Scale
Secondary outcomes
1
Description
wellbeing
Timepoint
Before the intervention and the end of the first, second, third, fourth and fifth weeks
Method of measurement
Visual Analog Scale
Intervention groups
1
Description
Experimental group undergo inhalation of Lavender Angustifolia essential oil with herbarium number 1-133 procured from the Barij Essence Pharmaceutical Company (Kashan, Iran) and stored in semi-opaque UV-resistant glass bottles at room temperature. Lavender essential oil is inhaled on dialysis days for 5 weeks. A cotton ball soaked in two drops of lavender essential oil with concentrations of 10% in the first week (3 sessions), 20% in the second week (3 sessions), 30% in the third week (3 sessions), 40% in the fourth week (3 sessions) and 50% in the fifth week (3 sessions) will be attached to the collar at a distance of 10 cm from the patient's nose. Patient will be asked to breathe normally for 20 minutes. All patients will be in a semi-sitting position when inhaling lavender essential oil.
Category
Prevention
2
Description
Control group 1: a cotton ball soaked in two drops of sweet almond oil is attached to the patients' collars at a distance of 10 cm from the nose.
Category
Prevention
3
Description
Control group 2: a cotton ball soaked in two drops of sweet almond oil is attached to the patients' collars at a distance of 10 cm from the nose. The difference between the two control groups is the hemodialysis days. If these two control groups have outcomes that differ significantly, then this cannot reflect an effect of the treatment. The power of two control groups exceeds the probability of falsely detecting a treatment effect.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahrvand Dialysis Center, Sari, Iran
Full name of responsible person
Dr. Fatemeh Espahbodi
Street address
Shahrvand Dialysis Center, Keshavarz Boulevard, Sari, Iran
City
Sari
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 3329 1897
Email
ftespahbodi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Professor Majid Saeedi
Street address
Vice Chancellor for Research, Moallem Square, Sari, Iran
City
Sari
Province
Mazandaran
Postal code
48115733971
Phone
+98 11 3325 7230
Email
pajhooheshi@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
Nursery
Street address
Mazandaran University of Medical Sciences, Sari, Iran
City
Sari
Province
Mazandaran
Postal code
4816715793
Phone
+98 911 676 6280
Email
arabhoda1364@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr Seyed Afshin Shrofi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Mazandaran University of Medical Sciences, Sari, Iran
City
Sari
Province
Mazandaran
Postal code
۴۸۱۶۷۱۵۷۹۳
Phone
098 11 33367342
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, Mazandaran University of Medical Sciences, Sari, Iran
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Mazandaran University of Medical Sciences, Sari, Iran
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