Determining the effect of aromatherapy with Lemongrass in reducing the anxiety of patients undergoing scaling and root planing (SRP)
Design
randomized, unblinded, controlled clinical trial with parallel group design of 40 patients, PASS 2021 software was used for randomization.
Settings and conduct
40 eligible patients from Yazd Dental Faculty will be divided into two groups using stratified randomization. During SRP, the intervention group will receive aromatherapy with lemongrass essential oil, while the control group will receive distilled water. Before and after aromatherapy, the patients' subjective and objective anxiety will be measured using the state scale of Spielberger’s State-Trait Anxiety Inventory and physiological indicators (blood pressure, heart rate, blood oxygen), respectively. The level of perceived pain during treatment and treatment satisfaction will also be assessed after aromatherapy.
Participants/Inclusion and exclusion criteria
Entry criteria: Age between 25 and 50 years; having periodontitis stage II to IV and grade A or B
Non-entry criteria: History of SRP; systemic conditions such as high blood pressure, diabetes and lung problems; smoking; history of allergy to certain medicinal plants; having problems such as nasal congestion; loss of sense of smell due to Covid-19, etc; being diagnosed with sinusitis; being diagnosed with anxiety disorders; pregnancy; breastfeeding; receiving chemotherapy; taking pain relievers; taking anti-anxiety medications; taking medications that affect heart rate and blood pressure; taking antiseizure medications; taking immunosuppressive medications
Intervention groups
Intervention group: This group will receive aromatherapy with lemongrass essential oil during SRP treatment
Control group: For this group, during SRP treatment, distilled water will be used instead of lemongrass essential oil
Main outcome variables
The level of anxiety
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230615058492N2
Registration date:2024-02-21, 1402/12/02
Registration timing:prospective
Last update:2024-02-21, 1402/12/02
Update count:0
Registration date
2024-02-21, 1402/12/02
Registrant information
Name
Fahimeh Rashidimeibodi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3625 5881
Email address
f_rashidi63@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-04-03, 1403/01/15
Expected recruitment end date
2024-07-05, 1403/04/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the effect of Lemongrass aromatherapy on reducing the anxiety of patients undergoing scaling and root planing
Public title
Effect of Lemongrass aromatherapy on reducing anxiety
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 25 and 50 years
Having periodontitis stage II to IV and grade A or B
Exclusion criteria:
History of scaling and root planing
Having systemic conditions such as high blood pressure, diabetes or lung problems
Smoking
History of allergy to certain medicinal plants
Having allergies or problems such as nasal congestion
Loss of sense of smell due to Covid-19, etc
Being diagnosed with sinusitis
Being diagnosed with anxiety disorders
The patient is pregnant
The patient is breastfeeding
The patient is receiving chemotherapy
Taking pain relievers
Taking anti-anxiety medications
Taking medications that affect heart rate and blood pressure, such as diuretics and beta blockers
Taking antiseizure medications
Taking immunosuppressive medications
Age
From 25 years old to 50 years old
Gender
Both
Phase
4
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization is done in the form of simple stratified randomization . The strata include age variable in two groups (aged 25-37 and aged 38-50) and gender in two groups, and in total, random allocation is done in 4 separate layers, 10 samples considered in each layer. First, the age and gender are determined and the eligible individual is entered into the study in one of the 4 layers based on the random allocation table. Using PASS 2021 software, we will generate a random sequence using a simple random allocation method. The output of the software in the form of an Excel file includes the sequence from 1 to 40, the strata and unique codes for the research units. After determining the stratum based on age and gender for the eligible individuals, a number from 1 to 10 is considered for each person; and the person is assigned to an intervention group (A or B). The first eligible patient is assigned number 1, the second is assigned number 2, and so on, up to 10 patients in each stratum, and this is repeated for all the 4 strata.
Allocation concealment: In order to blindly assign the patients randomly, we will ask for the help of a third person who is unaware of the interventions and this table is given to them. When a patient eligible for the study visits, based on the patient's code, the intervention group will be asked from the third person over the phone and the patient will be assigned to one of the groups.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Blinding in this study will not be possible due to the presence of smellable aroma in the intervention group and its absence in the control group; Because the clinical caregivers and participants will distinguish the scent distinctly from distilled water anyway. However, the data analyst is blinded and has no knowledge of the case and control groups.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Faculty of Dentistry_ Shahid Sadoughi University of Medical Sciences, Yazd
Street address
Faculty of Dentistry, the beginning of Imam Reza Blvd, Imam Reza Square
City
Yazd
Province
Yazd
Postal code
8914881167
Approval date
2023-12-11, 1402/09/20
Ethics committee reference number
IR.SSU.DENTISTRY.REC.1402.044
Health conditions studied
1
Description of health condition studied
Anxiety
ICD-10 code
F41.9
ICD-10 code description
Anxiety disorder, unspecified
2
Description of health condition studied
Perceived pain during treatment
ICD-10 code
R52
ICD-10 code description
Pain, unspecified
Primary outcomes
1
Description
Anxiety score
Timepoint
Before the beginning of scaling and after scaling for two thirds of the teeth
Method of measurement
Spielberger’s State-Trait Anxiety Inventory–State Scale (containing 20 questions and scoring from 20 to 80)
Secondary outcomes
1
Description
Systolic blood pressure
Timepoint
Before the beginning of scaling and after scaling for two thirds of the teeth
Method of measurement
Digital sphygmomanometer model Ri-champion N from Riester® (measurement unit: millimeters Hg)
2
Description
Diastolic blood pressure
Timepoint
Before the beginning of scaling and after scaling for two thirds of the teeth
Method of measurement
Digital sphygmomanometer model Ri-champion N from Riester® (measurement unit: millimeters Hg)
3
Description
Pulse rate
Timepoint
Before the beginning of scaling and after scaling for two thirds of the teeth
Method of measurement
P-01 pulse oximeter device
4
Description
Arterial blood oxygen saturation percentage
Timepoint
Before the beginning of scaling and after scaling for two thirds of the teeth
Method of measurement
P-01 pulse oximeter device
5
Description
Pain grade on Visual Analogue Scale
Timepoint
After scaling for two thirds of the teeth
Method of measurement
Visual Analogue scale
6
Description
Patient satisfaction
Timepoint
After scaling for two thirds of the teeth
Method of measurement
Graded scale from 1 to 5 (1=dissatisfied/ 5=completely satisfied)
Intervention groups
1
Description
Intervention group: For this group, 3 drops (0.15 ml) of lemongrass essential oil (100% pure, non-edible) from Naringol brand (Tehran, Iran), which is originally a product of Moksha company (New Delhi, India) diluted in 100 ml of distilled water (according to the manufacturer's instructions), is poured onto sterile cotton/gauze and then rubbed around the patient's nostrils. Aromatherapy will continue from the beginning to the end of scaling and root planing treatment (for 25 to 35 minutes).
Category
Treatment - Drugs
2
Description
Control group: For this group, distilled water will be used for moistening the cotton/gas and rubbing around nostrils
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Sadoughi Faculty of Dentistry, Yazd
Full name of responsible person
Fahimeh Rashidi Maybodi
Street address
Faculty of Dentistry, the beginning of Imam Reza Blvd, Imam Reza Square
City
Yazd
Province
Yazd
Postal code
8914881167
Phone
+98 35 3625 5881
Email
f_rashidi63@ssu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
ّّّFahimeh Rashidi Maybodi
Street address
Faculty of Dentistry, the beginning of Imam Reza Blvd, Imam Reza Square
City
Yazd
Province
Yazd
Postal code
8914881167
Phone
+98 912 519 6227
Email
f_rashidi63@ssu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd 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
Yazd University of Medical Sciences
Full name of responsible person
Mahta Sadat Vaezpour
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Faculty of Dentistry, the beginning of Imam Reza Blvd, Imam Reza Square
City
Yazd
Province
Yazd
Postal code
8914881167
Phone
+98 35 3625 5881
Email
vmahtasadat@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Fahimeh Rashidi Maybodi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Faculty of Dentistry, the beginning of Imam Reza Blvd, Imam Reza Square
City
Yazd
Province
Yazd
Postal code
8914881167
Phone
+98 35 3625 5881
Email
f_rashidi63@ssu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Mahta Sadat Vaezpour
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Faculty of Dentistry, the beginning of Imam Reza Blvd, Imam Reza Square
City
Yazd
Province
Yazd
Postal code
8914881167
Phone
+98 35 3625 5881
Email
vmahtasadat@gmail.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