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IRCT20230615058492N2 IRCT 2024-02-21 Yazd University of Medical Sciences Effect of Lemongrass aromatherapy on reducing anxiety Evaluating the effect of Lemongrass aromatherapy on reducing the anxiety of patients undergoing scaling and root planing 2024-04-03 anticipated 40 Complete https://irct.ir/trial/74902 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, 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, 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. 4 Condition 1: Anxiety. Condition 2: Perceived pain during treatment. Intervention 1: 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). Intervention 2: Control group: For this group, distilled water will be used for moistening the cotton/gas and rubbing around nostrils. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information
public Mahta Sadat Vaezpour
Faculty of Dentistry, the beginning of Imam Reza Blvd, Imam Reza Square
Yazd Iran (Islamic Republic of) 8914881167 +98 35 3625 5881 vmahtasadat@gmail.com Yazd University of Medical Sciences scientific Fahimeh Rashidi Maybodi
Faculty of Dentistry, the beginning of Imam Reza Blvd, Imam Reza Square
Yazd Iran (Islamic Republic of) 8914881167 +98 35 3625 5881 f_rashidi63@ssu.ac.ir Yazd University of Medical Sciences Iran (Islamic Republic of) Age between 25 and 50 years Having periodontitis stage II to IV and grade A or B 25 years 50 years Both 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 F41.9 R52 Anxiety disorder, unspecified Pain, unspecified Treatment - Drugs Other 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). Control group: For this group, distilled water will be used for moistening the cotton/gas and rubbing around nostrils 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). 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). 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). 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. 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. Pain grade on Visual Analogue Scale. Timepoint: After scaling for two thirds of the teeth. Method of measurement: Visual Analogue scale. 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). Yazd University of Medical Sciences Approved 2023-12-11 Ethics Committee of Faculty of Dentistry_ Shahid Sadoughi University of Medical Sciences, Yazd Faculty of Dentistry, the beginning of Imam Reza Blvd, Imam Reza Square Yazd Yazd Iran (Islamic Republic of)