The Effect of Aromatherapy With Thyme Oil on Disease Symptoms, Vital Signs, Hemodynamic Parameters in COVID-19 Patients

Patient Engagement Clinical Trial

Official title:

The Effect of Aromatherapy With Thyme Oil on Disease Symptoms, Vital Signs and Hemodynamic Parameters in COVID-19 Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05197569
• Other study ID #: 2021/2637
• Status: Completed
• Phase: N/A
• Start date: January 31, 2022
• Est. completion date: February 14, 2023

Study information

• Verified date: November 2023
• Source: Inonu University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Coronavirus, which is a common infectious disease, is characterized by symptoms such as severe pain, cough, shortness of breath, dizziness, secretion, diarrhea, nausea-vomiting, weakness, runny nose, changes in sense of taste and smell, and loss of appetite. The use of thyme is common for this disease whose standard treatment is still being discussed. However, studies investigating the effectiveness of oregano oil are limited. These few studies in the literature have focused especially on the effects of thyme oil on Covid-19 symptoms. This work; It will be done to evaluate the effect of aromatherapy with thyme oil on Covid-19 symptoms, vital signs and hemodynamic parameters in Covid-19 patients. There is no study in the literature investigating the effects of all these variables.

Description:

Coronavirus, which is a common infectious disease, is characterized by symptoms such as severe pain, cough, shortness of breath, dizziness, secretion, diarrhea, nausea-vomiting, weakness, runny nose, changes in sense of taste and smell, and loss of appetite. The use of thyme is common for this disease whose standard treatment is still being discussed. However, studies investigating the effectiveness of oregano oil are limited. These few studies in the literature have focused especially on the effects of thyme oil on Covid-19 symptoms. This work; It will be done to evaluate the effect of aromatherapy with thyme oil on Covid-19 symptoms, vital signs and hemodynamic parameters in Covid-19 patients. There is no study in the literature investigating the effects of all these variables. The study will be carried out as a randomized controlled experimental study. It will be carried out in Batman Training and Research Hospital Covid-19 service between January 2022 and December 2022. The sample of the study will consist of a total of 140 patients (experimental group = 70 control group = 70) randomized to the experimental and control groups.

In data collection, "Demographic Characteristics Form", "Covid-19 Symptom Form", "Hemodynamic parameters and vital signs follow-up form" and "Visual Comparison Scale (VAS)" will be used. Kolmogorov Smirnov normality test will be used for normal distribution in the analysis of the data. Using ANOVA, ANCOVA, student t test and paired t test in the analysis of normally distributed data; Fridman test, Kruskal Wallis and Man Withney U test are planned to be used in the analysis of data that is not normally distributed.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: February 14, 2023
• Est. primary completion date: February 14, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• PCR test positive

• Being in the covid-19 service

• Involvement in the lung as a result of computed tomography between 50-80% to be

• The day of admission to the Covid 19 service (1. Day) sickareceipt of

Exclusion Criteria:

• Having a pregnancy status

• be under the age of 18

• unwillingness to participate in the study

• Patients who will be transferred to the intensive care unit will be excluded from the study.

Related Conditions & MeSH terms

• COVID-19
• Patient Engagement

Intervention

Other:
• thyme oil
Thyme oil with a carvacrol ratio of at least 74% will be specific to each patient and will be given to the patient in the form of an inhaler stick. According to expert opinion; The patient's own room should be visited every 8 hours and the patient-specific inhaler stick should be sniffed into 8 breathing lungs. Each patient will use an inhaler stick for 5 days. Hemodynamic parameters (ph, CO 2, O 2 ) and Covid-19 symptoms will be measured before the intervention with the patient (pretest) and at the end of the 5th day (posttest). Vital signs will be measured and recorded three times a day in the patient's room at 08:00, 16:00 and 24:00.

Locations

Country	Name	City	State
Turkey	Batman Training and Research Hospital	Batman

Sponsors (1)

Lead Sponsor	Collaborator
Inonu University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Demographic Characteristics Form	This form, created by the researchers, consists of 10 questions in total, questioning the characteristics of diagnosis, weight, gender, chronic disease status and Covid-19 .	6 months
Primary	Covid-19 Symptom Form	This form, which was created by the researchers with the support of the literature, consists of 13 questions that include evaluations that measure the patient's Covid-19 symptoms and the level of severity.	6 months
Primary	Hemodynamic parameters form	From the blood gas values of this form created by the researcher; It was created to record the pH, O 2 , CO 2 , SaO 2 measurement results.	6 months
Primary	Visual Comparison Scale	This scale is the most widely used scale for pain assessment. In this study, it will be used for the evaluation of muscle-joint pain and headache, which are the symptoms of Covid-19. Usually 10 cm long, horizontally or vertically; It is the line from "No Pain" (0 point) to "Severe Pain" (10 points). As the score on the visual comparison scale increases, the severity of the disease increases. This line can be straight or vertical. It may include words or numbers used to describe pain, written on evenly spaced lines. It is generally accepted that the horizontal line is easier to understand.	6 months
Primary	Vital signs follow-up form	Vital signs follow-up form was created to record the patient's daily fever, pulse, respiratory rate, systolic diastolic blood pressure values.	6 months