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

November 14, 2023 updated by: Zeliha CENGİZ, Inonu University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

140

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Batman, Turkey, 72070
        • Batman Training and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control group
No intervention will be applied to the control group and the measurements will be recorded simultaneously.
Experimental: Thyme oil group
After filling out the forms, thyme oil aromatherapy will be applied to the patients assigned to the experimental group .The oregano oil to be prepared must have a high carvacrol ratio. 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Demographic Characteristics Form
Time Frame: 6 months
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
Covid-19 Symptom Form
Time Frame: 6 months
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
Hemodynamic parameters form
Time Frame: 6 months
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
Visual Comparison Scale
Time Frame: 6 months
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
Vital signs follow-up form
Time Frame: 6 months
Vital signs follow-up form was created to record the patient's daily fever, pulse, respiratory rate, systolic diastolic blood pressure values.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Inonu University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 31, 2022

Primary Completion (Actual)

February 14, 2023

Study Completion (Actual)

February 14, 2023

Study Registration Dates

First Submitted

January 3, 2022

First Submitted That Met QC Criteria

January 15, 2022

First Posted (Actual)

January 19, 2022

Study Record Updates

Last Update Posted (Actual)

November 15, 2023

Last Update Submitted That Met QC Criteria

November 14, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021/2637

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

This research is a doctoral thesis study. The research is expected to be completed.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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