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

NCT ID: NCT05197569

Last Updated: 2023-11-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-31
• Study Completion Date: 2023-02-14

Brief 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.

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.

Conditions

Patient Engagement

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Control group

No intervention will be applied to the control group and the measurements will be recorded simultaneously.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

thyme oil

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Inonu University

OTHER

Sponsor Role: lead

Responsible Party

Zeliha CENGİZ

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Batman Training and Research Hospital

Batman, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

2021/2637

Identifier Type: -

Identifier Source: org_study_id