Patient EngagementNCT05197569
The Effect of Aromatherapy With Thyme Oil on Disease Symptoms, Vital Signs, Hemodynamic Parameters in COVID-19 Patients
A study testing thyme oil in people with Patient Engagement, run by Inonu University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patient Engagement
- What is being tested?
- thyme oil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 31 Jan 2022to 14 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Batman Training and Research Hospital
Batman, 72070
About this study
Official title: 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.
Read the 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
- Being tested
- thyme oil
- Keywords
- Coronavirus, Covid-19, Aromatherapy, thyme oil, Thymus vulgaris
- Medical subject headings
- Patient Participation, Coronavirus Infections, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
thyme oilOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | No intervention will be applied to the control group and the measurements will be recorded simultaneously. |
| Thyme oil group | Experimental | 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. Receives: Other: thyme oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 .
Measured: 6 months
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.
Measured: 6 months
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.
Measured: 6 months
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.
Measured: 6 months
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2022
- Study start31 Jan 2022
- Primary completion14 Feb 2023
- Study completion14 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patient EngagementStudies of the same condition, open and under way.
- More trials run by Inonu UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- In the study, patients will be stratified according to their gender (male and female) status and the blocking process will be performed. In this study, block randomization will be done according to age groups in order to assign the participants to the experimental and control groups. Patients will be listed according to the hospitalization list and numbered up to 140. Numbers will be assigned to the experimental and control groups according to the random numbers list. Thus, the probability of each patient in the groups being in either of the intervention or control groups will be equalized. Group 1: experimental 2. Group: Control
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zeliha CENGİZ, Inonu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05197569
- Sponsor's protocol ID
- 2021/2637
- Status last verified
- Nov 2023
- First submitted
- 3 Jan 2022
- Last updated
- 15 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This research is a doctoral thesis study. The research is expected to be completed.
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Aromatherapy With Thyme Oil on Disease Symptoms, Vital Signs and Hemodynamic Parameters in COVID-19 Patients
- ClinicalTrials.gov ID
- NCT05197569
- Acronym / sponsor ID
- 2021/2637
- Conditions
- Patient Engagement
- Keywords
- Coronavirus, Covid-19, Aromatherapy, thyme oil, Thymus vulgaris
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Inonu UniversityUniversity, hospital or other
- Study start
- 31 Jan 2022 (actual)
- Primary completion
- 14 Feb 2023 (actual)
- Study completion
- 14 Feb 2023 (actual)
- First posted
- 19 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- In the study, patients will be stratified according to their gender (male and female) status and the blocking process will be performed. In this study, block randomization will be done according to age groups in order to assign the participants to the experimental and control groups. Patients will be listed according to the hospitalization list and numbered up to 140. Numbers will be assigned to the experimental and control groups according to the random numbers list. Thus, the probability of each patient in the groups being in either of the intervention or control groups will be equalized. Group 1: experimental 2. Group: Control
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –No intervention will be applied to the control group and the measurements will be recorded simultaneously. |
| Thyme oil group | Experimental | Other: thyme oilAfter 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| thyme oilThyme 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 group |
Primary outcome
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 .
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2023.
- Individual participant dataSharing planned: No. This research is a doctoral thesis study. The research is expected to be completed.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing thyme oil in people with Patient Engagement, run by Inonu University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Demographic Characteristics Form (time frame: 6 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2023.