Essential HypertensionNCT04460300
Effects of Aromatherapy in Hypertensive Individuals
A study testing Aromatherapy-inhalation method and Aromatherapy-foot massage group in people with Essential Hypertension and Aromatherapy, run by Abant Izzet Baysal University at 1 site in Turkey (Türkiye).
Trial summary
Objective: To investigate the effect of aromatherapy on blood pressure and stress response by inhalation and foot massage in individuals with essential hypertension. Methods: The randomized controlled trial is performed with 69 individuals diagnosed with essential hypertension hospitalized. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Essential Hypertension, Aromatherapy, Stress, Physiological
- What is being tested?
- Aromatherapy-inhalation method and Aromatherapy-foot massage group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Dec 2018to 3 Aug 2020
- 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
- 18 years and over,
- Have been diagnosed with essential hypertension for at least 6 months,
- Blood pressure values are 120-180 mmHg for systolic pressure and 80-110 mmHg for diastolic pressure,
- Receiving regular antihypertensive therapy,
- No additional antihypertensive drug is added during the application,
- Passing the odor sense test,
Show all 14Show fewer
- No current anxiolytic or hypnotic treatment,
- Not diagnosed with psychiatric illness,
- Not pre-applied,
- Those who understand and speak Turkish,
- No speech, hearing and vision loss,
- Non-smoker,
- Does not apply herbal treatment to lower blood pressure,
- Individuals who agreed to participate in the research
Who cannot join
- An additional antihypertensive drug was added during the application,
- Before each intervention, SKB ≥ 180 or <120 mmHg and DKB ≥ 110 or <80 mmHg,
- Taking dialysis treatment,
- In addition to its existing diseases, it is diagnosed with asthma, COPD and acute myocardial infarction.
- With a known allergic response to lavender oil,
- Applying herbal treatment to lower blood pressure,
Show all 14Show fewer
- Those who cannot pass the odor sense test,
- Receiving current anxiolytic or hypnotic treatment,
- Diagnosed with psychiatric illness,
- Pre-implemented,
- Who cannot understand and speak Turkish,
- Speech, hearing and vision loss,
- Smoker,
- Individuals who do not agree to participate in the research
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Bolu Elderly Health Center
Bolu
Bolu Governorship
About this study
Official title: The Effect of Aromatherapy Through Inhalation and Foot Massage on Blood Pressure and Stress Response in Individuals With Essential Hypertension
Objective: To investigate the effect of aromatherapy on blood pressure and stress response by inhalation and foot massage in individuals with essential hypertension.
Methods: The randomized controlled trial is performed with 69 individuals diagnosed with essential hypertension hospitalized. There are two interventions (group 1: aromatherapy-inhalation method, group 2: aromatherapy-foot massage) and a control group in the study. Blood pressure is measured with a digital sphygmomanometer after 10 minutes of rest; stress response is determined by heart rate, blood cortisol levels and anxiety scale. Aromatherapy with lavender oil is applied to the intervention groups; no application is made to the control group and routine follow-up at the hospital continued.
Read the detailed description
Objective: The primary aim of the study is to investigate the effect of aromatherapy on blood pressure and stress response by inhalation and foot massage in individuals with essential hypertension. Secondary aims;
- to define the effect of aromatherapy inhalation method and foot massage application on blood pressure and heart rate in individuals with essential hypertension,
- to define the effects of aromatherapy inhalation method and foot massage application on blood cortisol levels in individuals with essential hypertension,
- to define the effects of aromatherapy inhalation method and foot massage application on anxiety scores in individuals with essential hypertension.
Hypothesis:
- H0-1: Aromatherapy inhalation method has no significant effect on blood pressure in individuals with essential hypertension.
- H1-1: Aromatherapy inhalation method has a significant effect on blood pressure in individuals with essential hypertension.
- H0-2: Aromatherapy inhalation method does not have a significant effect on stress response in individuals with essential hypertension.
- H1-2: Aromatherapy inhalation method has a significant effect on stress response in individuals with essential hypertension.
- H0-3: Foot massage application does not have a significant effect on blood pressure in individuals with essential hypertension.
- H1-3: Foot massage application has a significant effect on blood pressure in individuals with essential hypertension.
- H0-4: Foot massage application in patients with essential hypertension has no significant effect on stress response.
- H1-4: Foot massage application in patients with essential hypertension has a significant effect on stress response.
Methods: The randomized controlled trial is performed with 69 individuals diagnosed with essential hypertension hospitalized.There are two interventions (group 1: aromatherapy-inhalation method, group 2: aromatherapy-foot massage) and a control group in the study. In power analysis based on blood cortisol level,80% power, 95% confidence interval, effect size 0.39, standard deviation 3.09 were calculated and 23 participants in each group were determined. Blood pressure is measured with a digital sphygmomanometer after 10 minutes of rest; stress response is determined by heart rate, blood cortisol levels and anxiety scale. Aromatherapy with lavender oil is applied to the intervention groups; no application is made to the control group and routine follow-up at the hospital continued. The group-1 smells sterile cloth with 5 drops of lavender oil for five minutes and is done every other day for three days. Group-2 receives a total of 20 minutes of foot massage with 5 drops of lavender oil for each foot and is applied every other day for three days. Aromatherapy is performed between 07:00 and 08:00 in the morning hours when the blood cortisol value peaked at the highest level and homogeneity is achieved in terms of application.
Measures: For intervention groups (group 1 and 2), blood pressure and heart rate will be measured seven times in total, both at the first interview and before and after each application, 10 minutes after the application; for control group, it is a total of seven times, both once in the first interview and twice every other day. Blood cortisol level is measured four times in total for the intervention groups, both at the beginning and after each application; For the control group, it is measured at the same time as the intervention groups at baseline and on the third follow-up day (twice in total). Anxiety scale (Spielberger State-Trait Anxiety Inventory) is used for subjective stress response. Trait Anxiety Inventory is evaluated at the beginning of the study for both groups (only once). State Anxiety Inventory, for intervention groups, is applied four times both before and after the first application and before and after the third application; for control group is applied twice, on the first follow-up day and on the third follow-up day.
Analysis: Statistical methods to be used for study data;
- Descriptive statistics (number and percentage, average, standard deviation)
- T test (Parametric), Mann Whitney U test (nonparametric) (according to the suitability of the data for normal distribution)
- One-way anova (Parametric), Kruskal Wallis Test (nonparametric) (according to the normal distribution of data)
- Pearson / Spearman Correlation (according to the suitability of the data for normal distribution)
- Analysis of variance in repeated measurements
- Regression analysis
- Conditions
- Essential Hypertension, Aromatherapy, Stress, Physiological
- Being tested
- Aromatherapy-inhalation method, Aromatherapy-foot massage group
- Keywords
- Essential Hypertension, Aromatherapy, Physiological Stress Response, Anxiety, Arterial Pressure
- Medical subject headings
- Essential Hypertension, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aromatherapy-inhalation methodOther
In addition to the pharmacological treatment prescribed by the physician to individuals in this group, aromatherapy is carried out through the essential oil inhalation method. Individuals who can distinguish odors in the odor sense test before the application is included in the study. Aromatherapy inhalation is applied for three days and every other day (eg Monday-Wednesday-Friday) determined by the researchers for a week. Intervention is made between 07:00 and 08:00 in the morning hours when the blood cortisol value is maximized and homogeneity is provided.
In this method, 5 drops of lavender oil will be dropped directly on a sterile gauze and individuals will be allowed to breathe from a distance of 10 cm for 5 minutes.
Aromatherapy-foot massage groupOther
In addition to the pharmacological treatment prescribed by the physician to individuals in this group, aromatherapy is applied through foot massage. Swedish massage protocol is followed in foot massage intervention.The foot massage is performed on three days and every other day (eg Monday-Wednesday-Friday) determined by the researchers for a week.The intervention is performed between 07:00 and 08:00 in the morning hours when the blood cortisol value is maximized and homogeneity is provided.
Foot massage is done with 10 drops (5 drops per foot) of lavender for 10 minutes for each foot for 20 minutes. During the intervention, 20 techniques is used and the application time of each technique is 30 seconds (total 10 minutes per foot).
| Study group | Role | What they receive |
|---|---|---|
| Aromatherapy-inhalation group | Experimental | In addition to the pharmacological treatment prescribed by the physician to individuals in this group, aromatherapy is carried out through the essential oil inhalation method. Individuals who can distinguish odors in the odor sense test before the application is included in the study. Aromatherapy inhalation is applied for three days and every other day (eg Monday-Wednesday-Friday) determined by the researchers for a week. Intervention is made between 07:00 and 08:00 in the morning hours when the blood cortisol value is maximized and homogeneity is provided.
In this method, 5 drops of lavender oil is dropped directly on a sterile gauze and individuals is allowed to breathe from a distance of 10 cm for 5 minutes. Receives: Other: Aromatherapy-inhalation method |
| Aromatherapy-foot massage group | Experimental | In addition to the pharmacological treatment prescribed by the physician to individuals in this group, aromatherapy is applied through foot massage. Swedish massage protocol is followed in foot massage intervention.The foot massage is performed on three days and every other day (eg Monday-Wednesday-Friday) determined by the researchers for a week.The intervention is performed between 07:00 and 08:00 in the morning hours when the blood cortisol value is maximized and homogeneity is provided.
Foot massage is done with 10 drops (5 drops per foot) of lavender for 10 minutes for each foot for 20 minutes. During the intervention, 20 techniques is used and the application time of each technique is 30 seconds (total 10 minutes per foot). Receives: Other: Aromatherapy-foot massage group |
| Control group | No intervention | Interviews is held with the control group while performing the routine treatment and care of the clinic. No intervention is made by the researchers to the control group during the interview. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean of blood pressure (mmHg)
In the study, a digital sphygmomanometer, which has been calibrated in comparison with the mercury sphygmomanometer, is used in order to prevent individual differences in the measurement of blood pressure. For accurate results, the sphygmomanometer sleeve is sized for adult individuals (width = about 20 cm, length = about 40 cm). In order for the blood pressure not to be affected by the conditions during the measurement, it is taken into account that the individual did not drink tea or coffee, take caffeine, and preferably did not eat during the 30 minutes prior to measurement. Measurements are made after the individual has been resting in a quiet room for at least 10 minutes. The measurements at the first interview are made from both arms, the blood pressure in the high arm is considered to be the blood pressure of the patient. Blood pressure measurements in the follow-ups are also made from this arm.
Measured: up to one week
Mean of heart rate (/dk)
The heart rate is the pressure of the left ventricle on the vascular wall of the blood that it throws into the aorta during systole from the skin surface.In the research, apical heart rate is measured with a stethoscope.
Measured: up to one week
Mean of blood cortisol level (mg/dl)
Adrenal cortisol release is largely regulated by the limbic system-hypothalamus-pituitary and adrenal (L-HPA) axis.When an individual detects an environmental stimulus or stress to be avoided, activation of the HPA-axis is initiated in the central nervous system, and a physiological process occurs to stimulate the adrenal gland to release glucocorticoids for cortisol release.There are sources showing that the maximum cortisol values are between 04:00 and 08:00. The half-life of cortisol in circulation is 60 minutes, so the blood concentration changes rapidly. For this reason, interventions in the study are performed within hours when the serum cortisol level is highest and blood will be drawn for cortisol 5 minutes after the application.
Measured: up to one week
Means of subjective anxiety scores
Spielberger State-Trait Anxiety Inventory is used to measure subjective anxiety scores.The State Anxiety Inventory is a 4-point Likert-type scale consisting of 20 questions aimed at measuring how individuals are feeling right now.The Trait Anxiety Inventory is a 20-item scale that generally determines how the individual feels, regardless of the situation and circumstances in which the individual is present.
Measured: up to one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2020
- Study start3 Dec 2018
- Primary completion3 Aug 2020 (estimated)
- Study completion3 Aug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Essential HypertensionStudies of the same condition, open and under way.
- More trials run by Abant Izzet Baysal 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
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 69 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abant Izzet Baysal University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Saadet Can Cicek, Principal investigator, Bolu Abant Izzet Baysal University, Health Sciences Faculty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04460300
- Sponsor's protocol ID
- AIBU-HSF-SCC-02
- Status last verified
- Jul 2020
- First submitted
- 21 Jun 2020
- Last updated
- 7 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Can Cicek S, Demir S, Yilmaz D, Acikgoz A, Yildiz S, Yis OM. The Effect of Aromatherapy on Blood Pressure and Stress Responses by Inhalation and Foot Massage in Patients With Essential Hypertension: Randomized Clinical Trial. Holist Nurs Pract. 2022 Jul-Aug 01;36(4):209-222. doi: 10.1097/HNP.0000000000000526.
PubMed 35708557
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Aromatherapy Through Inhalation and Foot Massage on Blood Pressure and Stress Response in Individuals With Essential Hypertension
- ClinicalTrials.gov ID
- NCT04460300
- Acronym / sponsor ID
- AIBU-HSF-SCC-02
- Conditions
- Essential Hypertension, Aromatherapy, Stress, Physiological
- Keywords
- Essential Hypertension, Aromatherapy, Physiological Stress Response, Anxiety, Arterial Pressure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 69 participants (estimated)
- Lead sponsor
- Abant Izzet Baysal UniversityUniversity, hospital or other
- Study start
- 3 Dec 2018 (actual)
- Primary completion
- 3 Aug 2020 (estimated)
- Study completion
- 3 Aug 2020 (estimated)
- First posted
- 7 Jul 2020 (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.
Objective: To investigate the effect of aromatherapy on blood pressure and stress response by inhalation and foot massage in individuals with essential hypertension.
Methods: The randomized controlled trial is performed with 69 individuals diagnosed with essential hypertension hospitalized. There are two interventions (group 1: aromatherapy-inhalation method, group 2: aromatherapy-foot massage) and a control group in the study. Blood pressure is measured with a digital sphygmomanometer after 10 minutes of rest; stress response is determined by heart rate, blood cortisol levels and anxiety scale. Aromatherapy with lavender oil is applied to the intervention groups; no application is made to the control group and routine follow-up at the hospital continued.
Detailed description
Objective: The primary aim of the study is to investigate the effect of aromatherapy on blood pressure and stress response by inhalation and foot massage in individuals with essential hypertension. Secondary aims;
- to define the effect of aromatherapy inhalation method and foot massage application on blood pressure and heart rate in individuals with essential hypertension,
- to define the effects of aromatherapy inhalation method and foot massage application on blood cortisol levels in individuals with essential hypertension,
- to define the effects of aromatherapy inhalation method and foot massage application on anxiety scores in individuals with essential hypertension.
Hypothesis:
- H0-1: Aromatherapy inhalation method has no significant effect on blood pressure in individuals with essential hypertension.
- H1-1: Aromatherapy inhalation method has a significant effect on blood pressure in individuals with essential hypertension.
- H0-2: Aromatherapy inhalation method does not have a significant effect on stress response in individuals with essential hypertension.
- H1-2: Aromatherapy inhalation method has a significant effect on stress response in individuals with essential hypertension.
- H0-3: Foot massage application does not have a significant effect on blood pressure in individuals with essential hypertension.
- H1-3: Foot massage application has a significant effect on blood pressure in individuals with essential hypertension.
- H0-4: Foot massage application in patients with essential hypertension has no significant effect on stress response.
- H1-4: Foot massage application in patients with essential hypertension has a significant effect on stress response.
Methods: The randomized controlled trial is performed with 69 individuals diagnosed with essential hypertension hospitalized.There are two interventions (group 1: aromatherapy-inhalation method, group 2: aromatherapy-foot massage) and a control group in the study. In power analysis based on blood cortisol level,80% power, 95% confidence interval, effect size 0.39, standard deviation 3.09 were calculated and 23 participants in each group were determined. Blood pressure is measured with a digital sphygmomanometer after 10 minutes of rest; stress response is determined by heart rate, blood cortisol levels and anxiety scale. Aromatherapy with lavender oil is applied to the intervention groups; no application is made to the control group and routine follow-up at the hospital continued. The group-1 smells sterile cloth with 5 drops of lavender oil for five minutes and is done every other day for three days. Group-2 receives a total of 20 minutes of foot massage with 5 drops of lavender oil for each foot and is applied every other day for three days. Aromatherapy is performed between 07:00 and 08:00 in the morning hours when the blood cortisol value peaked at the highest level and homogeneity is achieved in terms of application.
Measures: For intervention groups (group 1 and 2), blood pressure and heart rate will be measured seven times in total, both at the first interview and before and after each application, 10 minutes after the application; for control group, it is a total of seven times, both once in the first interview and twice every other day. Blood cortisol level is measured four times in total for the intervention groups, both at the beginning and after each application; For the control group, it is measured at the same time as the intervention groups at baseline and on the third follow-up day (twice in total). Anxiety scale (Spielberger State-Trait Anxiety Inventory) is used for subjective stress response. Trait Anxiety Inventory is evaluated at the beginning of the study for both groups (only once). State Anxiety Inventory, for intervention groups, is applied four times both before and after the first application and before and after the third application; for control group is applied twice, on the first follow-up day and on the third follow-up day.
Analysis: Statistical methods to be used for study data;
- Descriptive statistics (number and percentage, average, standard deviation)
- T test (Parametric), Mann Whitney U test (nonparametric) (according to the suitability of the data for normal distribution)
- One-way anova (Parametric), Kruskal Wallis Test (nonparametric) (according to the normal distribution of data)
- Pearson / Spearman Correlation (according to the suitability of the data for normal distribution)
- Analysis of variance in repeated measurements
- Regression analysis
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Aromatherapy-inhalation group | Experimental | Other: Aromatherapy-inhalation methodIn addition to the pharmacological treatment prescribed by the physician to individuals in this group, aromatherapy is carried out through the essential oil inhalation method. Individuals who can distinguish odors in the odor sense test before the application is included in the study. Aromatherapy inhalation is applied for three days and every other day (eg Monday-Wednesday-Friday) determined by the researchers for a week. Intervention is made between 07:00 and 08:00 in the morning hours when the blood cortisol value is maximized and homogeneity is provided. In this method, 5 drops of lavender oil is dropped directly on a sterile gauze and individuals is allowed to breathe from a distance of 10 cm for 5 minutes. |
| Aromatherapy-foot massage group | Experimental | Other: Aromatherapy-foot massage groupIn addition to the pharmacological treatment prescribed by the physician to individuals in this group, aromatherapy is applied through foot massage. Swedish massage protocol is followed in foot massage intervention.The foot massage is performed on three days and every other day (eg Monday-Wednesday-Friday) determined by the researchers for a week.The intervention is performed between 07:00 and 08:00 in the morning hours when the blood cortisol value is maximized and homogeneity is provided. Foot massage is done with 10 drops (5 drops per foot) of lavender for 10 minutes for each foot for 20 minutes. During the intervention, 20 techniques is used and the application time of each technique is 30 seconds (total 10 minutes per foot). |
| Control group | No intervention | –Interviews is held with the control group while performing the routine treatment and care of the clinic. No intervention is made by the researchers to the control group during the interview. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 18 years and over,
- Have been diagnosed with essential hypertension for at least 6 months,
- Blood pressure values are 120-180 mmHg for systolic pressure and 80-110 mmHg for diastolic pressure,
- Receiving regular antihypertensive therapy,
- No additional antihypertensive drug is added during the application,
Key exclusion criteria (14 listed)
- An additional antihypertensive drug was added during the application,
- Before each intervention, SKB ≥ 180 or <120 mmHg and DKB ≥ 110 or <80 mmHg,
- Taking dialysis treatment,
- In addition to its existing diseases, it is diagnosed with asthma, COPD and acute myocardial infarction.
- With a known allergic response to lavender oil,
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 |
|---|---|---|
| Aromatherapy-inhalation methodIn addition to the pharmacological treatment prescribed by the physician to individuals in this group, aromatherapy is carried out through the essential oil inhalation method. Individuals who can distinguish odors in the odor sense test before the application is included in the study. Aromatherapy inhalation is applied for three days and every other day (eg Monday-Wednesday-Friday) determined by the researchers for a week. Intervention is made between 07:00 and 08:00 in the morning hours when the blood cortisol value is maximized and homogeneity is provided. In this method, 5 drops of lavender oil will be dropped directly on a sterile gauze and individuals will be allowed to breathe from a distance of 10 cm for 5 minutes. | Other | Aromatherapy-inhalation group |
| Aromatherapy-foot massage groupIn addition to the pharmacological treatment prescribed by the physician to individuals in this group, aromatherapy is applied through foot massage. Swedish massage protocol is followed in foot massage intervention.The foot massage is performed on three days and every other day (eg Monday-Wednesday-Friday) determined by the researchers for a week.The intervention is performed between 07:00 and 08:00 in the morning hours when the blood cortisol value is maximized and homogeneity is provided. Foot massage is done with 10 drops (5 drops per foot) of lavender for 10 minutes for each foot for 20 minutes. During the intervention, 20 techniques is used and the application time of each technique is 30 seconds (total 10 minutes per foot). | Other | Aromatherapy-foot massage group |
Primary outcome
Mean of blood pressure (mmHg)
Time frame: up to one week
In the study, a digital sphygmomanometer, which has been calibrated in comparison with the mercury sphygmomanometer, is used in order to prevent individual differences in the measurement of blood pressure. For accurate results, the sphygmomanometer sleeve is sized for adult individuals (width = about 20 cm, length = about 40 cm). In order for the blood pressure not to be affected by the conditions during the measurement, it is taken into account that the individual did not drink tea or coffee, take caffeine, and preferably did not eat during the 30 minutes prior to measurement. Measurements are made after the individual has been resting in a quiet room for at least 10 minutes. The measurements at the first interview are made from both arms, the blood pressure in the high arm is considered to be the blood pressure of the patient. Blood pressure measurements in the follow-ups are also made from this arm.
Mean of heart rate (/dk)
Time frame: up to one week
The heart rate is the pressure of the left ventricle on the vascular wall of the blood that it throws into the aorta during systole from the skin surface.In the research, apical heart rate is measured with a stethoscope.
Mean of blood cortisol level (mg/dl)
Time frame: up to one week
Adrenal cortisol release is largely regulated by the limbic system-hypothalamus-pituitary and adrenal (L-HPA) axis.When an individual detects an environmental stimulus or stress to be avoided, activation of the HPA-axis is initiated in the central nervous system, and a physiological process occurs to stimulate the adrenal gland to release glucocorticoids for cortisol release.There are sources showing that the maximum cortisol values are between 04:00 and 08:00. The half-life of cortisol in circulation is 60 minutes, so the blood concentration changes rapidly. For this reason, interventions in the study are performed within hours when the serum cortisol level is highest and blood will be drawn for cortisol 5 minutes after the application.
Means of subjective anxiety scores
Time frame: up to one week
Spielberger State-Trait Anxiety Inventory is used to measure subjective anxiety scores.The State Anxiety Inventory is a 4-point Likert-type scale consisting of 20 questions aimed at measuring how individuals are feeling right now.The Trait Anxiety Inventory is a 20-item scale that generally determines how the individual feels, regardless of the situation and circumstances in which the individual is present.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2020.
- Derived from this study: PubMed 35708557Can Cicek S, Demir S, Yilmaz D, Acikgoz A, Yildiz S, Yis OM. The Effect of Aromatherapy on Blood Pressure and Stress Responses by Inhalation and Foot Massage in Patients With Essential Hypertension: Randomized Clinical Trial. Holist Nurs Pract. 2022 Jul-Aug 01;36(4):209-222. doi: 10.1097/HNP.0000000000000526.
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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.
Saadet Can Cicek principal investigator
Bolu Abant Izzet Baysal University, Health Sciences Faculty
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aromatherapy-inhalation method and Aromatherapy-foot massage group in people with Essential Hypertension and Aromatherapy, run by Abant Izzet Baysal 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 14 inclusion and 14 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: status not confirmed, as of the sponsor's last update on 7 Jul 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hospital Chief Physician, Dr (0374 253 46 26, bolueah1@saglik.gov.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean of blood pressure (mmHg) (time frame: up to one week). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04460300, which also lists 1 linked publication.
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 7 Jul 2020.