Essential Hypertension Clinical Trial
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.
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
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT03708601 -
Prognostic Risk of Patients With Essential Hypertension for Cardiovascular Events (PROSPECT)
|
||
Not yet recruiting |
NCT05503953 -
Phase III Study to Evaluate the Efficacy and Safety of AGSAVI in Patients With Essential Hypertension Inadequately Controlled With AGLS
|
Phase 3 | |
Recruiting |
NCT05526703 -
Clinical Trial to Evaluate the Efficacy and Safety of D064 and D701 Combination Therapy
|
Phase 3 | |
Completed |
NCT06395194 -
Effects of Valsartan vs Amlodipine and Low BP on Kidney Outcomes in Essential Hypertension
|
Phase 3 | |
Not yet recruiting |
NCT06418074 -
Effects of Exogenous Ketosis on Renal Function, Renal Perfusion, and Sodium Excretory Capacity
|
N/A | |
Completed |
NCT02890173 -
Study of CS-3150 in Patients With Essential Hypertension
|
Phase 3 | |
Completed |
NCT02944734 -
Comparison of Efficacy and Safety of Combination Therapy and Monotherapy of Candesartan and Amlodipine for Dose-Finding in Patients With Essential Hypertension
|
Phase 2 | |
Withdrawn |
NCT02096939 -
Microvascular Function in Primary Aldosteronism
|
N/A | |
Recruiting |
NCT01956786 -
Efficacy of Amlodipine-Folic Acid Tablets on Reduction of Blood Pressure and Plasma Homocysteine
|
Phase 2/Phase 3 | |
Completed |
NCT02553512 -
Helius in Hypertension-I: The UK Hypertension Registry
|
N/A | |
Completed |
NCT01198249 -
Pharmacokinetic Drug Interactions Between Single and Concomitant Administrations of Amlodipine, Losartan, and Hydrochlorothiazide in Subjects With (Pre)Hypertension
|
Phase 1 | |
Completed |
NCT01001572 -
Efficacy and Safety of Valsartan/Amlodipine in Patients With Mild to Moderate Essential Hypertension
|
Phase 3 | |
Recruiting |
NCT00380289 -
Early Metabolic Changes With Thiazide or Beta Blocker Therapy for Essential Hypertension
|
N/A | |
Completed |
NCT00139698 -
Olmesartan Alone or in Combination With Hydrochlorothiazide in Subjects With Mild to Moderate Essential Hypertension
|
Phase 3 | |
Completed |
NCT00288184 -
Uric Acid in Essential Hypertension in Children
|
Phase 2 | |
Completed |
NCT01289886 -
Fimasartan (BR-A-657) Single Oral Dose in Healthy Subjects
|
Phase 1 | |
Not yet recruiting |
NCT06041529 -
Study to Evaluate the Efficacy and Safety of TEL/AML/CTD in Elderly Patients With Essential Hypertension
|
Phase 4 | |
Completed |
NCT04470830 -
A Study for PMS of AZL-M/CLD FDC in the Treatment of Participants With Essential HTN in South Korea
|
||
Completed |
NCT00758524 -
A Study to Evaluate Efficacy and Safety of LCI699 in Participants With Essential Hypertension
|
Phase 2 | |
Recruiting |
NCT05109013 -
Juvenile Essential Arterial Hypertension and Vascular Function
|