Clinical trial NCT04460300: Effects of Aromatherapy in Hypertensive Individuals
Official title: The Effect of Aromatherapy Through Inhalation and Foot Massage on Blood Pressure and Stress Response in Individuals With Essential Hypertension
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Essential Hypertension
Aromatherapy
Stress, Physiological
Keywords: Essential Hypertension
Aromatherapy
Physiological Stress Response
Anxiety
Arterial Pressure
Lead sponsor: Abant Izzet Baysal University
Sponsor class: OTHER
First posted: 2020-07-07
Enrollment: 69
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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. 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

Eligibility criteria: Inclusion Criteria:

* 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,
* 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

Exclusion Criteria:

* 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,
* 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

Primary outcomes:
measure: Mean of blood pressure (mmHg)
timeFrame: up to one week
measure: Mean of heart rate (/dk)
timeFrame: up to one week
measure: Mean of blood cortisol level (mg/dl)
timeFrame: up to one week
measure: Means of subjective anxiety scores
timeFrame: up to one week
Secondary outcomes:
Other outcomes:
Locations:
city: Bolu
country: Turkey
facility: Bolu Elderly Health Center
Study officials:
affiliation: Bolu Abant Izzet Baysal University, Health Sciences Faculty
name: Saadet Can Cicek
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.