Effects of Aromatherapy in Hypertensive Individuals

NCT ID: NCT04460300

Last Updated: 2020-07-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 69 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-03
• Study Completion Date: 2020-08-03

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

Conditions

Essential Hypertension; Aromatherapy; Stress, Physiological

Study Design

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

Study Groups

Aromatherapy-inhalation group

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.

Group Type: EXPERIMENTAL

Aromatherapy-inhalation method

Intervention Type: OTHER

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 group

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).

Group Type: EXPERIMENTAL

Aromatherapy-foot massage group

Intervention Type: OTHER

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).

Control group

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Aromatherapy-inhalation method

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.

Intervention Type: OTHER

Aromatherapy-foot massage group

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).

Intervention Type: OTHER

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

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

Sponsors

Abant Izzet Baysal University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Saadet Can Cicek

Role: PRINCIPAL_INVESTIGATOR

Bolu Abant Izzet Baysal University, Health Sciences Faculty

Locations

Bolu Elderly Health Center

Bolu, , Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Central Contacts

Hospital Chief Physician, Dr

Role: CONTACT

bolueah1@saglik.gov.tr

0374 253 46 26

Facility Contacts

Bolu Governorship

Role: primary

References

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.

Reference Type: DERIVED

PMID: 35708557 (View on PubMed)

Other Identifiers

AIBU-HSF-SCC-02

Identifier Type: -

Identifier Source: org_study_id