Effects of Aromatherapy in Hypertensive Individuals

NCT04460300 | Unknown

• 1 other identifier: AIBU-HSF-SCC-02
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

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.

Conditions

Essential Hypertension; Aromatherapy; Stress, Physiological

Keywords

Essential Hypertension; Aromatherapy; Physiological Stress Response; Anxiety; Arterial Pressure

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  up to one week

Study Arms (3)

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.

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).

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.

Interventions

Aromatherapy-inhalation method 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-inhalation group

Aromatherapy-foot massage group 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).

Aromatherapy-foot massage group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Abant Izzet Baysal University: lead

Study Sites (1)

Bolu Elderly Health Center

Bolu, Turkey (Türkiye)

RECRUITING

Related Publications (1)

• 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.

  PMID: 35708557 DERIVED

MeSH Terms

Conditions

Essential Hypertension; Anxiety Disorders

Condition Hierarchy (Ancestors)

Hypertension; Vascular Diseases; Cardiovascular Diseases; Mental Disorders

Study Officials

• Saadet Can Cicek

  Bolu Abant Izzet Baysal University, Health Sciences Faculty

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hospital Chief Physician, Dr

CONTACT

0374 253 46 26; bolueah1@saglik.gov.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2020
• First Posted: July 7, 2020
• Study Start: December 3, 2018
• Primary Completion: August 3, 2020
• Study Completion: August 3, 2020
• Last Updated: July 7, 2020

Record last verified: 2020-07

Locations

TU (1)