The Effect of Aromatherapy on Sleep, Anxiety and Vital Signs in Those With Essential Hypertension (Hypertension)

NCT06482424 | Enrolling By Invitation

• 1 other identifier: 10636659
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

In addition to pharmacological agents in the treatment of hypertension, it has been reported in studies that aromatherapy applications, one of the traditional and complementary alternative treatments that are easy to apply nursing interventions with minimal side effects, have an effect on high blood pressure control. Studies have shown that aromatherapy has positive effects on stress management and anxiety control. Lavender oil, one of the frequently used aromatic oils, has antiseptic, anti-inflammatory, analgesic, muscle relaxant effects, regulates sleep with its relaxing and sedative effects, reduces the severity of itching, increases attention and facilitates learning, and reduces physical indicators of the autonomic nervous system such as pulse, respiratory rate and blood pressure. It has been shown in studies that it lowers In this study, the effect of lavender aromatic oil on sleep, anxiety and vital signs in individuals with essential hypertension will be evaluated. In the study, lavender oil will be administered to patients by inhalation for 5 minutes twice a day for 4 weeks. Medicinal lavender oil will be applied to the intervention group, and sesame oil will be applied to the placebo group. During the follow-up of the patients, the patient follow-up chart-researcher form will be evaluated at the beginning of the first week and at the end of the fourth week for each group. Vital signs, blood pressure and pulse rate, half an hour before and after aromatherapy in the morning and evening, 5 days a week for four weeks, will be evaluated with the Pittsburgh Sleep Quality Index and State-Trait Anxiety Scale at the beginning of the first week and at the end of the fourth week. The unique value of this study is that, unlike other studies, the applications will be applied in the morning and evening for 4 weeks, and sesame oil, which does not have an aromatic effect, will be used in the placebo group. As an expected patient outcome, we foresee improving the quality of life of patients by improving their sleep quality, reducing their anxiety level, and lowering their blood pressure by taking advantage of the healing effect of lavender aromatic oil in nursing practices.

Conditions

Hypertension; Aromatherapy

Keywords

Aromatherapy; Essential Hypertension; Internal Medicine Nursing

Outcome Measures

Primary Outcomes (1)

• The Effect of Aromatherapy on Sleep, Anxiety and Vital Signs in Individuals with Essential Hypertension

  In this study, the effect of lavender aromatic oil on sleep, anxiety and vital signs in individuals with essential hypertension will be evaluated. In the study, patients will be administered lavender oil by inhalation for 5 minutes twice a day for 4 weeks. Medicinal lavender oil will be applied to the intervention group, and sesame oil will be applied to the placebo group.

  1 yıl

Study Arms (2)

intervention group

EXPERIMENTAL

Actions to be taken to the Intervention Group The state-trait anxiety scale and Pittsburg Sleep Quality Index score will be recorded on the patient follow-up chart-researcher form by the researcher at the patient's home at the beginning of the first week and at the end of the fourth week. The aromatic oil given to patients in the intervention group will be placed in 10ml dark glass bottles with droppers and a numbered label will be attached to the bottle.

Other: intervention group

placebo group

EXPERIMENTAL

Procedures to be Performed on the Placebo Group The researcher will record the state-trait anxiety scale and Pittsburg Sleep Quality Index score on the patient follow-up chart-researcher form at the patient's home at the beginning of the first week and at the end of the fourth week. Sesame oil given to patients in the placebo group will be placed in 10 ml dark glass bottles with droppers and a label with number two will be attached to the bottle.

Other: intervention group

Interventions

intervention group OTHER

Actions to be taken to the Intervention Group The researcher will record the state-trait anxiety scale and Pittsburg Sleep Quality Index score on the patient follow-up chart-researcher form at the patient's home at the beginning of the first week and at the end of the fourth week. The aromatic oil given to patients in the intervention group will be placed in 10ml dark glass bottles with droppers and a numbered label will be attached to the bottle. Procedures to be Performed on the Placebo Group The researcher will record the state-trait anxiety scale and Pittsburg Sleep Quality Index score on the patient follow-up chart-researcher form at the patient's home at the beginning of the first week and at the end of the fourth week. Sesame oil given to patients in the placebo group will be placed in 10 ml dark glass bottles with droppers and a number two label will be attached to the bottle.

Also known as: placebo group

intervention group; placebo group

Eligibility Criteria

• Age: 18 Months - 65 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Those aged between 18-65,
• Understands Turkish, has good cognitive functions and can communicate,
• Followed with the diagnosis of essential hypertension for at least 1 year,
• Those receiving antihypertensive medical drug treatment, - There has been no change in antihypertensive drug treatment for the last 1 month,
• Do not have a chronic respiratory system disease (such as Asthma, COPD), which is important for the effectiveness of aromatherapy,
• Non-pregnant,
• Not receiving anxiolytic or hypnotic treatment for at least 6 months,
• Regularly measures blood pressure at home with its own semi-automatic blood pressure monitor on the upper arm,
• Not having any psychiatric diagnosis,
• Patients who agree to participate in the study will be included in the study.
• Those under the age of 18 and over the age of 65,
• Having difficulty in applying and understanding the treatment protocol,
• Having a psychiatric disease that impairs cognitive functions, such as bipolar disorder or schizophrenia,
• Having any respiratory system disease,
• Those who are allergic to or sensitive to the scent of lavender oil,

Sponsors & Collaborators

• TC Erciyes University: lead

Study Sites (1)

Niğde Bor Devlet Hastanesi

Merkez, Niğde Province, 51200, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Hypertension; Essential Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• esra doğan

  esramercan11021985@gmail.com.tr

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doktora Öğrencisi

Model Details: karma desen kullanılacaktır.

Study Record Dates

• First Submitted: June 12, 2024
• First Posted: July 1, 2024
• Study Start: September 1, 2024
• Primary Completion: March 9, 2025
• Study Completion: September 7, 2025
• Last Updated: July 1, 2024

Record last verified: 2024-06

Locations

TU (1)