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临床试验/NCT07192783
NCT07192783招募中不适用

Effects of Lavender Oil Inhalation Applied to Patients With Primary Hypertension on Anxiety, Sleep Quality and Blood Pressure

Ardahan University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2025年7月7日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
50
试验地点
1
主要终点
Anxiety

研究概览

简要总结

This study aims to determine the effects of lavender oil inhalation on anxiety, sleep quality, and blood pressure in patients with primary hypertension. The study is designed as a double-blind randomized controlled trial. The study population consists of patients presenting to the Cardiology Outpatient Clinic of Ardahan State Hospital. Participants are randomly assigned to an experimental group, which will receive a total of 12 lavender oil inhalations three times a week for one month, or to a control group, which will continue routine treatment and care. Data will be collected using the Hypertension Diagnostic Form, Beck Anxiety Inventory, and Pittsburgh Sleep Quality Index. Statistical analyses will be conducted to compare outcomes between the experimental and control groups.

详细描述

This study aims to evaluate the effects of lavender oil inhalation on anxiety, sleep quality, and blood pressure in patients with primary hypertension. It is designed as a double-blind randomized controlled trial. Patients presenting to the Cardiology Outpatient Clinic of Ardahan State Hospital will be recruited for the study. Participants will be randomly assigned to an experimental group, which will receive 12 lavender oil inhalations three times a week for one month, or to a control group, which will continue routine care. Data will be collected using the Hypertension Diagnostic Form, Beck Anxiety Inventory, and Pittsburgh Sleep Quality Index. The study will assess whether lavender oil inhalation affects anxiety, sleep quality, and blood pressure in this population. Statistical analyses will be conducted to compare outcomes between the experimental and control groups.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Investigator, Outcomes Assessor)

盲法说明

Participants, the interventionist, and the statistician are blinded. Patients are randomly assigned using simple randomization (odd-numbered to one group, even-numbered to the other). Group allocation (lavender oil or control) is determined by an independent nurse. Separate consent forms and coded data entry (groups as 1 and 2) ensure blinding is maintained.

入排标准

性别
All
接受健康志愿者

入选标准

  • Diagnosed with primary hypertension
  • Willing to participate in the study
  • No allergy to lavender
  • No olfactory impairments
  • No history of psychiatric disorders

排除标准

  • Communication difficulties
  • Unwilling to participate
  • Using other herbal or aromatherapy treatments
  • History of sleep disorders affecting sleep quality (e.g., obstructive sleep apnea)
  • Secondary hypertension or other chronic diseases
  • Pregnant or breastfeeding
  • Use of tobacco products

结局指标

主要结局

Anxiety

时间窗: Baseline, Week 2, Week 4

Measured using the Beck Anxiety Inventory (BAI) at baseline, week 2, and week 4. Higher scores indicate higher anxiety.

Blood Pressure

时间窗: Baseline, Week 2, Week 4

Measured using the Hypertension Diagnostic Form at baseline, week 2, and week 4. Includes systolic and diastolic measurements.

次要结局

  • Sleep quality(Baseline, Week 2, Week 4)

研究者

发起方
Ardahan University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Derya Şimşekli

Asist. Prof. Dr.

Ardahan University

研究点 (1)

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