Essential Oil-Assisted Respiratory Training in Type 2 Diabetic Patients With Lung Infections

Официальное название

The Effect of Essential Oil Diffusion Combined With Respiratory Training on the Respiratory Function of Patients With Acute Pulmonary Infections and Type 2 Diabetes

Обзор

Previous studies have shown that baseline pulmonary function in patients with type 2 diabetes mellitus (T2DM) is approximately 8% to 10% lower than in healthy individuals. Under similar infection conditions, respiratory function impairment is more pronounced in T2DM patients. Therefore, this project aims to explore the effects of incentive spirometry (IS) respiratory training combined with an essential oil diffusion device on improving respiratory function in T2DM patients. Over next two years, this study will utilize data from medical history, blood examination, cardiopulmonary endurance evaluations, subjective respiratory symptom assessments, and pulmonary function analyses to demonstrate the improving effect of the intervention in the patients with T2DM and pulmonary infection. In the first year, the study will focus on assessing the improvement in respiratory function among T2DM patients with concurrent pulmonary infections following IS respiratory training. In the second year, three commonly used essential oils (wintergreen, peppermint, and eucalyptus) will be integrated into IS respiratory training. The goal is to enhance patient comfort during training while improving the effectiveness of respiratory training and investigating the mechanisms and effects of different essential oils. The expected outcomes of this study include demonstrating that IS respiratory training combined with an essential oil diffusion device developed by our research team, could more effectively improve the respiratory function of T2DM patients with pulmonary infections. Building on this foundation, the project aims to increase patient comfort during training sessions by incorporating three commonly available essential oils-wintergreen, peppermint, and eucalyptus. This approach is expected to enhance patient acceptance of respiratory training interventions, laying a solid foundation for clinical promotion. Additionally, the study will analyze the differential effects of these essential oils on respiratory function improvement, providing a cornerstone for future clinical research in the fields of chemistry,

Вмешательства

• Комбинированный продукт Essential Oil Diffusion Combined with Respiratory Training
  three commonly used essential oils (wintergreen, peppermint, and eucalyptus) will be integrated into IS respiratory training

Первичные конечные точки

• fasting sugar (mg/dl) [Срок оценки: baseline(admission), pre-intervention (1-24hrs, before intervention) and post-intervention (1-24hrs, after intervention)]
• Glycated Hemoglobin; HbA1c (%) [Срок оценки: baseline(admission), pre-intervention (1-24hrs, before intervention) and post-intervention (1-24hrs, after intervention)]
• Oxyhemoglobin saturation by pulse oximetry; SpO2 (%) [Срок оценки: baseline(admission), pre-intervention (1-24hrs, before intervention) and post-intervention (1-24hrs, after intervention)]
• Hemoglobin; Hb(g/dL) [Срок оценки: baseline(admission), pre-intervention (1-24hrs, before intervention) and post-intervention (1-24hrs, after intervention)]
• lactate(mmol/L) [Срок оценки: baseline(admission), pre-intervention (1-24hrs, before intervention) and post-intervention (1-24hrs, after intervention)]
• Dyspnea-12 score; D-12 [Срок оценки: baseline(admission), pre-intervention (1-24hrs, before intervention) and post-intervention (1-24hrs, after intervention)]
• Pulmonary function test-PEF (peak expiratory flow)(L/min) [Срок оценки: baseline(admission), pre-intervention (1-24hrs, before intervention) and post-intervention (1-24hrs, after intervention)]
• lung function test- FEV1(Forced expiratory volume in the first second ) (L) [Срок оценки: baseline(admission), pre-intervention (1-24hrs, before intervention) and post-intervention (1-24hrs, after intervention)]

Критерии участия

Критерии включения

I. Currently hospitalized due to pulmonary infection (ICD-10 codes: J00.x to J22.x).

II. Diagnosed with type 2 diabetes mellitus (ICD-10 codes: E10.x or E11.x). III. Aged between 18 and 90 years. IV. Able to communicate verbally or non-verbally and understand Mandarin or Taiwanese.

V. Willing to participate in the study and consent to group assignment.

Критерии исключения

I. Modified Rankin Scale (mRS) score ≥ 5, indicating severe functional impairment.

II. Diagnosed with dementia (unable to comprehend or follow intervention instructions).

III. Presence of acute psychiatric symptoms that impair communication. IV. Individuals with high litigation risk. V. Diagnosed with chronic obstructive pulmonary disease (COPD) or any other chronic respiratory diseases.

VI. Diagnosed with glucose-6-phosphate dehydrogenase (G6PD) deficiency (ICD-10 codes: D55.x, D74-75.x).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Последовательный дизайн

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Тайвань · 1 центр

• Tri-Service General Hospital Songshan Branch — Taipei

Идентификаторы

NCT: NCT07103460 · B2023051651

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗