Essential Oil-Assisted Respiratory Training in Type 2 Diabetic Patients With Lung Infections
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Essential Oil Diffusion Combined with Respiratory Training.
- Who it may be relevant to
- Registry conditions: Type 2 Diabetes Mellitus (T2DM), Pulmonary Infections, Pneumonia. Basic parameters: 18 years — 90 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Taiwan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Effect of Essential Oil Diffusion Combined With Respiratory Training on the Respiratory Function of Patients With Acute Pulmonary Infections and Type 2 Diabetes
Overview
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,
Interventions
- Combination product Essential Oil Diffusion Combined with Respiratory Training
three commonly used essential oils (wintergreen, peppermint, and eucalyptus) will be integrated into IS respiratory training
Primary outcome measures
- fasting sugar (mg/dl) [Time frame: baseline(admission), pre-intervention (1-24hrs, before intervention) and post-intervention (1-24hrs, after intervention)]
- Glycated Hemoglobin; HbA1c (%) [Time frame: baseline(admission), pre-intervention (1-24hrs, before intervention) and post-intervention (1-24hrs, after intervention)]
- Oxyhemoglobin saturation by pulse oximetry; SpO2 (%) [Time frame: baseline(admission), pre-intervention (1-24hrs, before intervention) and post-intervention (1-24hrs, after intervention)]
- Hemoglobin; Hb(g/dL) [Time frame: baseline(admission), pre-intervention (1-24hrs, before intervention) and post-intervention (1-24hrs, after intervention)]
- lactate(mmol/L) [Time frame: baseline(admission), pre-intervention (1-24hrs, before intervention) and post-intervention (1-24hrs, after intervention)]
- Dyspnea-12 score; D-12 [Time frame: baseline(admission), pre-intervention (1-24hrs, before intervention) and post-intervention (1-24hrs, after intervention)]
- Pulmonary function test-PEF (peak expiratory flow)(L/min) [Time frame: 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) [Time frame: baseline(admission), pre-intervention (1-24hrs, before intervention) and post-intervention (1-24hrs, after intervention)]
Eligibility criteria
Inclusion criteria
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.
Exclusion criteria
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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
Taiwan · 1 center
- Tri-Service General Hospital Songshan Branch — Taipei
Identifiers
NCT: NCT07103460 · B2023051651