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

N

National Taipei University of Nursing and Health Sciences

Status

Not yet enrolling

Conditions

Pulmonary Infections
Type 2 Diabetes Mellitus (T2DM)
Pneumonia

Treatments

Combination Product: Essential Oil Diffusion Combined with Respiratory Training

Study type

Interventional

Funder types

Other

Identifiers

NCT07103460
B2023051651

Details and patient eligibility

About

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,

Enrollment

100 estimated patients

Sex

All

Ages

18 to 90 years old

Volunteers

No Healthy Volunteers

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).

Trial design

Primary purpose

Supportive Care

Allocation

N/A

Interventional model

Sequential Assignment

Masking

None (Open label)

100 participants in 1 patient group

treatment group
Experimental group
Treatment:
Combination Product: Essential Oil Diffusion Combined with Respiratory Training

Trial contacts and locations

1

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Central trial contact

Yu-Shan Hsieh

Data sourced from clinicaltrials.gov

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