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The effect of symptom improvement of nasal steam strategy compared to routine management strategy for upper respiratory symptoms occurring after endotracheal intubation in patients aged 19 years or older who underwent surgical removal under anesthesia requiring endotracheal intubation was evaluated by the difference in the results of Wisconsin Upper Respiratory Symptom Survey
This study aims to confirm the comparative effectiveness of nasal steam therapy by conducting a practical randomized controlled clinical trial comparing 66 patients complaining of upper respiratory symptoms with patients treated with a nasal steam therapy strategy (33 patients) and patients treated with a routine management strategy (33 patients).
This study is a practical clinical study, and only randomly assigns patients to two groups: nasal steam therapy strategy and routine management strategy. The specific treatment method used is not determined in advance. The specific treatment is performed according to the clinical judgment according to the patient's condition. All treatment methods used during the study are recorded in the case report and compared.
The treatment will be administered for a total of 5 days, and drug treatment may not be discontinued after the study period at the clinician's discretion.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nasal Steam therapy strategy | Experimental | Nasal steam therapy is performed once a every other day for a total of 3three times. The steam inhalation stimulates the acupoints of bilateral LI20, EX-HN8, and EX-HN9 |
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| Routine management strategy | Active Comparator | This study is a practical clinical study, and the selection of drugs and other treatment methods will be based on the doctor's clinical judgment regarding the patient's symptoms, degree of improvement, etc. Drug administration or patient education will be implemented according to symptoms. Depending on the patient's symptoms and degree of improvement, the clinician may utilize all drugs currently used in clinical practice to improve upper respiratory symptoms, if necessary. All drugs that fall under the Anatomical Therapeutic Chemical Classification System (ATC) codes of non-disease treatment (R01), throat disease treatment (R02), lung disease or expectorant (R03, R05), and other respiratory organ drugs (R06, R07) and other drugs that clinicians orally administer in current clinical practice for the purpose of improving upper respiratory symptoms will be collected. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nasal steam therapy | Procedure | Nasal steam therapy is performed once a every other day for a total of 3three times. The steam inhalation stimulates the acupoints of bilateral LI20, EX-HN8, and EX-HN9 |
| Measure | Description | Time Frame |
|---|---|---|
| Wisconsin upper respiratory symptom survey-24, WURSS-24 | WURSS is a questionnaire mainly used to evaluate symptoms of acute upper respiratory tract infection, and is divided into WURSS-11, WURSS-21, WURSS-24, WURSS-44, and WURSS-Kids versions. In this study, WURSS-24 will be used to evaluate the degree of daily symptom improvement by dividing it into items of symptoms, quality of life, and overall satisfaction, and 24 questions on a 7-point Likert scale. The most severe level is evaluated as 7 points, the least level as 1 point, and in the case of symptoms and quality of life that may be lost, 0 points are additionally recorded when the symptoms are lost. | From enrollment to the end of treatment at Day 8, and follow up visit at Day 15 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and severity of cough |
|
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Inclusion Criteria:
Age of 19 to 69 years
Those who underwent surgical removal of the thyroid gland under endotracheal intubation due to a thyroid tumor
American Society of Anesthesiologists (ASA) status I or II
Exclusion criteria:
Those diagnosed with symptomatic gastroesophageal reflux disease
Chronic cough lasting for more than 3 months prior to surgery, including bronchial asthma and chronic obstructive pulmonary disease (COPD)
Those who developed other respiratory infections within the past month â‘£ Those who are taking or are required to take other medications that may interfere with the interpretation of the treatment effect or results
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jee Young Lee, MD(KMD), PhD | Contact | 082-31-782-3113 | happiade@chamc.co.kr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ilsan Cha Hospital | Recruiting | Goyang-si | Gyeonggi-do | 082-10414 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40955847 | Derived | Hong SE, Hyun MH, Lee SH, Kim BW, Kim HJ, Ko EJ, Lee JY. Effectiveness and Safety of Nasal Herbal Steam Therapy for Post-Extubation Respiratory Symptoms: A Methodology of Pragmatic Randomized Controlled, Parallel Grouped Study. Integr Cancer Ther. 2025 Jan-Dec;24:15347354251375469. doi: 10.1177/15347354251375469. Epub 2025 Sep 16. |
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This study is part of a national project and data will be provided based on the decision of the Korea Health Industry Development Institute under the Ministry of Health and Welfare.
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| ID | Term |
|---|---|
| D013964 | Thyroid Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
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Nasal steam therapy is performed once a every other day for a total of 3three times. The steam inhalation stimulates the acupoints of bilateral LI20, EX-HN8, and EX-HN9
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The outcome assessor and the statistician will be blinded to evaluate the efficacy.
| Routine management strategy | Procedure | Depending on the patient's symptoms and degree of improvement, the clinician may utilize all drugs currently used in clinical practice to improve upper respiratory symptoms, if necessary. All drugs that fall under the Anatomical Therapeutic Chemical Classification System (ATC) codes of non-disease treatment (R01), throat disease treatment (R02), lung disease or expectorant (R03, R05), and other respiratory organ drugs (R06, R07) and other drugs. The usage and dosage should be within the range of the current clinical guidelines. |
|
| Day 1, Day 4, Day 8, Day 15 |
| Thyroid cancer-Quality of Life (ThyCa-QoL) | - THYCA-QoL is a health-related quality of life questionnaire developed for thyroid cancer and thyroid cancer survivors. It was developed using methodologically proven standard guidelines and is a validated questionnaire that can improve symptoms, treatment, aftercare, and disease experience of thyroid cancer survivors. | Day 1, Day 4, Day 8, Day 15 |
| D004700 |
| Endocrine System Diseases |
| D013959 | Thyroid Diseases |