A Clinical Study on the Effect of Massaging Tian Tu Acupoint on Coughing After Esophageal Surgery

Обзор

This study is a single-center, self-controlled trial. Patients will successively undergo voluntary coughing without intervention, a washout period, coughing stimulated by pressing the Tiantu acupoint, a washout period, and voluntary coughing without intervention. Vital signs of the patients before and after each cough will be recorded, as well as the changes in peak cough flow rate and intra-abdominal pressure after each cough. For peak cough flow rate and intra-abdominal pressure, three sets of data will be collected each time, and the best value will be taken. This pilot trial is conducted to verify the feasibility of the research design and to provide sample size estimation and data support for the main study.

Подробное описание

This study is a single-center, self-controlled trial. Patients will successively undergo voluntary coughing without intervention, a washout period, coughing stimulated by pressing the Tiantu acupoint, another washout period, and voluntary coughing without intervention. Vital signs of the patients before and after each cough will be recorded, as well as the changes in peak cough flow rate and intra-abdominal pressure after each cough. Three sets of data will be collected for peak cough flow rate and intra-abdominal pressure each time, and the best value will be taken. The force, angle, and method of pressing are all specified with specific values. The finger pressure is measured by a pressure gauge at 1.59 to 3.45 N, each press lasts for 4 seconds, with an interval of 5 minutes, and is repeated three times. This pilot trial is conducted to verify the feasibility of the research design and provide sample size estimation and data support for the main study. It mainly focuses on patients after esophageal surgery to investigate whether pressing the Tiantu acupoint can effectively improve the coughing ability of patients.

Вмешательства

• Другое Pressing the Tiantu acupoint to stimulate coughing
  At the end of inhalation, press the Tiantu acupoint to stimulate coughing. The specific operation method has been mentioned earlier.

Первичные конечные точки

• Cough peak expiratory flow rate at each time point [Срок оценки: Baseline, during acupoint stimulation, and 30 minutes post-stimulation]

Вторичные конечные точки (4)

• Change in intra-abdominal pressure at each time point [Срок оценки: Baseline, during acupoint stimulation, and 30 minutes post-stimulation]
• Oxygen saturation at each time point [Срок оценки: Baseline, during acupoint stimulation, and 30 minutes post-stimulation]
• Blood pressure at each time point [Срок оценки: Baseline, during acupoint stimulation, and 30 minutes post-stimulation]
• Heart rate at each time point [Срок оценки: Baseline, during acupoint stimulation, and 30 minutes post-stimulation]

Критерии участия

Критерии включения

• Voluntarily sign the informed consent form and follow the requirements of the protocol;
• Age 18 to 75 years old (inclusive), gender not limited;
• Patients who have undergone esophageal surgery (without intubation);
• Not taking psychotropic drugs, mentally sound, and likely to cooperate in completing the assessment and intervention.

Критерии исключения

• The subjects or their family members request to withdraw from the study;
• Pregnancy or lactation period;
• Severe heart and lung diseases (such as heart failure, acute exacerbation of COPD, asthma, etc.);
• Skin damage or infection in the area of the Tiantu acupoint;
• Within the last month, have received other cough-related interventions (such as acupuncture, physical therapy);
• Other situations that the researcher deems unsuitable for participating in this clinical trial

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Zhongshan Hospital — Шанхай

Идентификаторы

NCT: NCT07518680 · B2025-455R

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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