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NCT Number: NCT07518680

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

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

Pressing the Tiantu acupoint to stimulate coughing

Other

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

Primary outcomes

  1. Cough peak expiratory flow rate at each time point

    Time frame: Baseline, during acupoint stimulation, and 30 minutes post-stimulation

    The maximum expiratory flow rate generated in the airway when coughing forcefully and rapidly. Measured by a portable peak flow meter sealed at the patient's mouth during coughing. It is a crucial and objective quantitative indicator for evaluating cough efficiency and the strength of the expiratory muscles.

Secondary outcomes

  1. Change in intra-abdominal pressure at each time point

    Time frame: Baseline, during acupoint stimulation, and 30 minutes post-stimulation

    The change in intra-abdominal pressure is the key driving force for effective coughing and can be used to assess the strength of the cough. Measured by bladder manometry, the baseline value before coughing and the peak value during coughing are recorded, and the difference is calculated to assess cough strength.

  2. Oxygen saturation at each time point

    Time frame: Baseline, during acupoint stimulation, and 30 minutes post-stimulation

    Oxygen saturation (SpO2) recorded from the bedside patient monitor. It can indirectly assess the effectiveness of the patient's coughing after Tiantu acupoint stimulation.

  3. Blood pressure at each time point

    Time frame: Baseline, during acupoint stimulation, and 30 minutes post-stimulation

    Blood pressure recorded from the bedside patient monitor. Used to assess the safety of Tiantu acupoint stimulation by comparing hemodynamic fluctuations between stimulated and unstimulated coughing.

  4. Heart rate at each time point

    Time frame: Baseline, during acupoint stimulation, and 30 minutes post-stimulation

    Heart rate recorded from the bedside patient monitor. Used to assess the safety of Tiantu acupoint stimulation by comparing heart rate fluctuations between stimulated and unstimulated coughing.

Study contacts

Contact information is provided by the study sponsor or research team.

Minjie Ju, ScD

CONTACT

[email protected]

19180861785

Sponsors and collaborators

Lead sponsor

Shanghai Zhongshan Hospital

Other

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Apr 8, 2026
Registry last updated
Apr 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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