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Not yet recruiting NCT07518680

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

No phase Interventional Esophageal Neoplasms

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: Pressing the Tiantu acupoint to stimulate coughing.
Who it may be relevant to
Registry conditions: Esophageal Neoplasms. Basic parameters: 18 years — 75 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
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Detailed description

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.

Interventions

  • Other 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.

Primary outcome measures

  • Cough peak expiratory flow rate at each time point [Time frame: Baseline, during acupoint stimulation, and 30 minutes post-stimulation]
Secondary outcome measures (4)
  • Change in intra-abdominal pressure at each time point [Time frame: Baseline, during acupoint stimulation, and 30 minutes post-stimulation]
  • Oxygen saturation at each time point [Time frame: Baseline, during acupoint stimulation, and 30 minutes post-stimulation]
  • Blood pressure at each time point [Time frame: Baseline, during acupoint stimulation, and 30 minutes post-stimulation]
  • Heart rate at each time point [Time frame: Baseline, during acupoint stimulation, and 30 minutes post-stimulation]

Eligibility criteria

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

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
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Zhongshan Hospital — Shanghai

Identifiers

NCT: NCT07518680 · B2025-455R

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗