the Effect of Acupoint Application Combined With Ear Acupoint Embedding in Patients After Esophageal Cancer Surgery

November 25, 2021 updated by: The First Affiliated Hospital of Soochow University

Study on the Effect of Acupoint Application Combined With Ear Acupoint Embedding on the Discomfort Symptoms of Nasal Catheterization in Patients After Esophageal Cancer Surgery

To study the effect of acupoint application combined with ear acupoint seeding on the discomfort symptoms of nasal catheter in patients after esophageal cancer surgery

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

From January to December 2021, 200 patients after esophageal cancer surgery with nasal catherterization in an affiliated hospital of Soochow will be selected as the research objects, and they will be divided into experimental group (100 cases) and control group (100 cases) by random number table method. The control group will receive routine nursing care, and the experimental group will implement a precision nursing program of acupoint application combined with ear acupoint embedding on the basis of the control group. The thirst, throat pain, comfort, sleep, and unplanned extubation rate will be compared between the two groups.

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Jiangsu
      • Suzhou, Jiangsu, China, 215000
        • Recruiting
        • The First Affiliated Hospital of Soochow University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Meet the diagnostic criteria for esophageal cancer; Age 50-70 years old; Undertake radical surgery for esophageal cancer, and place a tube through the nose after surgery; The patient communicates well with no cognitive impairment; Informed consent for this study, signed informed consent .

Exclusion Criteria:

Patients undergoing mechanical ventilation after surgery; Serious complications and death after surgery; Patients with external ear diseases and skin damage; Participating in other clinical research projects.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A,traditional
The control group is given conventional nursing care: ①Preoperative education, informing patients of the importance of the tube and the adverse effects of unauthorised extubation after the operation on the recovery of the disease. ②Pipe care: The nose wing is fixed with modified "human" elastic tape, and the same side cheek bridge is fixed to keep the duct unobstructed and pour gastric juice in time. ③Oral care: routinely brush teeth and gargle with mouthwash daily. ④Skin care: Observe the condition of the nose, cheek skin and oral and nasal mucosa. Replace the tape as needed, and clean the skin before fixing. ⑤ Pain care: assess the degree of pain, follow the doctor's prescription for medication, and observe the efficacy of medication. ⑥Psychological care: pay attention to the emotional changes of patients and provide psychological support.This group is planned to enroll 100 patients.
Behavioral: traditional nursing method
①Preoperative education, informing patients of the importance of the tube and the adverse effects of unauthorised extubation after the operation on the recovery of the disease. ②Pipe care: The nose wing is fixed with modified "human" elastic tape, and the same side cheek bridge is fixed to keep the duct unobstructed and pour gastric juice in time. ③Oral care: routinely brush teeth and gargle with mouthwash daily. ④Skin care: Observe the condition of the nose, cheek skin and oral and nasal mucosa. Replace the tape as needed, and clean the skin before fixing. ⑤ Pain care: assess the degree of pain, follow the doctor's prescription for medication, and observe the efficacy of medication. ⑥Psychological care: pay attention to the emotional changes of patients and provide psychological support.
Experimental: Group B,Precise
On the basis of conventional nursing, the experimental group adopted a precision nursing program of acupoint application combined with ear acupoint embedding.This group is planned to enroll 100 patients.
Behavioral: Precise acupoint application combined with ear acupoint embedding nursing program
On the basis of conventional nursing, the experimental group adopted a precision nursing program of acupoint application combined with ear acupoint embedding.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
unplanned extubation
Time Frame: Through study completion,an average of 7 days.
Unplanned extubation refers to the early withdrawal of the catheter due to various reasons before the end of the treatment. This study includes the partial or complete extubation of the patient during the catheterization period. The calculation formula: (The number of cases of unplanned extubation in the group/the number of patients in the same group during the same period) × 100%.
Through study completion,an average of 7 days.
The change of thirst
Time Frame: Evaluate at 12 hours, 24 hours, 48 hours, 72 hours and 7 days after surgery
Thirst is assessed by the Visual Analogue Scale (VAS), and the higher the score, the more severe the patients' thirst .
Evaluate at 12 hours, 24 hours, 48 hours, 72 hours and 7 days after surgery
The change of throe throat
Time Frame: Evaluate at 12 hours, 24 hours, 48 hours, 72 hours and 7 days after surgery
Thore throat is evaluated by NRS. The higher the score, the more severe the throat pain of the patient.
Evaluate at 12 hours, 24 hours, 48 hours, 72 hours and 7 days after surgery
The change of comfort
Time Frame: Evaluate at admission, 24 hours, 48 hours, 72 hours and 7 days.
The comfort state is evaluated by Gnneral comfort questionnaire(GCQ). The scale includes 4 dimensions of physiology, psychology, spirit, social culture and environment, with a total of 28 items. The higher the score, the better the patient's comfort state.
Evaluate at admission, 24 hours, 48 hours, 72 hours and 7 days.
The change of sleep
Time Frame: Evaluate at admission, 24 hours, 48 hours, 72 hours and 7 days.
Sleep is evaluated using Athens insomnia scale (AIS). The higher the score, the worse the quality of sleep.
Evaluate at admission, 24 hours, 48 hours, 72 hours and 7 days.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The First Affiliated Hospital of Soochow University

Investigators

  • Principal Investigator: Jing Luo, The First Affiliated Hospital of Soochow University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2021

Primary Completion (Anticipated)

December 31, 2021

Study Completion (Anticipated)

December 31, 2021

Study Registration Dates

First Submitted

October 21, 2021

First Submitted That Met QC Criteria

November 25, 2021

First Posted (Actual)

December 9, 2021

Study Record Updates

Last Update Posted (Actual)

December 9, 2021

Last Update Submitted That Met QC Criteria

November 25, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20210928

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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