Back to resultsthe Effect of Acupoint Application Combined With Ear Acupoint Embedding in Patients After Esophageal Cancer Surgery
Primary Purpose
Traditional Chinese Medicine
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
traditional nursing method
Precise acupoint application combined with ear acupoint embedding nursing program
Sponsored by
About this trial
This is an interventional treatment trial for Traditional Chinese Medicine focused on measuring acupoint application, ear acupoint embedding, esophageal cancer surgery, unplanned extubation, thirst, thore throat, comfort, sleep
Eligibility Criteria
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.
Sites / Locations
- The first affiliated hospital of soochow universityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Group A,traditional
Group B,Precise
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
unplanned extubation
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%.
The change of thirst
Thirst is assessed by the Visual Analogue Scale (VAS), and the higher the score, the more severe the patients' thirst .
The change of throe throat
Thore throat is evaluated by NRS. The higher the score, the more severe the throat pain of the patient.
The change of comfort
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.
The change of sleep
Sleep is evaluated using Athens insomnia scale (AIS). The higher the score, the worse the quality of sleep.
Secondary Outcome Measures
Full Information
NCT ID
NCT05151068
First Posted
October 21, 2021
Last Updated
November 25, 2021
Sponsor
The First Affiliated Hospital of Soochow University
1. Study Identification
Unique Protocol Identification Number
NCT05151068
Brief Title
the Effect of Acupoint Application Combined With Ear Acupoint Embedding in Patients After Esophageal Cancer Surgery
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
December 31, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The First Affiliated Hospital of Soochow University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traditional Chinese Medicine
Keywords
acupoint application, ear acupoint embedding, esophageal cancer surgery, unplanned extubation, thirst, thore throat, comfort, sleep
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group A,traditional
Arm Type
Experimental
Arm Description
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.
Arm Title
Group B,Precise
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
traditional nursing method
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Precise acupoint application combined with ear acupoint embedding nursing program
Intervention Description
On the basis of conventional nursing, the experimental group adopted a precision nursing program of acupoint application combined with ear acupoint embedding.
Primary Outcome Measure Information:
Title
unplanned extubation
Description
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%.
Time Frame
Through study completion,an average of 7 days.
Title
The change of thirst
Description
Thirst is assessed by the Visual Analogue Scale (VAS), and the higher the score, the more severe the patients' thirst .
Time Frame
Evaluate at 12 hours, 24 hours, 48 hours, 72 hours and 7 days after surgery
Title
The change of throe throat
Description
Thore throat is evaluated by NRS. The higher the score, the more severe the throat pain of the patient.
Time Frame
Evaluate at 12 hours, 24 hours, 48 hours, 72 hours and 7 days after surgery
Title
The change of comfort
Description
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.
Time Frame
Evaluate at admission, 24 hours, 48 hours, 72 hours and 7 days.
Title
The change of sleep
Description
Sleep is evaluated using Athens insomnia scale (AIS). The higher the score, the worse the quality of sleep.
Time Frame
Evaluate at admission, 24 hours, 48 hours, 72 hours and 7 days.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jun Zhao
Phone
86-0512-67972216
Email
zhaojia0327@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jing Luo
Organizational Affiliation
The First Affiliated Hospital of Soochow University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The first affiliated hospital of soochow university
City
Suzhou
State/Province
Jiangsu
ZIP/Postal Code
215000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jun Zhao
Phone
86-0512-67972216
Email
zhaojia0327@126.com
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
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