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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05151068
Other study ID # 20210928
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 1, 2021
Est. completion date December 31, 2021

Study information

Verified date November 2021
Source The First Affiliated Hospital of Soochow University
Contact Jun Zhao
Phone 86-0512-67972216
Email zhaojia0327@126.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 200
Est. completion date December 31, 2021
Est. primary completion date December 31, 2021
Accepts healthy volunteers No
Gender All
Age group 50 Years to 70 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
traditional nursing method
?Preoperative 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. ?Pipe 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. ?Oral care: routinely brush teeth and gargle with mouthwash daily. ?Skin 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. ? Pain care: assess the degree of pain, follow the doctor's prescription for medication, and observe the efficacy of medication. ?Psychological care: pay attention to the emotional changes of patients and provide psychological support.
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.

Locations

Country Name City State
China The first affiliated hospital of soochow university Suzhou Jiangsu

Sponsors (1)

Lead Sponsor Collaborator
The First Affiliated Hospital of Soochow University

Country where clinical trial is conducted

China, 

References & Publications (8)

Fu HY, Chen QZ, Huang ZY, Wei CN. [Effect of auricular point pressing combined with electroacupuncture on postoperative pain and inflammatory cytokines in children with hernia]. Zhongguo Zhen Jiu. 2019 Jun 12;39(6):583-7. doi: 10.13703/j.0255-2930.2019.06.004. Chinese. — View Citation

Ko YL, Lin SC, Lin PC. Effect of auricular acupressure for postpartum insomnia: an uncontrolled clinical trial. J Clin Nurs. 2016 Feb;25(3-4):332-9. doi: 10.1111/jocn.13053. Epub 2015 Nov 27. — View Citation

Li L, Wang J, Li Y. [Effects of auricular plaster therapy on quality of life in uremia patients after parathyroidectomy plus autograft]. Zhongguo Zhen Jiu. 2017 Sep 12;37(9):938-43. doi: 10.13703/j.0255-2930.2017.09.007. Chinese. — View Citation

Long Q, Li Y, Li J, Wen Y, Du W, Wan C, Yue C. [Clinical observation of electroacupuncture combined with auricular point sticking therapy for anal pain of mixed hemorrhoid after external excision and internal ligation]. Zhongguo Zhen Jiu. 2018 Jun 12;38(6):580-5. doi: 10.13703/j.0255-2930.2018.06.003. Chinese. — View Citation

Sun JL, Sung MS, Huang MY, Cheng GC, Lin CC. Effectiveness of acupressure for residents of long-term care facilities with insomnia: a randomized controlled trial. Int J Nurs Stud. 2010 Jul;47(7):798-805. doi: 10.1016/j.ijnurstu.2009.12.003. Epub 2010 Jan 6. — View Citation

Wang TR, Han Y, Liu B, Du MB, Xiang YH, Du XH, Li ZX, Jiao Y. [Observation of acupoint application of gel plaster on insomnia]. Zhongguo Zhen Jiu. 2021 May 12;41(5):505-9. doi: 10.13703/j.0255-2930.20200423-0005. Chinese. — View Citation

Wang Z, Ma J, Ning L. [Clinical observation of dysphagia after cerebral infarction treated with awn-like needle at Tiantu(CV 22)]. Zhongguo Zhen Jiu. 2016 Oct 12;36(10):1019-1022. doi: 10.13703/j.0255-2930.2016.10.004. Chinese. — View Citation

Yuan J, Chen Y, Yu P, Luo F, Gao Y, Chen J, Wang P, Wang Y, Zhao Y, Lei Y. Effect of magnetic stimulation of Shenmen point on cognitive function of chronic insomnia: A randomized controlled clinical trial. Medicine (Baltimore). 2020 Dec 18;99(51):e23807. doi: 10.1097/MD.0000000000023807. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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%. Through study completion,an average of 7 days.
Primary The change of thirst 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
Primary The change of throe throat 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
Primary 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. Evaluate at admission, 24 hours, 48 hours, 72 hours and 7 days.
Primary The change of sleep 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.
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