NCT05151068

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2021

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

October 21, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 9, 2021

Completed
22 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

December 9, 2021

Status Verified

November 1, 2021

Enrollment Period

12 months

First QC Date

October 21, 2021

Last Update Submit

November 25, 2021

Conditions

Keywords

acupoint applicationear acupoint embeddingesophageal cancer surgeryunplanned extubationthirstthore throatcomfortsleep

Outcome Measures

Primary Outcomes (5)

  • 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.

  • 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

  • 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

  • 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.

  • 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.

Study Arms (2)

Group A,traditional

EXPERIMENTAL

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

Group B,Precise

EXPERIMENTAL

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

Interventions

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.

Group A,traditional

On the basis of conventional nursing, the experimental group adopted a precision nursing program of acupoint application combined with ear acupoint embedding.

Group B,Precise

Eligibility Criteria

Age50 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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 .

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The first affiliated hospital of soochow university

Suzhou, Jiangsu, 215000, China

RECRUITING

Related Publications (8)

  • 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.

    PMID: 34002563BACKGROUND
  • 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.

    PMID: 33371157BACKGROUND
  • 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.

    PMID: 26612319BACKGROUND
  • 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.

    PMID: 20056221BACKGROUND
  • 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.

    PMID: 31190492BACKGROUND
  • 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.

    PMID: 29971998BACKGROUND
  • 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.

    PMID: 29354913BACKGROUND
  • 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.

    PMID: 29231518BACKGROUND

Study Officials

  • Jing Luo

    The First Affiliated Hospital of Soochow University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 21, 2021

First Posted

December 9, 2021

Study Start

January 1, 2021

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

December 9, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share

Locations