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Nursing effect of ear-point pressing beans combined with ear-cube-stone scraping during postoperative nasal cavity filling in patients with chronic sinusitis

Registration number：

ITMCTR2200006766

Date of Last Refreshed on：

2022-11-11

Date of Registration：

2022-11-11

Registration Status：

Prospective registration

Public title：

Nursing effect of ear-point pressing beans combined with ear-cube-stone scraping during postoperative nasal cavity filling in patients with chronic sinusitis

English Acronym：

Scientific title：

Nursing effect of ear-point pressing beans combined with ear-cube-stone scraping during postoperative nasal cavity filling in patients with chronic sinusitis

Scientific title acronym：

Study subject ID：

The registration number of the Partner Registry or other register：

ChiCTR2200065660 ; ChiMCTR2200006766

Applicant：

AiChun Zeng

Study leader：

AiChun Zeng

Applicant telephone：

18973489989

Study leader's telephone：

18973489989

Applicant Fax：

Study leader's fax：

Applicant E-mail：

aihu20@sina.com

Study leader's E-mail：

aihu20@sina.com

Study leader's website(voluntary supply)：

Study leader's website
(voluntary supply)：

Applicant address：

69 Chuanshan Road,Shigu District,Hengyang City,Hunan Province

Study leader's address：

69 Chuanshan Road,Shigu District,Hengyang City,Hunan Province

Applicant postcode：

Study leader's postcode：

Applicant's institution：

The First Affiliated Hospital,Hengyang Medical School, University of South China

Approved by ethic committee：

Approved No. of ethic committee：

2022ll1103001

Approved file of Ethical Committee：

View

Name of the ethic committee：

Medical Ethics Committee of The First Affiliated Hospital,Hengyang Medical School, University of South

Date of approved by ethic committee：

2022/11/3 0:00:00

Contact Name of the ethic committee：

Contact Address of the ethic committee：

Contact phone of the ethic committee：

Contact email of the ethic committee：

Primary sponsor：

The First Affiliated Hospital,Hengyang Medical School, University of South China

Primary sponsor's address：

69 Chuanshan Road,Shigu District,Hengyang City,Hunan Province

Secondary sponsor：

Country：

China

Province：

Hunan Province

City：

Institution
hospital：

The First Affiliated Hospital,Hengyang Medical School, University of South China

Address：

69 Chuanshan Road,Shigu District,Hengyang City,Hunan Province

Source(s) of funding：

Special Financial Funds of Hunan Provincial Health Commission and Self-financing

Target disease：

Chronic sinusitis

Target disease code：

Study type：

Interventional study

Study design：

Randomly Sampling

Study phase：

Pilot clinical trial

Objectives of Study：

To explore the effect of nursing intervention program of auricular point pressing bean combined with ear copper-point scraping on pain, comfort, sleep quality and nasal bleeding of patients with chronic sinusitis after operation.

Description for medicine or protocol of treatment in detail：

Inclusion criteria

(1) Age: 18-60 years old; (2) Those who meet the diagnostic criteria of chronic sinusitis in the Guidelines for the Diagnosis and Treatment of Chronic Sinusitis formulated by the Rhinology Group of the Editorial Committee of the Chinese Journal of Otorhinolaryngology Head and Neck Surgery; (3) Bilateral endoscopic sinus fenestration under general anesthesia and nasal packing after operation; (4) If the operation time is less than 3 hours; (5) Sign the informed consent form and voluntarily participate in the study.

Exclusion criteria：

(1) Caregivers who have been treated with traditional Chinese medicine for nearly one week before the operation; (2) people with mental retardation or cognitive dysfunction who cannot match (mental disorders, senile dementia, etc.) or those who are pregnant and lactating; (3) Other serious chronic diseases or malignant tumors; (4) Long-term use of analgesics or long-term sleep disorders; (5) A rash or local infection occurs in the skin area of selected acupuncture points in the ear.

Study execute time：

From 2022-01-01

To      2024-12-31

Recruiting time：

From 2023-01-01

To      2023-12-31

Interventions：

40

Group：

the ear tongbian scraping group

Sample size：

Intervention：

the care of ear Tongbian scraping plus routine nursing

Intervention code：

40

Group：

the control group

Sample size：

Intervention：

routine nursing for nasal surgery after operation

Intervention code：

40

Group：

the ear acupoint bean pressing group

Sample size：

Intervention：

the care of ear acupoint bean pressing plus routine nursing

Intervention code：

40

Group：

the ear tongbian scraping combined with ear acupoint bean pressing group

Sample size：

Intervention：

the care of ear Tongbian scraping and ear acupoint bean pressing plus routine nursing

Intervention code：

Total sample size ： 160

Countries of recruitment
and research settings：

Country：

China

Province：

Hunan Province

City：

Institution/hospital：

The First Affiliated Hospital,Hengyang Medical School, University of South China

Level of the institution：

A tertiary hospital

Outcomes：

Outcome：

Sleep quality

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

Degree of pain

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Nasal hemorrhage

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

comfort

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Collecting sample(s)
from participants：

Sample Name：

Blood

Tissue：

Fate of sample 

Destruction after use

Note：

Recruiting

Min age years
Max age years

Recruiting status：

Participant age：

Gender：

Both

Randomization Procedure (please state who generates the random number sequence and by what method)：

Random sequences were generated by the study principal through SPSS26.0 statistical software.

Blinding：

IPD sharing：

No

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

Not yet certain

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：

Random sequences were generated by the study principal through SPSS26.0 statistical software.

Data Managemen Committee：

Publication information of the protocol/research results report
(name of the journal, volume, issue, pages, time; or website):

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