The Impact of Comprehensive Education Before Gastroscopy on Improving the Tolerance of Patients

NCT ID: NCT03638752

Last Updated: 2019-07-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

260 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-15

Study Completion Date

2018-09-15

Brief Summary

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This clinical trial is being conducted to assess whether the comprehensive education before gastroscopy could reduce the adverse reactions, such as nausea, vomiting and improve patient satisfaction.

Detailed Description

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Conditions

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Comprehensive Education

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Caregivers Investigators
The endoscopist and endoscopy nurse will not know to which treatment arm the patient belongs as only the research assistant will has taken down this information. This information does not travel with the patient to the endoscopy room. The patient is also instructed to not reveal to the endoscopist or endoscopy nurse if he or she has taken or not taken the comprehensive education.

Study Groups

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Comprehensive education group

The details of Comprehensive education are as follows:

1. introduce the purpose, method and function of breathing training and the whole process of gastroscopy;
2. instruct patients to take deep breath training, inhaling with his/her nose and exhaling with his/her mouth,
3. provide patients with a disposable dental biting device and repeat exercising deep breathing again until he/she is fully mastered,
4. inform patients to cooperate with the instructions issued by endoscopist and endoscopy nurse during the whole process of gastroscopy,
5. inform patients to inhale with nose and exhale with mouth when the gastroscope passes through the throat, then he/she should perform inhaling and exhaling with his/her nose until the end of the gastroscopy when the endoscopist ask to adjust the breathing method,
6. inform patients that there would be some normal physiological reaction when gastroscopy, such as throat discomfort and nausea/vomiting.

Group Type EXPERIMENTAL

Comprehensive education group

Intervention Type OTHER

The details of Comprehensive education are as follows:

1. introduce the purpose, method and function of breathing training and the whole process of gastroscopy;
2. instruct patients to take deep breath training, inhaling with his/her nose and exhaling with his/her mouth,
3. provide patients with a disposable dental biting device and repeat exercising deep breathing again until he/she is fully mastered,
4. inform patients to cooperate with the instructions issued by endoscopist and endoscopy nurse during the whole process of gastroscopy,
5. inform patients to inhale with nose and exhale with mouth when the gastroscope passes through the throat, then he/she should perform inhaling and exhaling with his/her nose until the end of the gastroscopy when the endoscopist ask to adjust the breathing method,
6. inform patients that there would be some normal physiological reaction when gastroscopy, such as throat discomfort and nausea/vomiting.

standard education

The details of standard education are as follows:

1. inform patients to cooperate with the instructions issued by endoscopist and endoscopy nurse during the whole process of gastroscopy,
2. inform patients that there would be some normal physiological reaction when gastroscopy, such as the throat discomfort and nausea/vomiting.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Comprehensive education group

The details of Comprehensive education are as follows:

1. introduce the purpose, method and function of breathing training and the whole process of gastroscopy;
2. instruct patients to take deep breath training, inhaling with his/her nose and exhaling with his/her mouth,
3. provide patients with a disposable dental biting device and repeat exercising deep breathing again until he/she is fully mastered,
4. inform patients to cooperate with the instructions issued by endoscopist and endoscopy nurse during the whole process of gastroscopy,
5. inform patients to inhale with nose and exhale with mouth when the gastroscope passes through the throat, then he/she should perform inhaling and exhaling with his/her nose until the end of the gastroscopy when the endoscopist ask to adjust the breathing method,
6. inform patients that there would be some normal physiological reaction when gastroscopy, such as throat discomfort and nausea/vomiting.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Patients over the age of 18 years undergoing routine gastroscopy
2. Informed consent

Exclusion Criteria

1. Serious coronary heart disease and myocardial injury with serious heart failure
2. Stenosis of the esophagus or cardia obstruction
3. Acute pharyngitis and tonsillitis
4. Acute upper gastrointestinal bleeding
5. Hemodynamically unstable
6. allergy to topical lidocaine
7. Patients did not cooperate or spirit was not normal
8. Pregnancy
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ningbo No. 1 Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lei Xu, PHD

Role: PRINCIPAL_INVESTIGATOR

Department of Gastroenterology, Ningbo No. 1 Hospital, Ningbo, China

Locations

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Ningbo NO.1 hospital

Ningbo, Zhejiang, China

Site Status

Countries

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China

Other Identifiers

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2018-R010

Identifier Type: -

Identifier Source: org_study_id

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