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

The Impact of Comprehensive Education Before Gastroscopy on Improving the Tolerance of Patients: A Prospective Randomized Controlled Study

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.

Study Overview

• Status: Completed
• Conditions: Comprehensive Education
• Intervention / Treatment: Other: Comprehensive education group

• Study Type: Interventional
• Enrollment (Actual): 260
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Ningbo, Zhejiang, China, 315010
      • Ningbo NO.1 hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Comprehensive education group; The details of Comprehensive education are as follows: introduce the purpose, method and function of breathing training and the whole process of gastroscopy;; instruct patients to take deep breath training, inhaling with his/her nose and exhaling with his/her mouth,; provide patients with a disposable dental biting device and repeat exercising deep breathing again until he/she is fully mastered,; inform patients to cooperate with the instructions issued by endoscopist and endoscopy nurse during the whole process of gastroscopy,; 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,; inform patients that there would be some normal physiological reaction when gastroscopy, such as throat discomfort and nausea/vomiting.	Other: Comprehensive education group; The details of Comprehensive education are as follows: introduce the purpose, method and function of breathing training and the whole process of gastroscopy;; instruct patients to take deep breath training, inhaling with his/her nose and exhaling with his/her mouth,; provide patients with a disposable dental biting device and repeat exercising deep breathing again until he/she is fully mastered,; inform patients to cooperate with the instructions issued by endoscopist and endoscopy nurse during the whole process of gastroscopy,; 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,; inform patients that there would be some normal physiological reaction when gastroscopy, such as throat discomfort and nausea/vomiting.
No Intervention: standard education; The details of standard education are as follows: inform patients to cooperate with the instructions issued by endoscopist and endoscopy nurse during the whole process of gastroscopy,; inform patients that there would be some normal physiological reaction when gastroscopy, such as the throat discomfort and nausea/vomiting.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse reaction times in gastroscopy	research assistant records nausea/vomiting/retching times in the whole process of gastroscopy	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patients' tolerance scores	At the end of the procedure, the patients were asked about the tolerance in the process of gastroscopy by using a 100-mm visual analogue scale. Tolerance includes the extent of pain and nausea. The endpoints were assigned "no nausea or no pain " to the left and "worst possible nausea or worst pain imaginable " to the right.	1 day

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Endoscopists' assessment scores	At the end of the procedure, Endoscopists scored the level of difficulty in introduction of the gastroscope on a 100-mm visual analogue scale. The endpoints were assigned " easiest" to the left and " worst difficult " to the right. Endoscopists' satisfaction was assessed with 100-mm VAS for the performances of the endoscopes. The endpoints were assigned " worst dissatisfied" to the left and " Most satisfied " to the right.	1 day
Systolic/diastolic blood pressure (SBP/DBP)	Patients were monitored the Systolic/diastolic blood pressure (SBP/DBP) throughout using an electronic multifunctional patient monitor unit. The research assistant records Systolic/diastolic blood pressure (SBP/DBP) on 5 min prior to endoscopic intubation, during endoscopy and at time of entry into the stomach body	1 day
Pulse rate (PR)	Patients were monitored the pulse rate (PR) throughout using an electronic multifunctional patient monitor unit. The research assistant records pulse rate (PR) on 5 min prior to endoscopic intubation, during endoscopy and at time of entry into the stomach body.	1 day
Oxygen saturation by pulse oximetry (SpO2)	Patients were monitored the Oxygen saturation by pulse oximetry (SpO2) throughout using an electronic multifunctional patient monitor unit. The research assistant records oxygen saturation by pulse oximetry (SpO2) on 5 min prior to endoscopic intubation, during endoscopy and at time of entry into the stomach body.	1 day

Collaborators and Investigators

• Sponsor: Ningbo No. 1 Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 15, 2018
• Primary Completion (Actual): August 15, 2018
• Study Completion (Actual): September 15, 2018

Study Registration Dates

• First Submitted: August 8, 2018
• First Submitted That Met QC Criteria: August 17, 2018
• First Posted (Actual): August 20, 2018

Study Record Updates

• Last Update Posted (Actual): July 2, 2019
• Last Update Submitted That Met QC Criteria: June 30, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: 2018-R010

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No