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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03638752
Enrollment
260
Registered
2018-08-20
Start date
2018-08-15
Completion date
2018-09-15
Last updated
2019-07-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Comprehensive Education

Brief summary

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.

Interventions

OTHERComprehensive 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.

Sponsors

Ningbo No. 1 Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Caregiver, Investigator)

Masking description

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Adverse reaction times in gastroscopy1 dayresearch assistant records nausea/vomiting/retching times in the whole process of gastroscopy

Secondary

MeasureTime frameDescription
Patients' tolerance scores1 dayAt 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.

Other

MeasureTime frameDescription
Endoscopists' assessment scores1 dayAt 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.
Systolic/diastolic blood pressure (SBP/DBP)1 dayPatients 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
Pulse rate (PR)1 dayPatients 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.
Oxygen saturation by pulse oximetry (SpO2)1 dayPatients 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.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026