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Completed

NCT Number: NCT03638752

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

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.

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Key information

Conditions

Comprehensive Education

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ningbo NO.1 hospital

Ningbo, Zhejiang, 315010, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients over the age of 18 years undergoing routine gastroscopy
  • Informed consent

Exclusion criteria

  • Serious coronary heart disease and myocardial injury with serious heart failure
  • Stenosis of the esophagus or cardia obstruction
  • Acute pharyngitis and tonsillitis
  • Acute upper gastrointestinal bleeding
  • Hemodynamically unstable
  • allergy to topical lidocaine
  • Patients did not cooperate or spirit was not normal
  • Pregnancy

Treatment and study plan

Comprehensive education group

Other

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.

Primary outcomes

  1. Adverse reaction times in gastroscopy

    Time frame: 1 day

    research assistant records nausea/vomiting/retching times in the whole process of gastroscopy

Secondary outcomes

  1. Patients' tolerance scores

    Time frame: 1 day

    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.

Other outcomes

  1. Endoscopists' assessment scores

    Time frame: 1 day

    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.

  2. Systolic/diastolic blood pressure (SBP/DBP)

    Time frame: 1 day

    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

  3. Pulse rate (PR)

    Time frame: 1 day

    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.

  4. Oxygen saturation by pulse oximetry (SpO2)

    Time frame: 1 day

    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.

Sponsors and collaborators

Lead sponsor

Ningbo No. 1 Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Aug 20, 2018
Registry last updated
Jul 2, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.