Comprehensive EducationNCT03638752
The Impact of Comprehensive Education Before Gastroscopy on Improving the Tolerance of Patients
A study testing Comprehensive education group in people with Comprehensive Education, run by Ningbo No. 1 Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Comprehensive Education
- What is being tested?
- Comprehensive education group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- 1 siteChina
- Study dates
- 15 Aug 2018to 15 Sep 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients over the age of 18 years undergoing routine gastroscopy
- Informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Comprehensive Education
- Being tested
- Comprehensive education group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comprehensive education groupOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Comprehensive education group | Experimental | 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. Receives: Other: Comprehensive education group |
| standard education | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse reaction times in gastroscopy
research assistant records nausea/vomiting/retching times in the whole process of gastroscopy
Measured: 1 day
Secondary outcomes (1)
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.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2018
- Study start15 Aug 2018
- Primary completion15 Aug 2018
- Study completion15 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Comprehensive EducationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 260 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ningbo No. 1 Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lei Xu, PHD, Principal investigator, Department of Gastroenterology, Ningbo No. 1 Hospital, Ningbo, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03638752
- Sponsor's protocol ID
- 2018-R010
- Status last verified
- Jun 2019
- First submitted
- 8 Aug 2018
- Last updated
- 2 Jul 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Comprehensive Education Before Gastroscopy on Improving the Tolerance of Patients: A Prospective Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT03638752
- Acronym / sponsor ID
- 2018-R010
- Conditions
- Comprehensive Education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 260 participants (actual)
- Lead sponsor
- Ningbo No. 1 HospitalUniversity, hospital or other
- Study start
- 15 Aug 2018 (actual)
- Primary completion
- 15 Aug 2018 (actual)
- Study completion
- 15 Sep 2018 (actual)
- First posted
- 20 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Comprehensive education group | Experimental | Other: Comprehensive education groupThe 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 | No intervention | –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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients over the age of 18 years undergoing routine gastroscopy
- Informed consent
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Comprehensive education groupThe 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. | Other | Comprehensive education group |
Primary outcome
Adverse reaction times in gastroscopy
Time frame: 1 day
research assistant records nausea/vomiting/retching times in the whole process of gastroscopy
1 secondary outcome
Patients' tolerance scores
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lei Xu, PHD principal investigator
Department of Gastroenterology, Ningbo No. 1 Hospital, Ningbo, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Comprehensive education group in people with Comprehensive Education, run by Ningbo No. 1 Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse reaction times in gastroscopy (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2019.