- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03638752
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
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
Zhejiang
-
Ningbo, Zhejiang, Kina, 315010
- Ningbo NO.1 hospital
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Diagnostisk
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Comprehensive education group
The details of Comprehensive education are as follows:
|
The details of Comprehensive education are as follows:
|
|
Ingen indgriben: standard education
The details of standard education are as follows:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Adverse reaction times in gastroscopy
Tidsramme: 1 day
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research assistant records nausea/vomiting/retching times in the whole process of gastroscopy
|
1 day
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Patients' tolerance scores
Tidsramme: 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.
|
1 day
|
Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Endoscopists' assessment scores
Tidsramme: 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. |
1 day
|
|
Systolic/diastolic blood pressure (SBP/DBP)
Tidsramme: 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
|
1 day
|
|
Pulse rate (PR)
Tidsramme: 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.
|
1 day
|
|
Oxygen saturation by pulse oximetry (SpO2)
Tidsramme: 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.
|
1 day
|
Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- 2018-R010
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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