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Prospective observational study on Patient's distress in Esophagogastroduodenoscopy

Prospective observational study on Patient's distress in Esophagogastroduodenoscopy - Prospective observational study on Patient's distress in Esophagogastroduodenoscopy

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000043688
Enrollment
140
Registered
2021-05-26
Start date
2021-08-09
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

esophagogastroduodenoscopy

Interventions

None listed

Sponsors

Okayama University Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: The esophagogastroduodenoscopy cases that seven endoscopists will be in charge of between May 2021 and March 2022 that meet the following selection criteria (1) 10 cases of normal diameter endoscopy and 10 cases of small diameter endoscopy (whether normal diameter or small diameter will be determined clinically) (2) The purpose of the examination is asymptomatic screening or post-treatment surveillance. (3) Patients who can provide written consent for participation in the study of their own free will (4) Patients whose age at the time of obtaining consent is between 20 and 80 years old.

Exclusion criteria

Exclusion criteria: (1) Women who are pregnant or may become pregnant (2) Patients who wish to be sedated during endoscopy. (3) Patients with PS of more than 3 (4) Patients with lesions that require treatment or detailed examination. However, follow-up observation of the size and shape of the lesion is acceptable. (5) Patients for whom the examination time is expected to exceed 10 minutes. (6) Endoscopic ultrasound examination. (7) After treatment for pharyngeal, laryngeal, or esophageal cancer (8) The patients who were remnant stomach or gastric tube. (9) Other cases deemed unsuitable by the physician in charge.

Design outcomes

Primary

MeasureTime frame
The timing and degree of the distress that patients feel during esophagogastroduodenoscopy without sedation

Secondary

MeasureTime frame
-Factors associated with distress during esophagogastroduodenoscopy -The relationship between blood pressure, pulse rate, and SpO2 and the timing and indegree of the distress. -Differences in perceptions of distress between endoscopist and patients based on post-endoscopy questionnaires. -Comparison of strongest distress level and distress frequency with the examining physician. -Strongest pain level and pain frequency compared with endoscope type (small diameter and normal diameter). -Comparison of exam distress with desire for next exam or sedation.

Countries

Japan

Contacts

Public ContactHiromitsu Kanzaki

Okayama University Hospital Gastroenterology

kanzaki@qc4.so-net.ne.jp086-235-7219

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026