NCT07286877

Enhanced Ward Rounds and Communication for Pre-procedural Anxiety in GI Endoscopy Patients

Enhanced Ward-Round Frequency With Standardized Communication for Pre-procedural Anxiety in Hospitalized Patients Undergoing Therapeutic Gastrointestinal Endoscopy

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,000 (estimated)
• Sponsor: LanZhou University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study tests a new way to help reduce anxiety in hospitalized patients waiting for therapeutic gastrointestinal (GI) endoscopy procedures, like EMR or ESD. Anxiety before these procedures is common and can make preparation harder, increase medication needs, and affect recovery. We compare standard ward checks (twice a day) to enhanced checks (four times a day) with structured talks and simple relaxation exercises. The goal is to see if the enhanced approach lowers anxiety levels, measured by a standard scale called the Hamilton Anxiety Rating Scale (HAM-A), from baseline to 24 hours before the procedure. Who can join? Adults (18+) scheduled for inpatient GI endoscopy with at least 2 days hospital stay and mild anxiety. Exclusions include emergencies or severe mental health issues. The study is done in hospital wards, with groups assigned by ward periods to keep it real-world. Benefits may include less anxiety and better experience; risks are low as it's just more supportive talks. Participation is voluntary with informed consent. Results could improve hospital care routines.

Conditions

• Anxiety
• Depression Disorders
• Sleep Wake Disorders
• Gastrointestinal Diseases
• Preoperative Anxiety

Interventions

Type	Name	Description
BEHAVIORAL	Enhanced Ward-Round Frequency With Standardized Communication	In intervention wards/periods, the care team conducts four brief, structured ward-round contacts per day (morning, noon, afternoon, and a bedtime contact not later than 21:30), each lasting approximately 3-5 minutes. Each contact uses a standardized communication script that addresses patient concerns, provides concise procedure-related education, and includes a 2-3 minute relaxation/breathing exercise; for lower GI procedures, a bowel preparation checklist is reviewed and an information card is issued/verified. Delivery starts at enrollment and continues through 24-48 hours post-procedure or until discharge, whichever comes first. Staff receive standardized training; fidelity is monitored via daily checklists with an adherence target of ≥85%. Usual clinical care remains available at all times.
BEHAVIORAL	Usual Care Ward Rounds (2/day)	Routine ward rounds twice daily (morning and afternoon) according to standard hospital practice, without additional rounds, the standardized communication script, relaxation exercise, or the structured bowel preparation checklist beyond usual education. Applied from enrollment through 24-48 hours post-procedure or until discharge, whichever comes first. Any clinically necessary deviations are permitted and recorded as protocol deviations; all other aspects of care follow standard pathways.

Timeline

• Start date: 2026-01-15
• Primary completion: 2026-12-30
• Completion: 2027-02-20
• First posted: 2025-12-16
• Last updated: 2025-12-16

Locations

1 site across 1 country: China