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

Lanzhou University

Status: Not yet enrolling

Conditions: Gastrointestinal Diseases; Depression Disorders; Anxiety; Preoperative Anxiety; Sleep Wake Disorders

Treatments: Behavioral: Usual Care Ward Rounds (2/day); Behavioral: Enhanced Ward-Round Frequency With Standardized Communication

Study type: Interventional

Funder types: Other

Identifiers

NCT07286877

LDYYczf2025110501

Details and patient eligibility

About

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.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age ≥18 years.
2. Inpatients scheduled for therapeutic gastrointestinal endoscopy (e.g., ESD/EMR, therapeutic colonoscopy).
3. Able to provide informed consent and complete required assessments.

Exclusion criteria

Emergency/immediate endoscopy required.

1. Severe cognitive impairment or psychotic disorder affecting assessments. Isolation/single room preventing protocol implementation.
2. Unable to complete the primary pre-procedure assessment within the 2-4 hour window.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,000 participants in 2 patient groups

Enhanced Ward Rounds (4/day) with Standardized Communication

Experimental group

Description:

In intervention wards/periods, the care team conducts four brief, structured ward-round contacts per day (morning 07:00-09:00, midday 11:00-13:00, afternoon 15:00-17:00, and bedtime 19:00-21:30), each lasting approximately 3-5 minutes. Each contact uses a standardized communication script addressing patient concerns, provides concise procedure-related education, and includes a 2-3 minute relaxation/breathing exercise. For patients undergoing lower GI procedures, a bowel preparation checklist is reviewed and an information card is issued/verified at each contact. Delivery starts at enrollment and continues through 24-48 hours post-procedure or until discharge, whichever comes first. Staff receive standardized training with competency assessment; fidelity is monitored via daily checklists with an adherence target of ≥85%. All usual clinical care remains available at all times.

Treatment:

Behavioral: Enhanced Ward-Round Frequency With Standardized Communication

Usual Care Ward Rounds (2/day)

Active Comparator group

Description:

Routine ward rounds twice daily (morning 07:00-09:00 and afternoon 15:00-17:00) according to standard hospital practice, without additional structured rounds, standardized communication scripts, scheduled relaxation exercises, or structured bowel preparation checklists beyond usual patient education. Applied from enrollment through 24-48 hours post-procedure or until discharge, whichever comes first. Clinically necessary additional contacts are permitted and recorded as protocol deviations. All other aspects of care follow standard institutional pathways.

Treatment:

Behavioral: Usual Care Ward Rounds (2/day)