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

Official title

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

Overview

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.

Interventions

• 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
• 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.

Primary outcome measures

• Change in Hamilton Anxiety Rating Scale (HAM-A) Score [Time frame: Baseline and 3 hours (±1 hours) before scheduled endoscopy procedure (assessed up to 14 days after enrollment)]

Secondary outcome measures (10)

• Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) Overall Hospital Rating [Time frame: At hospital discharge (assessed up to 21 days after enrollment)]
• HCAHPS Communication with Nurses Composite Score [Time frame: At hospital discharge (assessed up to 21 days after enrollment)]
• HCAHPS Communication with Doctors Composite Score [Time frame: At hospital discharge (assessed up to 21 days after enrollment)]
• Pittsburgh Sleep Quality Index (PSQI) Global Score [Time frame: Baseline, Day 2 post-enrollment, and 24 hours before procedure (assessed up to 14 days after enrollment)]
• Procedural Pain/Discomfort Visual Analog Scale (VAS) [Time frame: Within 30 minutes after endoscopy procedure completion]
• Total Sedation Medication Dose (Midazolam Equivalents) [Time frame: During endoscopy procedure (assessed up to 14 days after enrollment)]
• Endoscopy Procedure Duration [Time frame: Measured intraoperatively from endoscope insertion to withdrawal; endoscopy procedure occurs within 14 days of enrollment]
• Incidence of Peri-procedural Adverse Events [Time frame: From procedure start through 24 hours post-procedure (assessed up to 15 days after enrollment)]
• Hospital Length of Stay [Time frame: From hospital admission to discharge (assessed up to 28 days)]
• 30-Day Unplanned Hospital Readmission Rate [Time frame: From hospital discharge through 30 days post-discharge]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

Emergency/immediate endoscopy required.

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Health services research

Study locations

China · 1 center

• The First Hospital of Lanzhou University — Lanzhou

Publications

• HAMILTON M. The assessment of anxiety states by rating. Br J Med Psychol. 1959;32(1):50-5. doi: 10.1111/j.2044-8341.1959.tb00467.x. No abstract available. PMID 13638508

Identifiers

NCT: NCT07286877 · LDYYczf2025110501

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗