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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Gastrointestinal Diseases; Sleep Wake Disorders; Anxiety; Preoperative Anxiety; Depression Disorders
• Intervention / Treatment: Behavioral: Enhanced Ward-Round Frequency With Standardized Communication; Behavioral: Usual Care Ward Rounds (2/day)

• Study Type: Interventional
• Enrollment (Estimated): 1000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Qiangqiang Tian; Phone Number: 15009460497; Email: tianqq2023@lzu.edu.cn

Study Locations

• China
  • Gansu
    • Lanzhou, Gansu, China, 730000
      • The First Hospital of Lanzhou University
      • Contact: Qiangqiang Tian; Phone Number: 86+15009460497; Email: tianqq2023@lzu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Enhanced Ward Rounds (4/day) with Standardized Communication; 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.	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.; Other Names: Enhanced Ward Rounds; 4/day Ward Rounds; Standardized Communication Package
Active Comparator: Usual Care Ward Rounds (2/day); 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.	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.; Other Names: Usual Care; Standard Practice

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Hamilton Anxiety Rating Scale (HAM-A) Score	The Hamilton Anxiety Rating Scale (HAM-A) is a clinician-administered instrument assessing anxiety severity. Total score ranges from 0 to 56 points, with higher scores indicating worse anxiety. Score interpretation: 0-7 = no anxiety, 8-16 = mild anxiety, 17-24 = mild-to-moderate anxiety, 25-30 = moderate-to-severe anxiety, >30 = severe anxiety. Assessed by blinded research assistants using structured interview.	Baseline and 3 hours (±1 hours) before scheduled endoscopy procedure (assessed up to 14 days after enrollment)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) Overall Hospital Rating	HCAHPS Overall Hospital Rating measures patient satisfaction with hospital care on a scale of 0 to 10, where 0 = worst hospital possible and 10 = best hospital possible. Higher scores indicate better patient satisfaction.	At hospital discharge (assessed up to 21 days after enrollment)
HCAHPS Communication with Nurses Composite Score	HCAHPS Communication with Nurses composite includes 3 items rated on a 4-point frequency scale (Never/Sometimes/Usually/Always). Scores are converted to a 0-100 scale where higher scores indicate better nurse communication. Items assess whether nurses treated patient with courtesy/respect, listened carefully, and explained things understandably.	At hospital discharge (assessed up to 21 days after enrollment)
HCAHPS Communication with Doctors Composite Score	HCAHPS Communication with Doctors composite includes 3 items rated on a 4-point frequency scale (Never/Sometimes/Usually/Always). Scores are converted to a 0-100 scale where higher scores indicate better doctor communication. Items assess whether doctors treated patient with courtesy/respect, listened carefully, and explained things understandably.	At hospital discharge (assessed up to 21 days after enrollment)
Pittsburgh Sleep Quality Index (PSQI) Global Score	The Pittsburgh Sleep Quality Index (PSQI) assesses sleep quality over the previous night. Global score ranges from 0 to 21, with higher scores indicating worse sleep quality. A global score >5 indicates poor sleep quality.	Baseline, Day 2 post-enrollment, and 24 hours before procedure (assessed up to 14 days after enrollment)
Procedural Pain/Discomfort Visual Analog Scale (VAS)	Visual Analog Scale (VAS) for procedural pain and discomfort ranges from 0 to 10, where 0 = no pain/discomfort and 10 = worst imaginable pain/discomfort. Higher scores indicate worse pain/discomfort. Assessed immediately post-procedure.	Within 30 minutes after endoscopy procedure completion
Total Sedation Medication Dose (Midazolam Equivalents)	Total sedation medication dose administered during endoscopy, calculated as midazolam equivalents in milligrams (mg). Conversion formula: midazolam (mg) + propofol (mg)/20 + fentanyl (mcg)/100. Lower doses indicate less sedation requirement.	During endoscopy procedure (assessed up to 14 days after enrollment)
Endoscopy Procedure Duration	Total procedure time in minutes, measured from endoscope insertion to withdrawal. Shorter duration may indicate better patient tolerance and cooperation.	Measured intraoperatively from endoscope insertion to withdrawal; endoscopy procedure occurs within 14 days of enrollment
Incidence of Peri-procedural Adverse Events	Number of participants experiencing adverse events during or within 24 hours post-procedure, graded by American Society for Gastrointestinal Endoscopy (ASGE) severity classification: mild (requires observation only), moderate (requires medical intervention), severe (requires hospitalization or ICU admission), or fatal. Events include cardiopulmonary complications (hypoxia, hypotension, arrhythmia), perforation, bleeding, aspiration, or other complications.	From procedure start through 24 hours post-procedure (assessed up to 15 days after enrollment)
Hospital Length of Stay	Total hospital length of stay measured in days from admission to discharge. Shorter length of stay indicates more efficient care and potentially fewer complications.	From hospital admission to discharge (assessed up to 28 days)
30-Day Unplanned Hospital Readmission Rate	Proportion of participants with unplanned hospital readmission related to the index endoscopy procedure or its complications within 30 days of hospital discharge. Lower rates indicate better outcomes and care quality.	From hospital discharge through 30 days post-discharge

Collaborators and Investigators

• Sponsor: LanZhou University

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Estimated): January 15, 2026
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): February 20, 2027

Study Registration Dates

• First Submitted: November 14, 2025
• First Submitted That Met QC Criteria: December 13, 2025
• First Posted (Actual): December 16, 2025

Study Record Updates

• Last Update Posted (Actual): December 16, 2025
• Last Update Submitted That Met QC Criteria: December 13, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Mental Disorders; Digestive System Diseases; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Gastrointestinal Diseases; Anxiety Disorders; Sleep Wake Disorders
• Other Study ID Numbers: LDYYczf2025110501

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No