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

NCT07286877 | Not Yet Recruiting

• 1 other identifier: LDYYczf2025110501
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) Overall Hospital Rating

  At hospital discharge (assessed up to 21 days after enrollment)

• HCAHPS Communication with Nurses Composite Score

  At hospital discharge (assessed up to 21 days after enrollment)

• HCAHPS Communication with Doctors Composite Score

  At hospital discharge (assessed up to 21 days after enrollment)

• Pittsburgh Sleep Quality Index (PSQI) Global Score

  Baseline, Day 2 post-enrollment, and 24 hours before procedure (assessed up to 14 days after enrollment)

• Procedural Pain/Discomfort Visual Analog Scale (VAS)

  Within 30 minutes after endoscopy procedure completion

Study Arms (2)

Enhanced Ward Rounds (4/day) with Standardized Communication

EXPERIMENTAL

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

Usual Care Ward Rounds (2/day)

ACTIVE COMPARATOR

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)

Interventions

Enhanced Ward-Round Frequency With Standardized Communication BEHAVIORAL

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.

Also known as: Enhanced Ward Rounds; 4/day Ward Rounds; Standardized Communication Package

Enhanced Ward Rounds (4/day) with Standardized Communication

Usual Care Ward Rounds (2/day) BEHAVIORAL

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.

Also known as: Usual Care; Standard Practice

Usual Care Ward Rounds (2/day)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• LanZhou University: lead

Study Sites (1)

The First Hospital of Lanzhou University

Lanzhou, Gansu, 730000, China

Location

Related Publications (1)

• 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 BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders; Sleep Wake Disorders; Gastrointestinal Diseases

Condition Hierarchy (Ancestors)

Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Digestive System Diseases

Central Study Contacts

Qiangqiang Tian

CONTACT

15009460497; tianqq2023@lzu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: December 16, 2025
• Study Start: January 15, 2026
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): February 20, 2027
• Last Updated: December 16, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)