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

NCT ID: NCT07286877

Last Updated: 2025-12-16

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 1000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-15
• Study Completion Date: 2027-02-20

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Enhanced Ward-Round Frequency With Standardized Communication

Intervention Type: 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.

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.

Group Type: ACTIVE_COMPARATOR

Usual Care Ward Rounds (2/day)

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Other Intervention Names

Enhanced Ward Rounds; 4/day Ward Rounds; Standardized Communication Package; Usual Care; Standard Practice

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

LanZhou University

OTHER

Sponsor Role: lead

Responsible Party

Zhaofeng Chen

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

The First Hospital of Lanzhou University

Lanzhou, Gansu, China

Countries

China

Central Contacts

Qiangqiang Tian

Role: CONTACT

tianqq2023@lzu.edu.cn

15009460497

Facility Contacts

Qiangqiang Tian

Role: primary

tianqq2023@lzu.edu.cn

86+15009460497

References

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.

Reference Type: BACKGROUND

PMID: 13638508 (View on PubMed)

Other Identifiers

LDYYczf2025110501

Identifier Type: -

Identifier Source: org_study_id