Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07286877

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

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Anxiety Anxiety Disorders Depression Disorders Digestive System Diseases Gastrointestinal Diseases Mental Disorders Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Preoperative Anxiety Signs and Symptoms Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The First Hospital of Lanzhou University

Lanzhou, Gansu, 730000, China

Location contact

Qiangqiang Tian

CONTACT

[email protected]

86+15009460497

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: Enhanced Ward Rounds; 4/day Ward Rounds; Standardized Communication Package

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.

Other names: Usual Care; Standard Practice

Primary outcomes

  1. 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)

    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.

Secondary outcomes

  1. 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 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.

  2. HCAHPS Communication with Nurses Composite Score

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

    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.

  3. HCAHPS Communication with Doctors Composite Score

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

    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.

  4. 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)

    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.

  5. Procedural Pain/Discomfort Visual Analog Scale (VAS)

    Time frame: Within 30 minutes after endoscopy procedure completion

    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.

  6. Total Sedation Medication Dose (Midazolam Equivalents)

    Time frame: During endoscopy procedure (assessed up to 14 days after enrollment)

    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.

  7. Endoscopy Procedure Duration

    Time frame: Measured intraoperatively from endoscope insertion to withdrawal; endoscopy procedure occurs within 14 days of enrollment

    Total procedure time in minutes, measured from endoscope insertion to withdrawal. Shorter duration may indicate better patient tolerance and cooperation.

  8. Incidence of Peri-procedural Adverse Events

    Time frame: From procedure start through 24 hours post-procedure (assessed up to 15 days after enrollment)

    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.

  9. Hospital Length of Stay

    Time frame: From hospital admission to discharge (assessed up to 28 days)

    Total hospital length of stay measured in days from admission to discharge. Shorter length of stay indicates more efficient care and potentially fewer complications.

  10. 30-Day Unplanned Hospital Readmission Rate

    Time frame: From hospital discharge through 30 days post-discharge

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Qiangqiang Tian

CONTACT

[email protected]

15009460497

Sponsors and collaborators

Lead sponsor

LanZhou University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Dec 16, 2025
Registry last updated
Dec 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.