Enhanced Ward-Round Frequency With Standardized Communication for Pre-procedural Anxiety in Hospitalized Patients Undergoing Therapeutic Gastrointestinal Endoscopy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Change in Hamilton Anxiety Rating Scale (HAM-A) Score
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years.
- •Inpatients scheduled for therapeutic gastrointestinal endoscopy (e.g., ESD/EMR, therapeutic colonoscopy).
- •Able to provide informed consent and complete required assessments.
排除标准
- •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.
结局指标
主要结局
Change in Hamilton Anxiety Rating Scale (HAM-A) Score
时间窗: 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.
次要结局
- Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) Overall Hospital Rating(At hospital discharge (assessed up to 21 days after enrollment))
- Procedural Pain/Discomfort Visual Analog Scale (VAS)(Within 30 minutes after endoscopy procedure completion)
- Total Sedation Medication Dose (Midazolam Equivalents)(During endoscopy procedure (assessed up to 14 days after enrollment))
- HCAHPS Communication with Nurses Composite Score(At hospital discharge (assessed up to 21 days after enrollment))
- Hospital Length of Stay(From hospital admission to discharge (assessed up to 28 days))
- 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))
- Incidence of Peri-procedural Adverse Events(From procedure start through 24 hours post-procedure (assessed up to 15 days after enrollment))
- Endoscopy Procedure Duration(Measured intraoperatively from endoscope insertion to withdrawal; endoscopy procedure occurs within 14 days of enrollment)
- 30-Day Unplanned Hospital Readmission Rate(From hospital discharge through 30 days post-discharge)
研究者
Zhaofeng Chen
Clinical Professor
LanZhou University