AnxietyNCT07286877
Enhanced Ward Rounds and Communication for Pre-procedural Anxiety in GI Endoscopy Patients
A study testing Enhanced Ward-Round Frequency With Standardized Communication in people with Anxiety and Depression Disorders, run by LanZhou University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anxiety, Depression Disorders, Sleep Wake Disorders
- What is being tested?
- Enhanced Ward-Round Frequency With Standardized Communication
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 15 Jan 2026to 20 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years.
- Inpatients scheduled for therapeutic gastrointestinal endoscopy (e.g., ESD/EMR, therapeutic colonoscopy).
- Able to provide informed consent and complete required assessments.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The First Hospital of Lanzhou University
Lanzhou, Gansu, 730000
Qiangqiang Tian, 86+15009460497, tianqq2023@lzu.edu.cn
About this study
Official title: 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.
Read more
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
- Being tested
- Enhanced Ward-Round Frequency With Standardized Communication, Usual Care Ward Rounds (2/day)
- Medical subject headings
- Anxiety Disorders, Sleep Wake Disorders, Gastrointestinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced Ward-Round Frequency With Standardized CommunicationBehavioural
Also called Enhanced Ward Rounds; 4/day Ward Rounds; Standardized Communication Package
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)Behavioural
Also called Usual Care; Standard Practice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Usual Care Ward Rounds (2/day) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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: 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.
Measured: 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.
Measured: 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.
Measured: From hospital discharge through 30 days post-discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2025
- Study start15 Jan 2026 (estimated)
- Primary completion30 Dec 2026 (estimated)
- Study completion20 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- LanZhou University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhaofeng Chen, LanZhou University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07286877
- Sponsor's protocol ID
- LDYYczf2025110501
- Status last verified
- Dec 2025
- First submitted
- 14 Nov 2025
- Last updated
- 16 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 13638508
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhanced Ward-Round Frequency With Standardized Communication for Pre-procedural Anxiety in Hospitalized Patients Undergoing Therapeutic Gastrointestinal Endoscopy
- ClinicalTrials.gov ID
- NCT07286877
- Acronym / sponsor ID
- LDYYczf2025110501
- Conditions
- Anxiety, Depression Disorders, Sleep Wake Disorders, Gastrointestinal Diseases, Preoperative Anxiety
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- LanZhou UniversityUniversity, hospital or other
- Study start
- 15 Jan 2026 (estimated)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 20 Feb 2027 (estimated)
- First posted
- 16 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Enhanced Ward Rounds (4/day) with Standardized Communication | Experimental | Behavioral: Enhanced Ward-Round Frequency With Standardized CommunicationIn 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. |
| Usual Care Ward Rounds (2/day) | Active comparator | Behavioral: 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥18 years.
- Inpatients scheduled for therapeutic gastrointestinal endoscopy (e.g., ESD/EMR, therapeutic colonoscopy).
- Able to provide informed consent and complete required assessments.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Enhanced Ward-Round Frequency With Standardized CommunicationAlso: Enhanced Ward Rounds; 4/day Ward Rounds; Standardized Communication PackageIn 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. | Behavioural | Enhanced Ward Rounds (4/day) with Standardized Communication |
| Usual Care Ward Rounds (2/day)Also: Usual Care; Standard PracticeRoutine 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. | Behavioural | Usual Care Ward Rounds (2/day) |
Primary outcome
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.
10 secondary outcomes
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 Communication with Nurses Composite Score
Time frame: At hospital discharge (assessed up to 21 days after enrollment)
HCAHPS Communication with Doctors Composite Score
Time frame: At hospital discharge (assessed up to 21 days after enrollment)
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)
Procedural Pain/Discomfort Visual Analog Scale (VAS)
Time frame: Within 30 minutes after endoscopy procedure completion
Total Sedation Medication Dose (Midazolam Equivalents)
Time frame: During endoscopy procedure (assessed up to 14 days after enrollment)
Endoscopy Procedure Duration
Time frame: Measured intraoperatively from endoscope insertion to withdrawal; endoscopy procedure occurs within 14 days of enrollment
Incidence of Peri-procedural Adverse Events
Time frame: From procedure start through 24 hours post-procedure (assessed up to 15 days after enrollment)
Hospital Length of Stay
Time frame: From hospital admission to discharge (assessed up to 28 days)
30-Day Unplanned Hospital Readmission Rate
Time frame: From hospital discharge through 30 days post-discharge
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2025.
- Background: PubMed 13638508HAMILTON 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enhanced Ward-Round Frequency With Standardized Communication in people with Anxiety and Depression Disorders, run by LanZhou University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Qiangqiang Tian (15009460497, tianqq2023@lzu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07286877, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2025.