Myoma of UterusNCT05596188
Anxiety Before Non-cardiac Surgery in Adults
An observational study of Myoma of Uterus and Colon Cancer, run by RenJi Hospital at 1 site in China.
Trial summary
Adult patients undergoing elective non-cardiac surgery were enrolled. Anxiety before the operation was evaluated by The State Anxiety Inventory (S-AI). Logistics regression would be used for identifying the independent factors of preoperative anxiety and prediction model would be established. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Myoma of Uterus, Colon Cancer, Gastric Carcinoma
- How many people
- 424 participants
- Where
- 1 siteChina
- Study dates
- 10 Nov 2022to 31 Mar 2024
- How long will I take part?
- 7 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients who met the eligibilty criteria for elective surgery under general anesthesia.
Who may be able to join
- patients undergoing elective with general anesthesia surgery (gynecologic oncology, general surgery, orthopedics and urinary);
- The estimated operation time is more than 2 hours. 3)18≤ age ≤ 80;
- 4)be able to communicate normally in daily life, without serious hearing and visual impairment; 5)ASA:I-II; 6)sign informed consent and volunteer to participate in this study.
Who cannot join
- Having a history of brain diseases, such as stroke, epilepsy, psychosis other history of neuropsychiatry.
- Patients with serious diseases of heart, liver, lung, kidney or other organs.
- Having a definite diagnosis of cognitive impairment, such as Alzheimer's disease;
- Those who use sedatives before evaluation in this study;
- Drug addicts;
- Alcoholics;
- pregnant women;
- participated in other clinical trials as a subject in the past 3 months.
Trial locations and contacts
1 site in 1 country.
Siyuan Sun contact
China1 site, 1 recruiting
- Recruiting
Renji Hospital
Shanghai, 200127
Min Chen, +862168383702, chenmin@renji.com
About this study
Official title: Status and Independent Risk Factors of Preoperative Anxiety in Adults Undergoing Non-cardiac Surgery: a Cross-sectional Study
Adult patients undergoing elective non-cardiac surgery were enrolled. Anxiety before the operation was evaluated by The State Anxiety Inventory (S-AI). Logistics regression would be used for identifying the independent factors of preoperative anxiety and prediction model would be established.
- Medical subject headings
- Colonic Neoplasms, Stomach Neoplasms, Prostatic Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Independent risk factors of preoperative anxiety and establishment of prediction model
To identify the independent factors related to preoperative anxiety, which would be analyzed by Logistic regression according to anxiety or not before surgery evaluated by the State anxiety inventory（20-80，lower is better) . Meanwhile, the prediction model of preoperative anxiety would be established based on independent factors.
Measured: From the 1 day before surgery to 7 days after surgery or discharge, whichever came first
Secondary outcomes (1)
Incidence of preoperative anxiety
The State anxiety inventory (20-80，lower is better) was used to investigate the incidence of Preoperative anxiety
Measured: The 1 day before surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2022
- Study start10 Nov 2022
- Primary completion17 Oct 2023 (estimated)
- Study completion31 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myoma of UterusStudies of the same condition, open and under way.
- More trials run by RenJi HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 424 participants (estimated)
- Target duration
- 7 Days
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05596188
- Sponsor's protocol ID
- SSY04070224
- Status last verified
- May 2023
- First submitted
- 23 Oct 2022
- Last updated
- 31 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Status and Independent Risk Factors of Preoperative Anxiety in Adults Undergoing Non-cardiac Surgery: a Cross-sectional Study
- ClinicalTrials.gov ID
- NCT05596188
- Acronym / sponsor ID
- SSY04070224
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 424 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- 10 Nov 2022 (actual)
- Primary completion
- 17 Oct 2023 (estimated)
- Study completion
- 31 Mar 2024 (estimated)
- First posted
- 27 Oct 2022 (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.
Adult patients undergoing elective non-cardiac surgery were enrolled. Anxiety before the operation was evaluated by The State Anxiety Inventory (S-AI). Logistics regression would be used for identifying the independent factors of preoperative anxiety and prediction model would be established.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 7 Days
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients who met the eligibilty criteria for elective surgery under general anesthesia.
Key inclusion criteria (3 listed)
- patients undergoing elective with general anesthesia surgery (gynecologic oncology, general surgery, orthopedics and urinary);
- The estimated operation time is more than 2 hours. 3)18≤ age ≤ 80;
- 4)be able to communicate normally in daily life, without serious hearing and visual impairment; 5)ASA:I-II; 6)sign informed consent and volunteer to participate in this study.
Key exclusion criteria (8 listed)
- Having a history of brain diseases, such as stroke, epilepsy, psychosis other history of neuropsychiatry.
- Patients with serious diseases of heart, liver, lung, kidney or other organs.
- Having a definite diagnosis of cognitive impairment, such as Alzheimer's disease;
- Those who use sedatives before evaluation in this study;
- Drug addicts;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Independent risk factors of preoperative anxiety and establishment of prediction model
Time frame: From the 1 day before surgery to 7 days after surgery or discharge, whichever came first
To identify the independent factors related to preoperative anxiety, which would be analyzed by Logistic regression according to anxiety or not before surgery evaluated by the State anxiety inventory（20-80，lower is better) . Meanwhile, the prediction model of preoperative anxiety would be established based on independent factors.
1 secondary outcome
Incidence of preoperative anxiety
Time frame: The 1 day before surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2023.
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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. This study is not recruiting at the moment.
Siyuan Sun contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myoma of Uterus and Colon Cancer, run by RenJi Hospital 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 8 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: status not confirmed, as of the sponsor's last update on 31 May 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Min Chen (+862168383702, chenmin@renji.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Independent risk factors of preoperative anxiety and establishment of prediction model (time frame: From the 1 day before surgery to 7 days after surgery or discharge, whichever came first). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 May 2023.