- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06215482
The Effect of "Adjacent Bed Effect" Induced by Anxiety on the Perioperative Period of Patients With Chocolate Cyst of Ovary
January 18, 2024 updated by: Second Affiliated Hospital of Wenzhou Medical University
The "adjacent bed effect" caused by anxiety leads to poor recovery of participants after ovarian chocolate cyst surgery, including pain and quality of life, and affects participant satisfaction with the hospital.
Study Overview
Status
Completed
Study Type
Observational
Enrollment (Actual)
42
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Wenzhou, China, Zhejiang
- Qiong Zhang
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
Anxious or nonanxious state in participants with chocolate cysts
Description
Inclusion Criteria:
- Ovarian chocolate cyst diameter ≥4cm;
- Infertility;
- Dysmenorrhea medications were ineffective; Any one of the above, with or without clinical symptoms.
Exclusion Criteria:
- Age <18 years old;
- Previous history of other surgeries;
- Previous history of nervous system diseases, such as Parkinson's disease, dementia, etc.
- Previous history of blood system diseases, such as leukemia;
- Unable to tolerate surgery due to serious complications, such as serious cardiovascular and cerebrovascular diseases;
- Inability to complete the questionnaire due to language or learning disabilities;
- Those who don't want to participate.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
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"A-N" group (Anxious-Non-anxious group)
Upon admission, participants filled out a Anxiety Disorder Screening Scale, this group scored <10 points
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"N-N" group (Non-anxious-Non-anxious group)
Upon admission, participants filled out a Anxiety Disorder Screening Scale, this group scored ≥10 points
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
participant demographic information
Time Frame: through study completion, an average of 2 month
|
A self-rating anxiety scale was filled out and part of the participant's clinical information was collected,higher scores indicate more anxiety; Maximum 100 and minimum 0
|
through study completion, an average of 2 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postoperative Scale scores
Time Frame: through study completion, an average of 2 month
|
visual analogue scale were completed after operation; higher scores indicate more pain;Maximum 100 and minimum 0
|
through study completion, an average of 2 month
|
|
scale were completed after operation
Time Frame: through study completion, an average of 2 month
|
Numerical Rating Scale for Pain scale were completed after operation;higher scores indicate more pain;Maximum 100 and minimum 0
|
through study completion, an average of 2 month
|
|
scale were completed after operation
Time Frame: through study completion, an average of 2 month
|
Quality of Life Scale for patients with endometriosis were completed after operation; higher scores indicate worse quality of life;Maximum 100 and minimum 0
|
through study completion, an average of 2 month
|
|
scale were completed after operation
Time Frame: through study completion, an average of 2 month
|
hospital satisfaction scale were completed after operation higher scores indicate more satisfied with the hospital; Maximum 100 and minimum 0
|
through study completion, an average of 2 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: Qiong joan_zhang2002@sina.com, Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 22, 2023
Primary Completion (Actual)
September 22, 2023
Study Completion (Actual)
September 23, 2023
Study Registration Dates
First Submitted
January 7, 2024
First Submitted That Met QC Criteria
January 18, 2024
First Posted (Actual)
January 22, 2024
Study Record Updates
Last Update Posted (Actual)
January 22, 2024
Last Update Submitted That Met QC Criteria
January 18, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Other Study ID Numbers
- SAHoWMU-CR2024-07-201
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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