Participants' Pain,Quality of Life and Hospital SatisfactionNCT06215482
The Effect of "Adjacent Bed Effect" Induced by Anxiety on the Perioperative Period of Patients With Chocolate Cyst of Ovary
An observational study of Participants' Pain,Quality of Life and Hospital Satisfaction, run by Second Affiliated Hospital of Wenzhou Medical University at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Participants' Pain,Quality of Life and Hospital Satisfaction
- How many people
- 42 participants
- Where
- 1 siteChina
- Study dates
- 22 Jul 2023to 23 Sep 2023
- How long will I take part?
- 2 Months
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Anxious or nonanxious state in participants with chocolate cysts
Who may be able to join
- Ovarian chocolate cyst diameter ≥4cm;
- Infertility;
- Dysmenorrhea medications were ineffective; Any one of the above, with or without clinical symptoms.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| "A-N" group (Anxious-Non-anxious group) | Upon admission, participants filled out a Anxiety Disorder Screening Scale, this group scored <10 points | |
| "N-N" group (Non-anxious-Non-anxious group) | Upon admission, participants filled out a Anxiety Disorder Screening Scale, this group scored ≥10 points |
What is being measured
The primary outcome is the main question the study is designed to answer.
participant demographic information
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
Measured: through study completion, an average of 2 month
Secondary outcomes (4)
Postoperative Scale scores
visual analogue scale were completed after operation; higher scores indicate more pain;Maximum 100 and minimum 0
Measured: through study completion, an average of 2 month
scale were completed after operation
Numerical Rating Scale for Pain scale were completed after operation;higher scores indicate more pain;Maximum 100 and minimum 0
Measured: through study completion, an average of 2 month
scale were completed after operation
Quality of Life Scale for patients with endometriosis were completed after operation; higher scores indicate worse quality of life;Maximum 100 and minimum 0
Measured: through study completion, an average of 2 month
scale were completed after operation
hospital satisfaction scale were completed after operation higher scores indicate more satisfied with the hospital; Maximum 100 and minimum 0
Measured: through study completion, an average of 2 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2024
- Study start22 Jul 2023
- Primary completion22 Sep 2023
- Study completion23 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Participants' Pain,Quality of Life and Hospital SatisfactionStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital of Wenzhou Medical UniversityThe 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
- Prospective
- Enrolment
- 42 participants (actual)
- Target duration
- 2 Months
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Qiong joan_zhang2002@sina.com, Study chair, Second Affiliated Hospital of Wenzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06215482
- Sponsor's protocol ID
- SAHoWMU-CR2024-07-201
- Status last verified
- Jan 2024
- First submitted
- 7 Jan 2024
- Last updated
- 22 Jan 2024
- 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 22 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of "Adjacent Bed Effect" Induced by Anxiety on the Perioperative Period of Patients With Chocolate Cyst of Ovary
- ClinicalTrials.gov ID
- NCT06215482
- Acronym / sponsor ID
- SAHoWMU-CR2024-07-201
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Second Affiliated Hospital of Wenzhou Medical UniversityUniversity, hospital or other
- Study start
- 22 Jul 2023 (actual)
- Primary completion
- 22 Sep 2023 (actual)
- Study completion
- 23 Sep 2023 (actual)
- First posted
- 22 Jan 2024 (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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| "A-N" group (Anxious-Non-anxious group) | – | –Upon admission, participants filled out a Anxiety Disorder Screening Scale, this group scored <10 points |
| "N-N" group (Non-anxious-Non-anxious group) | – | –Upon admission, participants filled out a Anxiety Disorder Screening Scale, this group scored ≥10 points |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Anxious or nonanxious state in participants with chocolate cysts
Key inclusion criteria (3 listed)
- Ovarian chocolate cyst diameter ≥4cm;
- Infertility;
- Dysmenorrhea medications were ineffective; Any one of the above, with or without clinical symptoms.
Key exclusion criteria (7 listed)
- 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;
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
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
4 secondary outcomes
Postoperative Scale scores
Time frame: through study completion, an average of 2 month
scale were completed after operation
Time frame: through study completion, an average of 2 month
scale were completed after operation
Time frame: through study completion, an average of 2 month
scale were completed after operation
Time frame: through study completion, an average of 2 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2024.
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.
Qiong joan_zhang2002@sina.com study chair
Second Affiliated Hospital of Wenzhou Medical University
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 Participants' Pain,Quality of Life and Hospital Satisfaction, run by Second Affiliated Hospital of Wenzhou Medical 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 7 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: finished, as of the sponsor's last update on 22 Jan 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
participant demographic information (time frame: through study completion, an average of 2 month). 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 22 Jan 2024.