Anti-Glaucoma MedicationsNCT06478095
Preoperative Visual Aids on Glaucoma Surgical Patients
A study testing Visual aids in people with Anti-Glaucoma Medications, run by Joint Shantou International Eye Center of Shantou University and the Chinese University of Hong Kong at 1 site in China.
Trial summary
This study aims to evaluate the impact of preoperative visual aids on anxiety and pain management in patients with low educational backgrounds undergoing glaucoma filtration surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anti-Glaucoma Medications
- What is being tested?
- Visual aids
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 133 participants
- Where
- 1 siteChina
- Study dates
- 8 Mar 2023to 28 Mar 2024
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult inpatients with age ≥18 years
- Illiterate or with ≤ 9 years of compulsory education
- Indications for filtering surgery
Who cannot join
- Mental illness
- Cognitive impairment
Trial locations and contacts
1 site in 1 country.
China1 site
Joint Shantou International Eye Center of Shantou University and the Chinese University of Hong Kong
Shantou, Guangdong, 515041
About this study
Official title: Preoperative Visual Aids on Patients With Low Educational Backgrounds Undergoing Glaucoma Filtration Surgery
This study aims to evaluate the impact of preoperative visual aids on anxiety and pain management in patients with low educational backgrounds undergoing glaucoma filtration surgery.
Read the detailed description
A randomized, single-blinded, single-centre clinical trial was conducted at a tertiary eye hospital in Shantou, China. Patients scheduled for glaucoma filtration surgery were randomly assigned to either a conventional oral education group or a visual aids group. Anxiety levels, pain scores, blood pressure, and pulse rates were measured at multiple time points.
- Conditions
- Anti-Glaucoma Medications
- Being tested
- Visual aids
- Keywords
- Preoperative visit;glaucoma;filtering surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Visual aidsBehavioural
Diagrams, models, and videos
| Study group | Role | What they receive |
|---|---|---|
| The conventional oral education group | No intervention | Patients were only orally educated about glaucoma, preoperative preparation, surgical procedures, anaesthesia methods, and precautions during the preoperative visit. |
| The Visual aids plus conventional oral education group | Experimental | Patients were orally educated about glaucoma, preoperative preparation, surgical procedures, anaesthesia methods, and precautions with pictures and videos during the preoperative visit. Receives: Behavioral: Visual aids |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety levels, pain scores, blood pressure, and pulse rates
measured at multiple time points
Measured: 1 day prior to surgery; 30 minutes prior to surgery; 5 minutes after the onset of surgery; the conclusion of the surgical procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2024
- Study start8 Mar 2023
- Primary completion21 Feb 2024
- Study completion28 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anti-Glaucoma MedicationsStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 133 participants (actual)
Sponsor and investigators
- Lead sponsor
- Joint Shantou International Eye Center of Shantou University and the Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Shantou University Medical College
- Responsible party
- Principal investigator, Laiwen Lv, Joint Shantou International Eye Center of Shantou University and the Chinese University of Hong Kong
- Investigators
- Chukai Huang, PhD, Study director, Joint Shantou International Eye Center of Shantou University and the Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06478095
- Sponsor's protocol ID
- EC 20220505(4)-P30
- Status last verified
- Jun 2024
- First submitted
- 24 Jun 2024
- Last updated
- 28 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The individual participant data can be requested and accessed by contacting the study management teams of the studies on reasonable request. Such requests are adjudicated on a case-by-case basis. The study protocol and statistical analysis plan will be available and be accessed once the paper is accepted.
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Visual Aids on Patients With Low Educational Backgrounds Undergoing Glaucoma Filtration Surgery
- ClinicalTrials.gov ID
- NCT06478095
- Acronym / sponsor ID
- EC 20220505(4)-P30
- Conditions
- Anti-Glaucoma Medications
- Keywords
- Preoperative visit;glaucoma;filtering surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 133 participants (actual)
- Lead sponsor
- Joint Shantou International Eye Center of Shantou University and the Chinese University of Hong KongUniversity, hospital or other
- Collaborators
- Shantou University Medical College
- Study start
- 8 Mar 2023 (actual)
- Primary completion
- 21 Feb 2024 (actual)
- Study completion
- 28 Mar 2024 (actual)
- First posted
- 27 Jun 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.
This study aims to evaluate the impact of preoperative visual aids on anxiety and pain management in patients with low educational backgrounds undergoing glaucoma filtration surgery.
Detailed description
A randomized, single-blinded, single-centre clinical trial was conducted at a tertiary eye hospital in Shantou, China. Patients scheduled for glaucoma filtration surgery were randomly assigned to either a conventional oral education group or a visual aids group. Anxiety levels, pain scores, blood pressure, and pulse rates were measured at multiple time points.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The conventional oral education group | No intervention | –Patients were only orally educated about glaucoma, preoperative preparation, surgical procedures, anaesthesia methods, and precautions during the preoperative visit. |
| The Visual aids plus conventional oral education group | Experimental | Behavioral: Visual aidsPatients were orally educated about glaucoma, preoperative preparation, surgical procedures, anaesthesia methods, and precautions with pictures and videos during the preoperative visit. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult inpatients with age ≥18 years
- Illiterate or with ≤ 9 years of compulsory education
- Indications for filtering surgery
Key exclusion criteria (2 listed)
- Mental illness
- Cognitive impairment
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 |
|---|---|---|
| Visual aidsDiagrams, models, and videos | Behavioural | The Visual aids plus conventional oral education group |
Primary outcome
Anxiety levels, pain scores, blood pressure, and pulse rates
Time frame: 1 day prior to surgery; 30 minutes prior to surgery; 5 minutes after the onset of surgery; the conclusion of the surgical procedure
measured at multiple time points
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 28 Jun 2024.
- Individual participant dataSharing planned: No. The individual participant data can be requested and accessed by contacting the study management teams of the studies on reasonable request. Such requests are adjudicated on a case-by-case basis. The study protocol and statistical analysis plan will be available and be accessed once the paper is accepted.
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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.
Chukai Huang, PhD study director
Joint Shantou International Eye Center of Shantou University and the Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Visual aids in people with Anti-Glaucoma Medications, run by Joint Shantou International Eye Center of Shantou University and the Chinese University of Hong Kong 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 2 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 28 Jun 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?
Anxiety levels, pain scores, blood pressure, and pulse rates (time frame: 1 day prior to surgery; 30 minutes prior to surgery; 5 minutes after the onset of surgery; the conclusion of the surgical procedure). 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 28 Jun 2024.