Anxiety and Surgery Satisfaction for Cataract Patient With Different State Anxiety (NCT06826417) | Clinical Trial Compass
RecruitingNot Applicable
Anxiety and Surgery Satisfaction for Cataract Patient With Different State Anxiety
Taiwan400 participantsStarted 2024-01-02
Plain-language summary
This study aims to explore the effects of anxiety traits on pain, anxiety, and anesthesia satisfaction in patients undergoing cataract surgery under topical anesthesia. On the day of recruitment, patients will complete the BAI, STAI-S, and STAI-T anxiety questionnaires to assess baseline anxiety levels. Thirty minutes before the surgery, patients will be randomly assigned, in a double-blind manner, to receive either Xanax or a placebo and will retake the BAI, STAI-S, and STAI-T questionnaires. After the surgery, patients' pain levels and anesthesia satisfaction will be evaluated, with the pain scale and satisfaction survey repeated the following day. The results will analyze the relationship between anxiety traits and pharmacological interventions on the surgical experience, aiming to optimize surgical procedures and improve overall patient comfort.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Age between 18 and 80 years old.
. Patients diagnosed with cataracts.
. Scheduled for cataract surgery with phacoemulsification and intraocular lens implantation under surface anesthesia at National Taiwan University Hospital.
. No adverse reactions to oral anti-anxiety medication (XANAX).
Exclusion criteria
. Presence of any contraindications for surgery before the procedure.
. Presence of any contraindications for medication before the procedure.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Beck Anxiety Inventory (BAI)
Timeframe: 1-3 months
2
State-Trait Anxiety Inventory (STAI-S / STAI-T)
Timeframe: 1-3 months
3
Cataract Surgery Records: Surgical Procedure
Timeframe: 1 days
4
Cataract Surgery Records: Surgical Procedure (Intraoperative Monitoring)
Timeframe: 1 days
5
Cataract Surgery Records: Surgical Procedure (Intraoperative Monitoring)
Timeframe: 1 days
6
Cataract Surgery Records: Surgical Procedure (Intraoperative Monitoring)
Timeframe: 1 days
7
Cataract Surgery Records: Pain Scale
Timeframe: 1 days
8
Cataract Surgery Records: Anesthesia Satisfaction Rating Scale
. Inability to provide clear and complete answers to relevant questionnaires, or expression of no preoperative anxiety during the outpatient visit, or scores below 21 on the STAI-S or STAI-T assessment.
. Regular use of anti-anxiety medications, sleeping pills, or analgesics before the procedure.
. Pregnancy or breastfeeding during the preoperative period.
. Severe corneal diseases, overripe cataracts, small pupils, or lens dislocation leading to difficulties in conventional surgery.
. Patients under surface anesthesia who cannot fully cooperate with the surgical procedure.
. Pregnant or uncertain pregnancy status (women under 55 years old to be verbally asked by research team members).