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 range18 Years – 80 Years
SexALL
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.
✕. 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.
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