Health TrialsbyHealthPanel

Anxiety and Surgery Satisfaction for Cataract Patient With Different State Anxiety

ConditionsOral AnxiolyticPhacoemulsificationCataract SurgerySatisfaction SurveyState Anxiety
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorNational Taiwan University Hospital

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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).

Disqualifiers

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.

Trial design

Design model

Crossover

Treatments tested in this trial

  • Xanax

    Drug

    double-blind randomized controlled clinical trial: in a double-blind manner, to receive Xanax

  • placebo tablets

    Other intervention

    double-blind randomized controlled clinical trial: in a double-blind manner, to receive a placebo (identical in appearance to Xanax but without any active effects)

Treatment groups

400 Participants
are divided into 2 treatment groups
Group A: XanaxExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Beck Anxiety Inventory (BAI)

The Beck Anxiety Inventory (BAI) is a psychological scale specifically designed to assess symptoms of anxiety. The Chinese version has been translated and adapted for Chinese-speaking users. The inventory consists of 21 items covering physiological and cognitive anxiety symptoms, such as palpitations, breathlessness, and tension. Each item is rated on a 4-point scale (0 to 3) based on the frequency or severity of symptoms, with a total score range of 0 to 63. Higher scores indicate more severe anxiety. The BAI demonstrates strong reliability and validity, making it suitable for clinical diagnosis, psychological assessment, and research purposes. It helps clinicians and researchers quickly understand an individual's anxiety levels and evaluate intervention effectiveness.

Time frame
1-3 months
2

State-Trait Anxiety Inventory (STAI-S / STAI-T)

The State-Trait Anxiety Inventory (STAI) is a psychological assessment tool designed to measure anxiety levels, focusing on state anxiety (SA) and trait anxiety (TA). The Chinese version has been translated and culturally adapted for Chinese-speaking users. The inventory comprises 40 items, with 20 items assessing state anxiety and 20 items assessing trait anxiety. Each item is rated on a 4-point scale (1 to 4), resulting in a total score range of 20 to 80 for both SA and TA. Higher scores indicate more severe anxiety. The STAI is widely recognized for its strong reliability and validity, making it suitable for clinical diagnosis, psychological assessment, and research purposes. It is particularly valuable in evaluating the effectiveness of interventions and understanding anxiety characteristics and trends across different populations.

Time frame
1-3 months
3

Cataract Surgery Records: Surgical Procedure

Anesthesia Type: Peribulbar, Topicalanesthesia Incision Area: Corneal, Limbal, Scleral. Incision Location: O'clock position. Cumulative Dissipated Energy (CDE): % / second. Total Surgical Time: Minutes. Phacoemulsifi cation Technique: Phaco-chop, Stop and chop, Divide and conquer. IOL Type:Toric, Non-toric. Capsular Tension Ring (CTR) Use: Yes, No. Suture Presence: Yes, No. Zonular Laxity: Yes, No. Degree of Fixation Loss: Perfect, Fair, Not cooperative, Severedeviation. Number of Abnormal Head or Body Movements. Surgical Complications:Capsular rupture, Vitreous loss, Hyphema, Iris prolapse, Others (specify).

Time frame
1 days
4

Cataract Surgery Records: Surgical Procedure (Intraoperative Monitoring)

Oxygen saturation (%).

Time frame
1 days

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

National Taiwan University Hospital

Lead sponsor

Source ClinicalTrials.gov
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