Anxiety and Surgery Satisfaction for Cataract Patient With Different State Anxiety

NCT06826417 | Recruiting

• 1 other identifier: 202302067MINB
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Phacoemulsification; Cataract Surgery; State Anxiety; Oral Anxiolytic; Satisfaction Survey

Keywords

Oral anxiolytic; Phacoemulsification; Cataract surgery; Satisfaction survey; State Anxiety

Outcome Measures

Primary Outcomes (12)

• 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.

  1-3 months

• 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.

  1-3 months

• 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).

  1 days

• Cataract Surgery Records: Surgical Procedure (Intraoperative Monitoring)

  Oxygen saturation (%).

  1 days

• Cataract Surgery Records: Surgical Procedure (Intraoperative Monitoring)

  Blood pressure (mmHg).

  1 days

• Cataract Surgery Records: Surgical Procedure (Intraoperative Monitoring)

  Heart rate (bpm).

  1 days

• Cataract Surgery Records: Pain Scale

  Surgical Outcome: Initial outcomes immediately after surgery, including corneal clarity, IOL positioning, and patient reaction. Complication Management: Actions taken to address any intraoperative complications, such as hemostatic measures or additional medication. Pain Assessment: Documentation of immediate postoperative pain levels and pain management interventions.

  1 days

• Cataract Surgery Records: Anesthesia Satisfaction Rating Scale

  The anesthesia satisfaction rating scale evaluates patients' satisfaction with the anesthesia experience during surgical procedures, focusing on factors such as pain management, comfort, and communication with the anesthesia team. The scales typically use a numerical rating system, such as a 10-point scale, where higher scores indicate greater satisfaction. These tools are simple and effective for assessing patients' perspectives on specific aspects of their care. The results are valuable for optimizing clinical procedures, improving patient experiences, and enhancing the quality of medical services.

  1 days

• Postoperative Follow-Up

  Bulbar Injection: 0, 1, 2, 3, 4. Anterior Chamber Reaction (AC Reaction): 0, 1, 2, 3,4. Corneal Edema: 0, 1, 2, 3, 4. Intraocular Pressure (mmHg) (IOP): ≤21, \>21. bulbar injection(0 to 4 +) (0) no injection; (1) very slight; (2) slight; (3) moderate; (4) severe. Anterior chamberreaction (cell 0 to 4+) in a 1 x 1 mm slit-lamp beam (0) No cells; (1+) 5-10 cells ; (2+)11-20 cells ;(3+) 21-50 cells ; (4+) \>50 cells.

  1 days

• Postoperative Follow-Up (Postoperative Symptoms)

  None; Fatigue; Ataxia; Dizziness; Headache; Urinary retention; Amnesia; Muscle weakness; Nausea; Confusion; Disorientation; Restlessness; Others (specify).

  1 days

• Postoperative Satisfaction Pain Scale

  The pain scale is a tool for assessing patients' subjective perceptions of pain, widely used in clinical and research settings. It typically employs numerical ratings (e.g., 0-10) or a Visual Analog Scale (VAS), where 0 represents no pain and 10 represents the most severe pain. Patients select a score based on their experience, quantifying their pain levels in a straightforward manner. This tool is commonly used in postoperative, chronic pain, or acute pain management, helping healthcare providers quickly understand patients' pain conditions and adjust treatment plans accordingly. With its simplicity and high reliability, the pain scale is an essential standardized evaluation tool in the medical field.

  1 days

• Postoperative Satisfaction Rating Scale

  The postoperative satisfaction rating scale assesses overall satisfaction with the surgical experience, including pain relief, medical care, and service quality. The scales typically use a numerical rating system, such as a 10-point scale, where higher scores indicate greater satisfaction. These tools are simple and effective for assessing patients' perspectives on specific aspects of their care. The results are valuable for optimizing clinical procedures, improving patient experiences, and enhancing the quality of medical services.

  1 days

Study Arms (2)

Xanax

EXPERIMENTAL

Drug: Xanax

Placebo

PLACEBO COMPARATOR

Other: placebo tablets

Interventions

Xanax DRUG

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

Xanax

placebo tablets OTHER

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)

Also known as: placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.
• 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).

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan, 100, Taiwan

RECRUITING

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Alprazolam

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Central Study Contacts

Chiun Ho Hou, Ph.D

CONTACT

+88623123456; chiunhohou@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Double-blind randomized controlled trial.

Study Record Dates

• First Submitted: December 12, 2024
• First Posted: February 14, 2025
• Study Start: January 2, 2024
• Primary Completion (Estimated): September 11, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 23, 2026

Record last verified: 2026-04

Locations

TW (1)