Anxiety and Surgery Satisfaction for Cataract Patient With Different State Anxiety

Pain, Anxiety and Anesthetic Satisfaction for Patient With Different State Anxiety Underwent Cataract Surgery With Topical Anesthesia

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.

Study Overview

• Status: Recruiting
• Conditions: Cataract Surgery; Phacoemulsification; State Anxiety; Oral Anxiolytic; Satisfaction Survey
• Intervention / Treatment: Drug: Xanax; Other: placebo tablets

Detailed Description

BACKGROUNDS Nowadays, phacoemulsification for cataract treatment is the most common surgical procedure performed and anesthetics procedure has been shifted from retrobulbar or peribulbar anesthesia to topical anesthesia (TA). Phacoemulsification under TA is proved to be a safe and low risk procedure with the incidence of adverse events requiring medical emergency team interventions to be 0.04%. However, it is not uncommon that patients can suffer from pain, anxiety and unpleasant visual sensation during this procedure. Complementary sedation has long been thought to alleviate the anxiety and pain of the patient during surgery with local anesthesia. Studies revealed that approximate one fourth of the patients underwent phacoemulsification under TA or retrobulbar anesthesia requested additional intravenous sedation of midazolam. However, the intravenous sedation, such as midazolam, propofol, or etomidate, increase the risk of additional anesthetic complications of heart rate, blood pressure, body temperature, and nausea, and therefore, anesthesia monitoring was mandatory during the surgery.

Compared with intravenous sedation, oral sedation is less costly and less invasive. Studies with different oral sedation agents revealed different effect. In the study of 41 patients serving themselves as control, patients reported more pain and photophobia in the surgery with TA alone than the other with midazolam syrup and oral transmucosal fentanyl citrate. However, two studies comparing oral diazepam or triazolam with intravenous midazolam showed similar rate of anxiety and pain or noninferior satisfaction. Moreover, the randomized control trial containing 50 procedures in each groups revealed that patients received TA alone during phacoemulsification reported similar pain or anxiety level to those received complementary intravenous midazolam.

• Study Type: Interventional
• Enrollment (Estimated): 400
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Chiun Ho Hou, Ph.D; Phone Number: 262131 +88623123456; Email: chiunhohou@gmail.com

Study Locations

• Taiwan
  • Taiwan
    • Taipei, Taiwan, Taiwan, 100
      • Recruiting
      • National Taiwan University Hospital
      • Contact: Chiun Ho Hou, Ph.D; Phone Number: 262131 +88623123456; Email: chiunhohou@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Age between 18 and 80 years old.
2. Patients diagnosed with cataracts.
3. Scheduled for cataract surgery with phacoemulsification and intraocular lens implantation under surface anesthesia at National Taiwan University Hospital.
4. No adverse reactions to oral anti-anxiety medication (XANAX).

Exclusion Criteria:

1. Presence of any contraindications for surgery before the procedure.
2. Presence of any contraindications for medication before the procedure.
3. 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.
4. Regular use of anti-anxiety medications, sleeping pills, or analgesics before the procedure.
5. Pregnancy or breastfeeding during the preoperative period.
6. Severe corneal diseases, overripe cataracts, small pupils, or lens dislocation leading to difficulties in conventional surgery.
7. Patients under surface anesthesia who cannot fully cooperate with the surgical procedure.
8. Pregnant or uncertain pregnancy status (women under 55 years old to be verbally asked by research team members).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Other: placebo tablets; 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); Other Names: placebo
Experimental: Xanax	Drug: Xanax; double-blind randomized controlled clinical trial: in a double-blind manner, to receive Xanax

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 2, 2024
• Primary Completion (Estimated): September 11, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: December 12, 2024
• First Submitted That Met QC Criteria: February 9, 2025
• First Posted (Actual): February 14, 2025

Study Record Updates

• Last Update Posted (Actual): April 23, 2026
• Last Update Submitted That Met QC Criteria: April 21, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Cataract surgery; Phacoemulsification; State Anxiety; Satisfaction survey; Oral anxiolytic
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Benzazepines; Benzodiazepines; Alprazolam
• Other Study ID Numbers: 202302067MINB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No