Anxiety and Surgery Satisfaction for Cataract Patient With Different State Anxiety

NCT ID: NCT06826417

Last Updated: 2025-11-18

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-02
• Study Completion Date: 2026-12-31

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.

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Xanax

Group Type: EXPERIMENTAL

Xanax

Intervention Type: DRUG

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

Placebo

Group Type: PLACEBO_COMPARATOR

placebo tablets

Intervention Type: 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)

Interventions

Xanax

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

Intervention Type: DRUG

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)

Intervention Type: OTHER

Other Intervention Names

placebo

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Taiwan University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

National Taiwan University Hospital

Taipei, Taiwan, Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Chiun Ho Hou, Ph.D

Role: CONTACT

chiunhohou@gmail.com

+88623123456 ext. 262131

Facility Contacts

Chiun Ho Hou, Ph.D

Role: primary

chiunhohou@gmail.com

+88623123456 ext. 262131

Other Identifiers

202302067MINB

Identifier Type: -

Identifier Source: org_study_id