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Oral AnxiolyticNCT06826417

Anxiety and Surgery Satisfaction for Cataract Patient With Different State Anxiety

A study testing Xanax in people with Oral Anxiolytic and Phacoemulsification, run by National Taiwan University Hospital at 1 site in Taiwan.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 yearsHealthy volunteers can take part
What is being tested?
Xanax
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
400 participants
Where
1 siteTaiwan
Study dates
2 Jan 2024to 31 Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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).

Who cannot join

  • 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).

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Taiwan1 site, 1 recruiting
  • National Taiwan University Hospital

    Taipei, Taiwan, 100

    Chiun Ho Hou, Ph.D, +88623123456 ext. 262131, chiunhohou@gmail.com

    Recruiting

Other trials in Taiwan

About this study

Official title: 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.

Read the 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.

Being tested
Xanax, placebo tablets
Keywords
Oral anxiolytic, Phacoemulsification, Cataract surgery, Satisfaction survey, State Anxiety
Medical subject headings
Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • XanaxDrug

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

  • placebo tabletsOther

    Also called placebo

    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)

Study groups in NCT06826417
Study groupRoleWhat they receive
XanaxExperimentalNot described
Receives: Drug: Xanax
PlaceboPlacebo comparatorNot described
Receives: Other: placebo tablets

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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.

    Measured: 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).

    Measured: 1 days

  4. Cataract Surgery Records: Surgical Procedure (Intraoperative Monitoring)

    Oxygen saturation (%).

    Measured: 1 days

  5. Cataract Surgery Records: Surgical Procedure (Intraoperative Monitoring)

    Blood pressure (mmHg).

    Measured: 1 days

  6. Cataract Surgery Records: Surgical Procedure (Intraoperative Monitoring)

    Heart rate (bpm).

    Measured: 1 days

  7. 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.

    Measured: 1 days

  8. 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.

    Measured: 1 days

  9. 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.

    Measured: 1 days

  10. Postoperative Follow-Up (Postoperative Symptoms)

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

    Measured: 1 days

  11. 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.

    Measured: 1 days

  12. 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.

    Measured: 1 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Feb 2025
  2. Study start2 Jan 2024
  3. Primary completion11 Sep 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Crossover
Model description
Double-blind randomized controlled trial.
Masking
None (open label)
Enrolment
400 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06826417
Sponsor's protocol ID
202302067MINB
Status last verified
Apr 2026
First submitted
12 Dec 2024
Last updated
23 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing Xanax in people with Oral Anxiolytic and Phacoemulsification, run by National Taiwan University Hospital at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Chiun Ho Hou, Ph.D (+88623123456 ext. 262131, chiunhohou@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Beck Anxiety Inventory (BAI) (time frame: 1-3 months). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2026.

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