Recruiting

STEIN Protocol

Sponsor:

UCLA

Code:

NCT07715591

Conditions

Cataract

Cataract (Post-operative Cataract Surgery Follow-up)

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Music and Guided Imagery

Control

Music Only

Study Details

Brief summary:

This randomized controlled trial evaluates whether a standardized perioperative neuroplastic intervention: the STEIN Protocol (Strategies and Techniques for Enhancing Integration and Neuroplasticity), consisting of pain neuroscience education, guided imagery, and paced breathing, reduces intraoperative analgesic and anxiolytic requirements.

Secondary outcomes include patient-reported pain, anxiety, satisfaction, and postoperative recovery following cataract surgery.

Reduced intraoperative sedative and analgesic requirements may reflect improved patient comfort and autonomic regulation while minimizing medication-related adverse effects.

Conditions

Cataract

Cataract (Post-operative Cataract Surgery Follow-up)

Study ID

NCT07715591

Start date

Jun 10, 2026

Status verified date

Sep, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Inclusion Criteria:

Adults undergoing elective cataract surgery under topical anesthesia who are able to provide informed consent and complete study procedures.

Exclusion Criteria:

Inability to provide informed consent Inability to comply with study procedures Complex or combined cataract surgery General anesthesia Medical, neurologic, psychiatric, or respiratory conditions interfering with study participation Requirement for modified anesthetic protocols Inability to complete postoperative breathing exercises or follow-up assessments

Study Design

Enrollment

300 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

placebo comparator: Control

experimental: Music + Guided Imagery

Music and Guided Imagery

experimental: Music Only

Music Only

Interventions

Music and Guided Imagery

Participants wear open-ear headphones during cataract surgery. Every 3 minutes, a voice will ask if the patient would like more relaxing medication or pain medication.

Participants receive the STEIN Protocol, consisting of preoperative pain neuroscience education, intraoperative audio-guided paced breathing and guided imagery, and postoperative home breathing exercises.

The open-ear headphones allow participants to hear and communicate with the surgeon and operating room staff at all times. The audio may be stopped at any time if requested or clinically indicated. No additional medications or medical procedures are administered as part of the intervention, and all other aspects of surgical and anesthetic care remain unchanged.

Control

Participants wear open-ear headphones during cataract surgery. Every 3 minutes, a voice will ask if the patient would like more relaxing medication or pain medication.

Music Only

Participants wear open-ear headphones during cataract surgery. Every 3 minutes, a voice will ask if the patient would like more relaxing medication or pain medication.

Participants receive the music protocol, consisting of preoperative pain neuroscience education, intraoperative music, and postoperative home breathing exercises.

The open-ear headphones allow participants to hear and communicate with the surgeon and operating room staff at all times. The audio may be stopped at any time if requested or clinically indicated. No additional medications or medical procedures are administered as part of the intervention, and all other aspects of surgical and anesthetic care remain unchanged.

Primary outcome measure

  • Total cumulative intraoperative dose of anxiolytic and analgesic medications (midazolam [mg], fentanyl [mcg], and additional rescue medications, recorded separately). [ Time Frame: From initiation of surgery until completion of surgery. ]

Central Contacts and Locations

Central contacts

Shawn R Lin, MD, MS, MBA

310-206-7955slin@jsei.ucla.edu

Locations

Stein Eye Institute - University of California Los Angeles

Recruiting

Los Angeles, California, United States, 90025

Contacts

Shawn R Lin, MD, MS, MBA

310-206-7955slin@jsei.ucla.edu

Principal Investigator:

Shawn R Lin, MD, MS, MBA

More Information

Sponsor

University of California, Los Angeles

Last update posted

Oct 2, 2026

Last verified

Sep, 2026

Keywords

  • Cataract Surgery
  • Pain Neuroscience Education
  • Guided Imagery
  • Guided Breathing
  • Perioperative Care
  • Anxiety
  • Patient Satisfaction
  • Mind-Body Medicine
  • Meditation
  • Breathwrok
  • Pain

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-23. This information was provided to ClinicalTrials.gov by University of California, Los Angeles on 2026-10-02. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.