Clinical trial Recruiting at 1 site Interventional

Neuroplastic pain education and guided breathing during awake cataract surgery

Official title: Randomized Controlled Trial of the STEIN Protocol: A Neuroplastic Pain Education and Guided Breathing Intervention During Awake Cataract Surgery

Run by University of California, Los Angeles · NCT07715591 · Data updated 2026-11-12

This trial tests whether the STEIN Protocol, a non-drug approach with pain education, guided imagery, and paced breathing, helps adults having cataract surgery require less pain medicine and feel less anxious.

More Cataract trials

Quick facts

Study typeInterventional
SexAll
Enrollment300 (estimated)
SponsorUniversity of California, Los Angeles
Academic / other
Locations1 site (Los Angeles, California)
StatusRecruiting
StartedJune 10, 2026
Main results expectedDecember 31, 2026
Study endsDecember 31, 2026
Registry record updatedOctober 2, 2026
Trial IDNCT07715591 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults undergoing elective cataract surgery with topical anesthesia who can consent and participate in the protocol.

Probably not a fit

Patients who cannot perform breathing exercises, have contraindications to the intervention, or require general anesthesia may not benefit.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

In this randomized trial, adults undergoing elective cataract surgery under topical anesthesia are assigned to receive the STEIN Protocol or standard care. The STEIN Protocol includes a preoperative educational video, guided breathing during the procedure, and post–surgery breathing exercises, aiming to reduce sympathetic arousal and improve pain control. Outcomes include intraoperative analgesic and anxiolytic use, patient-reported pain and anxiety, satisfaction, and recovery. The study leverages the standardized nature of cataract surgery to evaluate a behavioral, non-pharmacologic intervention and compares groups to assess feasibility and impact on perioperative experience.

Why it matters

Potential benefit: If successful, patients may experience less pain and anxiety during surgery with lower reliance on sedatives and analgesics, along with improved recovery.

How similar studies have gone: Prior work in perioperative care suggests non-pharmacologic interventions can reduce anxiety and pain, with this trial testing a structured neuroplastic approach.

Who can join: the full rules

Show full inclusion / exclusion criteria
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

Where it's running

  • Stein Eye Institute - University of California Los Angeles
    Los Angeles, California, United States
    Recruiting

Study contacts

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.