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

RECRUITINGN/ASponsored by University of California, Los Angeles
Actively Recruiting
PhaseN/A
SponsorUniversity of California, Los Angeles
Started2026-06-10
Est. completion2026-09-01
Eligibility
Healthy vol.Accepted
Locations1 site
View on ClinicalTrials.gov →

NCT07715591

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.

Eligibility

Healthy volunteers 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

Conditions3

AnxietyCataractCataract (Post-operative Cataract Surgery Follow-up)

Locations1 site

Stein Eye Institute - University of California Los Angeles
Los Angeles, California, 90025
Shawn R Lin, MD, MS, MBA310-206-7955slin@jsei.ucla.edu

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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