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NCT07715591
Randomized Controlled Trial of the STEIN Protocol: A Neuroplastic Pain Education and Guided Breathing Intervention During Awake Cataract Surgery
Conditions: Cataract, Cataract (Post-operative Cataract Surgery Follow-up)
Sex: All
Healthy volunteers: No
Phase: NA
Enrollment: 300
Sponsor: University of California, Los Angeles
Location: Stein Eye Institute - University of California Los Angeles Los Angeles California
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 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
Source: ClinicalTrials.gov (NCT07715591). StuddyBuddy aggregates publicly available trial information.
