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

Recruiting now · Not applicable

Conditions studied: Cataract, Cataract (Post-operative Cataract Surgery Follow-up)

In brief

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.

Key facts

Study ID: NCT07715591
Run by: University of California, Los Angeles
People needed: 300
Starts: 2026-06-10
Expected to finish: 2026-09-01
Last updated by the study team: 2026-07-23

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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 is running

Stein Eye Institute - University of California Los Angeles — Los Angeles, California, United States (enrolling)

Full record on ClinicalTrials.gov

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