Randomized Controlled Trial of the STEIN Protocol: A Neuroplastic Pain Education and Guided Breathing Intervention During Awake Cataract Surgery
University of California, Los Angeles
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.
Description
The STEIN Protocol is a randomized behavioral intervention designed to evaluate whether standardized, non-pharmacologic interventions can help patients have a more comfortable and safe surgical experience. Cataract surgery provides a highly standardized operative model with minimal procedural variability, making it well suited for evaluating perioperative behavioral interventions while minimizing confounding from surgical complexity. The intervention is based on contemporary models of pain neuroscience, which propose that cognitive appraisal, expectancy, autonomic regulation, and attentional…
Eligibility
- Age range
- Not specified
- Sex
- All
- Healthy volunteers
- No
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
Interventions
- DeviceMusic 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.
- DeviceControl
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.
- DeviceMusic 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.
Location
- Stein Eye Institute - University of California Los AngelesLos Angeles, California