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

Description

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.

Interventions

• Music and Guided Imagery (Device)
  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.
• Control (Device)
  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.
• Music Only (Device)
  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.

Eligibility criteria

Conditions

Locations

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