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

Purpose

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.

Conditions

  • Cataract
  • Cataract (Post-operative Cataract Surgery Follow-up)

Eligibility

Eligible Ages
All ages
Eligible Sex
All
Accepts 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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Participants undergoing cataract surgery will be randomly assigned in a parallel-group design to one of two study arms: 1. Standard care (no audio intervention) 2. STEIN Protocol, consisting of standardized audio-guided paced diaphragmatic breathing delivered through open-ear headphones during surgery. Participants complete validated preoperative and postoperative patient-reported outcome measures assessing anxiety, pain, satisfaction, sleep quality, and medication use. The intervention spans the perioperative period and includes preoperative pain neuroscience education, intraoperative audio guidance, and postoperative home breathing exercises. To standardize assessment of intraoperative medication requirements, a prerecorded prompt asks participants every three minutes whether additional analgesia or anxiolysis is desired. Randomization will be performed using a computer-generated block randomization sequence with allocation concealed until study assignment.
Primary Purpose
Treatment
Masking
Double (Care Provider, Investigator)
Masking Description
Surgeons and anesthesia providers will not be informed of treatment allocation before or during surgery. Intervention audio is delivered through open-ear headphones, and participants are instructed not to disclose intervention content. Medication administration follows a standardized patient-directed protocol to minimize the potential influence of treatment allocation.

Arm Groups

ArmDescriptionAssigned Intervention
Placebo Comparator
Control
  • Device: Control
    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.
Experimental
Music + Guided Imagery 		Music and Guided Imagery
  • Device: Music 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.
Experimental
Music Only 		Music Only
  • Device: Music 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.

Recruiting Locations

Stein Eye Institute - University of California Los Angeles
Los Angeles, California 90025
Contact:
Shawn R Lin, MD, MS, MBA
310-206-7955
slin@jsei.ucla.edu

More Details

Status
Recruiting
Sponsor
University of California, Los Angeles

Study Contact

Shawn R Lin, MD, MS, MBA
310-206-7955
slin@jsei.ucla.edu

Detailed 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 processes influence pain perception independent of tissue injury. Participants in the study will receive standard cataract surgery, with some patients also taking part in the STEIN Protocol. This includes watching a short educational video before surgery, following slow, guided breathing during the procedure, and practicing brief breathing exercises at home for one week after surgery. The intervention is designed to reduce sympathetic arousal and promote parasympathetic regulation through standardized paced breathing and guided cognitive attention. The intervention is intended to modify cognitive appraisal, attentional focus, and autonomic regulation, thereby influencing pain perception throughout the perioperative period. The study will compare pain levels, medication use, recovery, and patient satisfaction between groups to determine whether this standardized, scalable approach can improve the surgical experience and potentially benefit patients undergoing many types of surgery in the future. We hypothesize that participants receiving the STEIN Protocol will require less intraoperative anxiolytic and analgesic medication while reporting lower pain, lower anxiety, and greater satisfaction than participants receiving standard care. Surgical technique, anesthetic management, questionnaire administration, and postoperative follow-up will be standardized across study groups. Adherence to each component of the intervention will be documented to assess intervention fidelity.