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
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Placebo Comparator Control |
|
|
|
Experimental Music + Guided Imagery |
Music and Guided Imagery |
|
|
Experimental Music Only |
Music Only |
|
Recruiting Locations
Los Angeles, California 90025
More Details
- Status
- Recruiting
- Sponsor
- University of California, Los Angeles
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.