About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Parallel
Treatments tested in this trial
Music and Guided Imagery
DeviceParticipants 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
DeviceParticipants 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
DeviceParticipants 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.
Treatment groups
Trial outcomes
Primary outcomes
Total cumulative intraoperative dose of anxiolytic and analgesic medications (midazolam [mg], fentanyl [mcg], and additional rescue medications, recorded separately).
Secondary outcomes
Iowa Satisfaction with Anesthesia Scale (ISAS)
Validated clinical survey instrument
Numeric Rating Scale pain score (0-10)
Validated clinical survey instrument
Amsterdam Preoperative Anxiety and Information Scale (APAIS)
Validated clinical survey instrument
Additional questions
Investigator-developed exploratory questionnaire evaluating perceived comfort, communication, perceived control, and overall surgical experience.
Sponsors and contacts
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