Cataract, Cataract (Post-operative Cataract Surgery Follow-up)
Conditions
Keywords
Cataract Surgery, Pain Neuroscience Education, Guided Imagery, Guided Breathing, Perioperative Care, Anxiety, Patient Satisfaction, Mind-Body Medicine, Meditation, Breathwrok, Pain
Brief 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.
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.
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.
Sponsors
University of California, Los Angeles
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, 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.
Intervention model description
Participants undergoing cataract surgery will be randomly assigned in a parallel-group design to one of three study arms: 1. Standard care (no audio intervention) 2. Music Protocol, relaxing music 3. STEIN Protocol, relaxing music and audio-guided paced diaphragmatic breathing 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.
Eligibility
Sex/Gender
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total cumulative intraoperative dose of anxiolytic and analgesic medications (midazolam [mg], fentanyl [mcg], and additional rescue medications, recorded separately). | From initiation of surgery until completion of surgery. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Iowa Satisfaction with Anesthesia Scale (ISAS) | Within 30 minutes of surgery completion | Validated clinical survey instrument |
| Numeric Rating Scale pain score (0-10) | Within 30 minutes of surgery completion | Validated clinical survey instrument |
| Amsterdam Preoperative Anxiety and Information Scale (APAIS) | 30 minutes prior to surgery | Validated clinical survey instrument |
| Additional questions | Within 30 minutes after surgery completion | Investigator-developed exploratory questionnaire evaluating perceived comfort, communication, perceived control, and overall surgical experience. |
Countries
United States
Contacts
CONTACTShawn R Lin, MD, MS, MBA
Outcome results
None listed