An interventional study of Music and Guided Imagery and Control in Cataract and Cataract (Post-operative Cataract Surgery Follow-up), sponsored by University of California, Los Angeles. Recruiting at 1 site in United States. Per ClinicalTrials.gov, last updated 2026-10-02.
Sponsored by University of California, Los Angeles · Not applicable, Interventional, and Treatment
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.
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.
1,629 studies on the registry are indexed under Cataract; 235 are open to participants now.
This study's planned enrollment of 300 is above the median of 79 across 1,092 interventional studies indexed under Cataract.
Browse Cataract studies →University of California, Los Angeles is the lead sponsor of 1,170 studies on the registry; 195 are open to participants now.
Of its 95 completed or terminated interventional studies of FDA-regulated products, 70 (74%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Adults undergoing elective cataract surgery under topical anesthesia who are able to provide and complete study procedures.
Exclusion Criteria:
Inability to provide 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
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Device: Control
Music and Guided Imagery
Device: Music and Guided Imagery
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 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.
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 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.
Total cumulative intraoperative dose of anxiolytic and analgesic medications (midazolam [mg], fentanyl [mcg], and additional rescue medications, recorded separately).
Time frame: From initiation of surgery until completion of surgery.
Iowa Satisfaction with Anesthesia Scale (ISAS)
Validated clinical survey instrument
Time frame: Within 30 minutes of surgery completion
Numeric Rating Scale pain score (0-10)
Validated clinical survey instrument
Time frame: Within 30 minutes of surgery completion
Amsterdam Preoperative Anxiety and Information Scale (APAIS)
Validated clinical survey instrument
Time frame: 30 minutes prior to surgery
Additional questions
Investigator-developed exploratory questionnaire evaluating perceived comfort, communication, perceived control, and overall surgical experience.
Time frame: Within 30 minutes after surgery completion
Plan to share: Yes — De-identified individual participant data, study protocol, statistical analysis plan, informed consent form, and supporting study documents will be made available upon reasonable request following publication, subject to institutional review and IRB requirements.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Time frame: After publication for 1 year
Access criteria: The researcher can email the study PI to obtain the IPD.
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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