CataractSLinNCT07715591
Randomized Controlled Trial of the STEIN Protocol: A Neuroplastic Pain Education and Guided Breathing Intervention During Awake Cataract Surgery
A study testing Music and Guided Imagery and Music Only in people with Cataract and Cataract (Post-operative Cataract Surgery Follow-up), run by University of California, Los Angeles at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cataract, Cataract (Post-operative Cataract Surgery Follow-up)
- What is being tested?
- Music and Guided Imagery and Music Only
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jun 2026to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Adults undergoing elective cataract surgery under topical anesthesia who are able to provide informed consent and complete study procedures.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Stein Eye Institute - University of California Los Angeles
Los Angeles, California, 90025
Shawn R Lin, MD, MS, MBA, 310-206-7955, slin@jsei.ucla.edu
Shawn R Lin, MD, MS, MBA
About this study
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.
Read the 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.
- Being tested
- Music and Guided Imagery, Control, Music Only
- Keywords
- Cataract Surgery, Pain Neuroscience Education, Guided Imagery, Guided Breathing, Perioperative Care, Anxiety, Patient Satisfaction, Mind-Body Medicine, Meditation, Breathwrok, Pain
- Medical subject headings
- Cataract, Anxiety Disorders, Patient Satisfaction, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music and Guided ImageryDevice
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.
ControlDevice
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.
Music OnlyDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | Not described Receives: Device: Control |
| Music + Guided Imagery | Experimental | Music and Guided Imagery Receives: Device: Music and Guided Imagery |
| Music Only | Experimental | Music Only Receives: Device: Music Only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total cumulative intraoperative dose of anxiolytic and analgesic medications (midazolam [mg], fentanyl [mcg], and additional rescue medications, recorded separately).
Measured: From initiation of surgery until completion of surgery.
Secondary outcomes (4)
Iowa Satisfaction with Anesthesia Scale (ISAS)
Validated clinical survey instrument
Measured: Within 30 minutes of surgery completion
Numeric Rating Scale pain score (0-10)
Validated clinical survey instrument
Measured: Within 30 minutes of surgery completion
Amsterdam Preoperative Anxiety and Information Scale (APAIS)
Validated clinical survey instrument
Measured: 30 minutes prior to surgery
Additional questions
Investigator-developed exploratory questionnaire evaluating perceived comfort, communication, perceived control, and overall surgical experience.
Measured: Within 30 minutes after surgery completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2026
- Study start10 Jun 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CataractStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shawn R. Lin, MD, MBA, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07715591
- Sponsor's protocol ID
- IRB-25-2639
- Acronym
- SLin
- Status last verified
- Sep 2026
- First submitted
- 15 Jul 2026
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of the STEIN Protocol: A Neuroplastic Pain Education and Guided Breathing Intervention During Awake Cataract Surgery
- ClinicalTrials.gov ID
- NCT07715591
- Acronym / sponsor ID
- SLin / IRB-25-2639
- Keywords
- Cataract Surgery, Pain Neuroscience Education, Guided Imagery, Guided Breathing, Perioperative Care, Anxiety, Patient Satisfaction, Mind-Body Medicine
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- 10 Jun 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 20 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Device: Control |
| Music + Guided Imagery | Experimental | Device: Music and Guided ImageryMusic and Guided Imagery |
| Music Only | Experimental | Device: Music OnlyMusic Only |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Adults undergoing elective cataract surgery under topical anesthesia who are able to provide informed consent and complete study procedures.
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Music and Guided ImageryParticipants 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. | Device | Music + Guided Imagery |
| ControlParticipants 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. | Device | Control |
| Music OnlyParticipants 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. | Device | Music Only |
Primary outcome
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.
4 secondary outcomes
Iowa Satisfaction with Anesthesia Scale (ISAS)
Time frame: Within 30 minutes of surgery completion
Numeric Rating Scale pain score (0-10)
Time frame: Within 30 minutes of surgery completion
Amsterdam Preoperative Anxiety and Information Scale (APAIS)
Time frame: 30 minutes prior to surgery
Additional questions
Time frame: Within 30 minutes after surgery completion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Music and Guided Imagery and Music Only in people with Cataract and Cataract (Post-operative Cataract Surgery Follow-up), run by University of California, Los Angeles at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shawn R Lin, MD, MS, MBA (310-206-7955, slin@jsei.ucla.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026.