Randomized Controlled Trial of the STEIN Protocol: A Neuroplastic Pain Education and Guided Breathing Intervention During Awake Cataract Surgery

NCT07715591 | Recruiting DMC

• 1 other identifier: IRB-25-2639
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Cataract; Cataract (Post-operative Cataract Surgery Follow-up)

Keywords

Cataract Surgery; Pain Neuroscience Education; Guided Imagery; Guided Breathing; Perioperative Care; Anxiety; Patient Satisfaction; Mind-Body Medicine; Meditation; Breathwrok; Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Iowa Satisfaction with Anesthesia Scale (ISAS)

  Within 30 minutes of surgery completion

• Numeric Rating Scale pain score (0-10)

  Within 30 minutes of surgery completion

• Amsterdam Preoperative Anxiety and Information Scale (APAIS)

  30 minutes prior to surgery

• Additional questions

  Within 30 minutes after surgery completion

Study Arms (3)

Control

PLACEBO COMPARATOR

Device: Control

Music + Guided Imagery

EXPERIMENTAL

Music and Guided Imagery

Device: Music and Guided Imagery

Music Only

EXPERIMENTAL

Music Only

Device: Music Only

Interventions

Control DEVICE

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.

Control

Music Only DEVICE

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.

Music Only

Music and Guided Imagery DEVICE

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.

Music + Guided Imagery

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults undergoing elective cataract surgery under topical anesthesia who are able to provide informed consent and complete study procedures.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Los Angeles: lead

Study Sites (1)

Stein Eye Institute - University of California Los Angeles

Los Angeles, California, 90025, United States

RECRUITING

MeSH Terms

Conditions

Cataract; Anxiety Disorders; Patient Satisfaction; Pain

Interventions

Imagery, Psychotherapy

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases; Mental Disorders; Treatment Adherence and Compliance; Health Behavior; Behavior; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Psychotherapy; Behavioral Disciplines and Activities

Central Study Contacts

Shawn R Lin, MD, MS, MBA

CONTACT

310-206-7955; slin@jsei.ucla.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Clinical Professor of Ophthalmology

Model Details: 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.

Study Record Dates

• First Submitted: July 15, 2026
• First Posted: July 20, 2026
• Study Start: June 10, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: July 23, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: After publication for 1 year
• Access Criteria: The researcher can email the study PI to obtain the IPD.

Locations

US (1)