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

15. juli 2026 opdateret af: Shawn R. Lin, MD, MBA, University of California, Los Angeles

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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

300

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Forenede Stater
    • California
      • Los Angeles, California, Forenede Stater, 90025
        • Rekruttering
        • Stein Eye Institute - University of California Los Angeles
        • Kontakt:
        • Ledende efterforsker:
          • Shawn R Lin, MD, MS, MBA

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn
  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Placebo komparator: Styring
Enhed: Control
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.
Eksperimentel: Music + Guided Imagery
Music and Guided Imagery
Enhed: Music 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.
Eksperimentel: Music Only
Enhed: 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 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Total cumulative intraoperative dose of anxiolytic and analgesic medications (midazolam [mg], fentanyl [mcg], and additional rescue medications, recorded separately).
Tidsramme: From initiation of surgery until completion of surgery.
From initiation of surgery until completion of surgery.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Iowa Satisfaction with Anesthesia Scale (ISAS)
Tidsramme: Within 30 minutes of surgery completion
Validated clinical survey instrument
Within 30 minutes of surgery completion
Numeric Rating Scale pain score (0-10)
Tidsramme: Within 30 minutes of surgery completion
Validated clinical survey instrument
Within 30 minutes of surgery completion
Amsterdam Preoperative Anxiety and Information Scale (APAIS)
Tidsramme: 30 minutes prior to surgery
Validated clinical survey instrument
30 minutes prior to surgery
Additional questions
Tidsramme: Within 30 minutes after surgery completion
Investigator-developed exploratory questionnaire evaluating perceived comfort, communication, perceived control, and overall surgical experience.
Within 30 minutes after surgery completion

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of California, Los Angeles

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

10. juni 2026

Primær færdiggørelse (Anslået)

1. september 2026

Studieafslutning (Anslået)

1. september 2026

Datoer for studieregistrering

Først indsendt

15. juli 2026

Først indsendt, der opfyldte QC-kriterier

15. juli 2026

Først opslået (Faktiske)

20. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

20. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

15. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • IRB-25-2639

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

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.

IPD-delingstidsramme

After publication for 1 year

IPD-delingsadgangskriterier

The researcher can email the study PI to obtain the IPD.

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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