Randomized Controlled Trial of the STEIN Protocol: A Neuroplastic Pain Education and Guided Breathing Intervention During Awake Cataract Surgery (SLin)
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.
Studienübersicht
Status
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Geschätzt)
Phase
- Unzutreffend
Kontakte und Standorte
Studienkontakt
- Name: Shawn R Lin, MD, MS, MBA
- Telefonnummer: 310-206-7955
- E-Mail: slin@jsei.ucla.edu
Studienorte
-
-
California
-
Los Angeles, California, Vereinigte Staaten, 90025
- Rekrutierung
- Stein Eye Institute - University of California Los Angeles
-
Kontakt:
- Shawn R Lin, MD, MS, MBA
- Telefonnummer: 310-206-7955
- E-Mail: slin@jsei.ucla.edu
-
Hauptermittler:
- Shawn R Lin, MD, MS, MBA
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Kind
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Doppelt
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Placebo-Komparator: Kontrolle
|
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.
|
|
Experimental: Music + Guided Imagery
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. |
|
Experimental: 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. |
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
|---|---|
|
Total cumulative intraoperative dose of anxiolytic and analgesic medications (midazolam [mg], fentanyl [mcg], and additional rescue medications, recorded separately).
Zeitfenster: From initiation of surgery until completion of surgery.
|
From initiation of surgery until completion of surgery.
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Iowa Satisfaction with Anesthesia Scale (ISAS)
Zeitfenster: Within 30 minutes of surgery completion
|
Validated clinical survey instrument
|
Within 30 minutes of surgery completion
|
|
Numeric Rating Scale pain score (0-10)
Zeitfenster: Within 30 minutes of surgery completion
|
Validated clinical survey instrument
|
Within 30 minutes of surgery completion
|
|
Amsterdam Preoperative Anxiety and Information Scale (APAIS)
Zeitfenster: 30 minutes prior to surgery
|
Validated clinical survey instrument
|
30 minutes prior to surgery
|
|
Additional questions
Zeitfenster: 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
|
Mitarbeiter und Ermittler
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
- Neurologische Manifestationen
- Psychische Störungen
- Augenkrankheiten
- Linsenkrankheiten
- Pathologische Zustände, Anzeichen und Symptome
- Verhalten
- Anzeichen und Symptome
- Therapietreue und Compliance
- Gesundheitsverhalten
- Schmerzen
- Angststörungen
- Katarakt
- Patientenzufriedenheit
- Therapeutika
- Mind-Body-Therapien
- Komplementäre Therapien
- Psychotherapie
- Verhaltensdisziplinen und Aktivitäten
- Bilder, Psychotherapie
Andere Studien-ID-Nummern
- IRB-25-2639
Plan für individuelle Teilnehmerdaten (IPD)
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Beschreibung des IPD-Plans
IPD-Sharing-Zeitrahmen
IPD-Sharing-Zugriffskriterien
Art der unterstützenden IPD-Freigabeinformationen
- STUDIENPROTOKOLL
- SAFT
- ICF
- CSR
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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