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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorUniversity of California, Los Angeles

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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.

  • 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.

Treatment groups

300 Participants
are divided into 3 treatment groups
Group A: ControlPlacebo comparator 1 intervention
Group B: Music + Guided ImageryExperimental treatment 1 intervention
Group C: Music OnlyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Secondary outcomes

1

Iowa Satisfaction with Anesthesia Scale (ISAS)

Validated clinical survey instrument

Time frame
Within 30 minutes of surgery completion
2

Numeric Rating Scale pain score (0-10)

Validated clinical survey instrument

Time frame
Within 30 minutes of surgery completion
3

Amsterdam Preoperative Anxiety and Information Scale (APAIS)

Validated clinical survey instrument

Time frame
30 minutes prior to surgery
4

Additional questions

Investigator-developed exploratory questionnaire evaluating perceived comfort, communication, perceived control, and overall surgical experience.

Time frame
Within 30 minutes after surgery completion

Other outcomes

Sponsors and contacts

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