Study of STEIN Protocol for Cataract Surgery
This study is testing a new approach called the STEIN Protocol during awake cataract surgery. The STEIN Protocol includes education about pain, guided imagery, and paced breathing. Researchers want to see if this protocol can reduce the amount of relaxing medication (midazolam) and pain medication (fentanyl) you might need during surgery. You would wear open-ear headphones during surgery, and a voice would ask every 3 minutes if you need more medication. The study is for adults having elective cataract surgery. We don't know the current recruitment status.
- Study design
- This is a randomized controlled trial planning to enroll 300 participants. Participants will be assigned to one of three groups: STEIN Protocol, Music Only, or a Control group.
- What's involved
- Participants will receive preoperative pain neuroscience education, intraoperative audio-guided paced breathing or music, and practice brief breathing exercises at home for one week after surgery.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary outcome measures medication use from the start to the completion of surgery. Postoperative recovery is also a secondary outcome.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Randomized Controlled Trial of the STEIN Protocol: A Neuroplastic Pain Education and Guided Breathing Intervention During Awake Cataract Surgery
At a glance
Conditions
Where it's being run
1 sites across 1 statesWho to contact
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What this trial measures
- 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.