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Mind over scalpel: could guided breathing replace sedatives during eye surgery?

NCT ID NCT07715591

Symptom relief Sponsor: University of California, Los Angeles Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 20, 2026 · Last updated Jul 24, 2026 · Updated 3 times

Summary

This trial tests whether a combination of pain education, guided imagery, and paced breathing—called the STEIN Protocol—can help people undergoing awake cataract surgery need less pain and anxiety medication. Participants wear open-ear headphones that play audio prompts every few minutes, asking if they want more relaxing or pain medication, while still being able to hear the surgical team. The study compares this approach to standard care in 300 adults to see if it improves comfort and reduces drug-related side effects.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
a perioperative neuroplastic intervention called the STEIN Protocol, combining pain neuroscience education, guided imagery, and paced breathing
What this could lead to
If effective, this drug-free approach could reduce reliance on sedatives and painkillers during cataract surgery, lowering side effects and improving patient comfort.
What could go wrong
This is a relatively small, early-stage trial, and the intervention may not significantly reduce medication needs or improve outcomes for all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 300 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2026

Expected to finish

Sep 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

anxiety disorder cataract Pain Patient Satisfaction

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cataract Cataract (post-operative cataract surgery follow-up)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Stein Eye Institute - University of California Los Angeles

    RECRUITING

    Los Angeles, California, 90025, United States

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