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Positive Imagery Therapy for Emergence Delirium

N/A

Recruiting

Led By Todd Bolotin, MD

Research Sponsored by Mercy Health Ohio

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from beginning of ketamine administration until patient returns to baseline. estimated less than 1 hour.

Awards & highlights

Study Summary

This trial is testing whether using positive imagery while under ketamine sedation can help reduce anxiety and fearfulness related to the procedure.

Eligible Conditions

Emergence Delirium
Conscious Sedation

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from beginning of ketamine administration until patient returns to baseline. estimated less than 1 hour.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from beginning of ketamine administration until patient returns to baseline. estimated less than 1 hour.

This trial's timeline: 3 weeks for screening, Varies for treatment, and from beginning of ketamine administration until patient returns to baseline. estimated less than 1 hour. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Pittsburgh Agitation Score for those receiving procedural sedation with and without ketamine

Richmond Agitation Sedation Score (RASS) for those receiving procedural sedation with and without ketamine

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Positive Imagery TherapyExperimental Treatment1 Intervention

Perform procedural sedation with slow push of ketamine, 1.5mg/kg, over thirty seconds while reading the Positive Imagery Therapy below: "Relax and close your eyes. Take deep breaths in through your nose and out through your mouth as you listen to the sound of my voice. (Three second pause.) I want you to picture yourself lying on a towel on a soft sandy beach. (Three second pause.) You can see a palm trees swaying in the wind beneath a bright blue sky with a few white puffy clouds. (Three second pause.) You can feel the sand between your toes, the warm sunlight on your skin and a cool breeze. (Three second pause) You can smell coconut lotion in the breeze. (Three second pause.) You can hear the sound of waves gently crashing on the beach and seagulls crying in the distance. **End of vignette**

Group II: ControlActive Control1 Intervention

Perform procedural sedation with slow push of ketamine, 1.5mg/kg, over thirty seconds with no positive imagery therapy.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Lake Erie College of Osteopathic MedicineOTHER

7 Previous Clinical Trials

350 Total Patients Enrolled

Mercy Health OhioLead Sponsor

14 Previous Clinical Trials

1,425 Total Patients Enrolled

Todd Bolotin, MDPrincipal InvestigatorBon Secours Mercy Health

2 Previous Clinical Trials

109 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any open enrollments for this research endeavor?

"Affirmative. According to clinicaltrials.gov, this experiment is actively recruiting participants from one site and aims to enroll 180 individuals in total. This research was initially published on February 5th 2021 and updated most recently on September 22nd 2022."

Answered by AI

How many people are being recruited for participation in this research study?

"Affirmative. The information accessible on clinicaltrials.gov denotes that this experiment is actively seeking participants, having been first posted on February 5th 2021 and recently updated on September 22nd 2022. 180 volunteers are required from a single venue for the trial to be completed successfully."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Positive Imagery Therapy and the Incidence of Emergence Reactions With the Use of Ketamine

2021. "Positive Imagery Therapy and the Incidence of Emergence Reactions With the Use of Ketamine". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04746079.