Recruiting

Ketamine & Positive Imagery Therapy

Sponsor:

Mercy Health Ohio

Code:

NCT04746079

Conditions

Procedural Sedation

Emergence Delirium

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Positive Imagery Therapy

Study Details

Brief summary:

The purpose of this study is to determine if positive imagery therapy while using ketamine in procedural sedation reduces the number of emergence reactions and impacts pre and post-procedural anxiety.

Conditions

Procedural Sedation

Emergence Delirium

Study ID

NCT04746079

Start date

Feb 5, 2021

Status verified date

May, 2022

Completion date

Feb, 2023

Anticipated

Primary completion date

Feb, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • at least 18 years of age
  • requires procedural sedation in the emergency department for whom ketamine is selected by the provider as the medication for procedural sedation

Exclusion Criteria:

  • age below 18 years of age
  • any patient with a contraindication to the use of ketamine for the procedural sedation
  • any prisoners
  • pregnant females

Study Design

Enrollment

180 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Positive Imagery Therapy

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\*\*

no intervention: Control

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

Interventions

Positive Imagery Therapy

Perform procedural sedation with slow push of ketamine, 1.5mg/kg, over thirty seconds while reading the Positive Imagery Therapy.

Primary outcome measure

  • Richmond Agitation Sedation Score (RASS) for those receiving procedural sedation with and without ketamine [ Time Frame: From beginning of ketamine administration until patient returns to baseline. Estimated less than 1 hour. ]
  • Pittsburgh Agitation Score for those receiving procedural sedation with and without ketamine [ Time Frame: From beginning of ketamine administration until patient returns to baseline. Estimated less than 1 hour. ]

Central Contacts and Locations

Central contacts

Locations

Mercy Health St Elizabeth Youngstown

Recruiting

Youngstown, Ohio, United States, 44504

Contacts

More Information

Sponsor

Mercy Health Ohio

Last update posted

Sep 23, 2022

Last verified

May, 2022

Keywords

  • ketamine

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mercy Health Ohio on 2022-09-23.