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

Mercy Health Ohio

Status: Unknown

Conditions: Emergence Delirium; Procedural Sedation

Treatments: Behavioral: Positive Imagery Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT04746079

20-025

Details and patient eligibility

About

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.

Full description

This is a multi-center, randomized controlled trial looking at if positive imagery therapy while using ketamine during procedural sedation will reduce the number of emergence reactions and impacts pre and post procedural anxiety. After informed consent has been established and the subject is determined to meet eligibility criteria, participants will be randomized into 2 groups. The interventional group will undergo positive imagery therapy during sedation and the control will not. The duration of subject participation will be from the onset of sedation beginning until the patient is recovered.

Enrollment: 180 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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180 participants in 2 patient groups

Positive Imagery Therapy

Experimental group

Description:

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\*\*

Treatment:

Behavioral: Positive Imagery Therapy

Control

No Intervention group

Description:

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