## Protocol Section
### Identification Module
**NCT ID:** NCT04746079

**Brief Title:** Positive Imagery Therapy and the Incidence of Emergence Reactions With the Use of Ketamine

**Official Title:** Positive Imagery Therapy and the Incidence of Emergence Reactions With the Use of Ketamine

#### Organization Study ID Info
**ID:** 20-025
#### Organization
**Class:** OTHER
**Full Name:** Mercy Health Ohio
### Status Module
#### Completion Date
**Date:** 2023-02

**Type:** ESTIMATED

#### Expanded Access Info
**Last Known Status:** RECRUITING
#### Last Update Post Date
**Date:** 2022-09-23

**Type:** ACTUAL

**Last Update Submit Date:** 2022-09-22

**Overall Status:** UNKNOWN

#### Primary Completion Date
**Date:** 2023-02

**Type:** ESTIMATED

#### Start Date
**Date:** 2021-02-05

**Type:** ACTUAL

**Status Verified Date:** 2022-05

#### Study First Post Date
**Date:** 2021-02-09
**Type:** ACTUAL
**Study First Submit Date:** 2021-02-08
**Study First Submit QC Date:** 2021-02-08
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** Lake Erie College of Osteopathic Medicine

#### Lead Sponsor

**Class:** OTHER

**Name:** Mercy Health Ohio

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**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.

**Detailed 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.

### Conditions Module

**Conditions:**

- Procedural Sedation

- Emergence Delirium

**Keywords:**

- ketamine

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

**Intervention Model Description:** The sealed envelope method.

##### Masking Info

**Masking:** NONE

**Primary Purpose:** PREVENTION

#### Enrollment Info

**Count:** 180

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**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\*\*

**Intervention Names:**

- Behavioral: Positive Imagery Therapy

**Label:** Positive Imagery Therapy

**Type:** EXPERIMENTAL

#### Arm Group 2

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

**Label:** Control

**Type:** NO_INTERVENTION

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Positive Imagery Therapy

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

**Name:** Positive Imagery Therapy

**Type:** BEHAVIORAL

### Outcomes Module

#### Primary Outcomes

**Description:** RASS score measured is -5 to +4. A lower score indicates someone is more alert, calm, drowsy indicating the patient has no emergence reaction. Higher score indicates an emergence reaction occurred.

**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.

**Description:** PAS is measures from 0-16. A lower score indicated no agitation or emergence reaction while a higher score does.

**Measure:** 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.

### Eligibility Module

**Eligibility Criteria:** 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

**Healthy Volunteers:** True

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** tbolotin@gmail.com

**Name:** Todd Bolotin, MD

**Phone:** (330) 219-3838

**Role:** CONTACT

**Contact 2:**

**Email:** kprokopakis32@gmail.com

**Name:** Kayla Prokopakis, DO

**Phone:** (740) 512-8498

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Youngstown

**Contacts:**

***Contact 1:***

- **Email:** tbolotin@gmail.com

- **Name:** Todd Bolotin, MD

- **Phone:** 330-219-3838

- **Role:** CONTACT

***Contact 2:***

- **Email:** chad.donley@alteonhealth.com

- **Name:** Chad Donley, MD

- **Phone:** 740-607-6318

- **Role:** CONTACT

**Country:** United States

**Facility:** Mercy Health St Elizabeth Youngstown

**State:** Ohio

**Status:** RECRUITING

**Zip:** 44504

#### Overall Officials

**Official 1:**

**Affiliation:** Bon Secours Mercy Health

**Name:** Todd Bolotin, MD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

### References Module

#### References

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**PMID:** 20970888

**Citation:** Akhlaghi N, Payandemehr P, Yaseri M, Akhlaghi AA, Abdolrazaghnejad A. Premedication With Midazolam or Haloperidol to Prevent Recovery Agitation in Adults Undergoing Procedural Sedation With Ketamine: A Randomized Double-Blind Clinical Trial. Ann Emerg Med. 2019 May;73(5):462-469. doi: 10.1016/j.annemergmed.2018.11.016. Epub 2019 Jan 3.

**PMID:** 30611640

**Citation:** Stoker AD, Rosenfeld DM, Buras MR, Alvord JM, Gorlin AW. Evaluation of Clinical Factors Associated with Adverse Drug Events in Patients Receiving Sub-Anesthetic Ketamine Infusions. J Pain Res. 2019 Dec 23;12:3413-3421. doi: 10.2147/JPR.S217005. eCollection 2019.

**PMID:** 31920366

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**PMID:** 27281730

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**PMID:** 10692189

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**PMID:** 18723707

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**PMID:** 18660398

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**PMID:** 19501426

**Citation:** Treston G, Bell A, Cardwell R, Fincher G, Chand D, Cashion G. What is the nature of the emergence phenomenon when using intravenous or intramuscular ketamine for paediatric procedural sedation? Emerg Med Australas. 2009 Aug;21(4):315-22. doi: 10.1111/j.1742-6723.2009.01203.x.

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**PMID:** 25271180

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000003693

- Term: Delirium

- ID: D000003221

- Term: Confusion

- ID: D000019954

- Term: Neurobehavioral Manifestations

- ID: D000009461

- Term: Neurologic Manifestations

- ID: D000009422

- Term: Nervous System Diseases

- ID: D000019965

- Term: Neurocognitive Disorders

- ID: D000001523

- Term: Mental Disorders

- ID: D000011183

- Term: Postoperative Complications

- ID: D000010335

- Term: Pathologic Processes

### Condition Browse Module - Browse Branches

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M772

- Name: Emergence Delirium

- Relevance: HIGH

- As Found: Emergence Delirium

- ID: M6894

- Name: Delirium

- Relevance: LOW

- As Found: Unknown

- ID: M6446

- Name: Confusion

- Relevance: LOW

- As Found: Unknown

- ID: M21826

- Name: Neurobehavioral Manifestations

- Relevance: LOW

- As Found: Unknown

- ID: M12404

- Name: Neurologic Manifestations

- Relevance: LOW

- As Found: Unknown

- ID: M21836

- Name: Neurocognitive Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M4815

- Name: Mental Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M14473

- Name: Psychotic Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M14065

- Name: Postoperative Complications

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000071257

- Term: Emergence Delirium

### Intervention Browse Module - Browse Branches

- Abbrev: Analg

- Name: Analgesics

- Abbrev: CNSDep

- Name: Central Nervous System Depressants

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: HB

- Name: Herbal and Botanical

### Intervention Browse Module - Browse Leaves

- ID: M10674

- Name: Ketamine

- Relevance: LOW

- As Found: Unknown

- ID: T119

- Name: Coconut

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24
