Positive Imagery Therapy and the Incidence of Emergence Reactions With the Use of Ketamine
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Pittsburgh Agitation Score for those receiving procedural sedation with and without ketamine
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •age below 18 years of age
- •any patient with a contraindication to the use of ketamine for the procedural sedation
- •any prisoners
- •pregnant females
研究组 & 干预措施
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**
干预措施: Positive Imagery Therapy (Behavioral)
Control
Perform procedural sedation with slow push of ketamine, 1.5mg/kg, over thirty seconds with no positive imagery therapy.
结局指标
主要结局
Pittsburgh Agitation Score for those receiving procedural sedation with and without ketamine
时间窗: From beginning of ketamine administration until patient returns to baseline. Estimated less than 1 hour.
PAS is measures from 0-16. A lower score indicated no agitation or emergence reaction while a higher score does.
Richmond Agitation Sedation Score (RASS) for those receiving procedural sedation with and without ketamine
时间窗: From beginning of ketamine administration until patient returns to baseline. Estimated less than 1 hour.
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.
次要结局
未报告次要终点