Enhancing Quality of Patient Experience Via an Innovative Reduction of Pre-Operative Anxiety
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Pre-operative anxiety (PROMIS Anxiety scale)
研究概览
简要总结
This clinical trial tests how well guided meditation, compared to silence, works to reduce pre-operative anxiety in patients undergoing cancer-directed surgery. Pre-operative anxiety affects patient experience and has been found to be a predictor of severe post-operative pain and chronic pain after surgery, influencing the success and quality of a patient's recovery. While medication is often prescribed to improve anxiety symptoms, research has showed that mindfulness techniques can be used to decrease anxiety, improve comfort, and can impact both psychological and physiologic symptoms. Completing pre-operative guided meditation may work well to reduce pre-operative anxiety in patients undergoing cancer directive surgery.
详细描述
PRIMARY OBJECTIVE:
I. To improve is pre-operative patient anxiety in surgical settings.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients listen to 10 minutes of guided meditation prior to surgery.
ARM II: Patients wear noise cancelling headphones for 10 minutes prior to surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- 否
入选标准
- •Participants will be recruited among patients who are scheduled for cancer-directed surgery
- •Participants must be 18 years or older
排除标准
- •Participants will be excluded from the study if they cannot speak English (as the meditation is recorded in English)
- •Currently incarcerated
- •Have a diagnosis of dementia
- •Are admitted to the intensive care unit (ICU)
- •Have a hearing impairment that would make them unable to hear the recorded meditation
研究组 & 干预措施
Arm I (guided meditation)
Patients listen to 10 minutes of guided meditation prior to surgery.
干预措施: Survey Administration (Other)
Arm I (guided meditation)
Patients listen to 10 minutes of guided meditation prior to surgery.
干预措施: Behavioral Intervention (Behavioral)
Arm I (guided meditation)
Patients listen to 10 minutes of guided meditation prior to surgery.
干预措施: Electronic Health Record Review (Other)
Arm II (noise cancelling headphones)
Patients wear noise cancelling headphones for 10 minutes prior to surgery.
干预措施: Behavioral Intervention (Behavioral)
Arm II (noise cancelling headphones)
Patients wear noise cancelling headphones for 10 minutes prior to surgery.
干预措施: Electronic Health Record Review (Other)
Arm II (noise cancelling headphones)
Patients wear noise cancelling headphones for 10 minutes prior to surgery.
干预措施: Survey Administration (Other)
结局指标
主要结局
Pre-operative anxiety (PROMIS Anxiety scale)
时间窗: Pre and post intervention, approximately 10 minutes
Measured with the Patient Reported Outcome Measurement Information System Anxiety. PROMIS Anxiety short form is an 8-item scale used to assess anxiety in individuals 18 years or older. Each item is on a 5-point scale to be summed, with higher scores indicating greater anxiety.
Pre-operative anxiety (single-item visual analog scale)
时间窗: Pre and post intervention, approximately 10 minutes
Measured by a single-item visual analog scale. The single-item visual analog scale will be used to assess momentary anxiety. The item will ask, "On a scale of 1 to 10, how anxious do you feel right now?" and patients will rate the level of anxiety on a scale of 0 to 10 (0=not at all anxious, 10=extremely anxious).
次要结局
- Length of stay(Up to 6 months post intervention)
- Post-operative opiate use(Up to 6 months post intervention)
- Post-operative morphine equivalent dose(Up to 6 months post intervention)
- Post-operative average daily morphine(Up to 6 months post intervention)
研究者
Maryanna Klatt
Principal Investigator
Ohio State University Comprehensive Cancer Center