Using Mindfulness in an Enhanced Recovery After Surgery Protocol to Support Recovery After Colorectal Surgery: A Single Center RCT Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Percentage of participants who completed all mindfulness interventions as measured by study logs
研究概览
简要总结
This study teaches participants who are having colorectal surgery how to use mindfulness to feel calmer and manage pain better. Participants will be randomized (like a flip of a coin) into one of two groups: Mindfulness Intervention or Standard Treatment. Those in the Mindfulness group will have a 30-minute Zoom session before surgery to learn simple mindfulness exercises like deep breathing, using senses, and staying focused on the present.
On the day after surgery, participants will watch a short video review of the mindfulness exercises.
Regardless of the group assigned, participants may be asked to complete questionnaires, and some participants will be asked to complete a semi-structured interview via Zoom, about 2 weeks to 1 month after surgery. Additionally, access to the mindfulness curriculum will be provided to those not randomized to that group. Investigators will collect information such as age, surgery details, pain levels, and pain medication usage. Participants will also fill out surveys before and after surgery to assess physical and mental well-being. All personal information will be kept safe, and interviews or Zoom sessions will be deleted after notes are taken without names attached.
Participants will be in this study for about 4 weeks.
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
- •Patients scheduled for a bowel resection and enrolled in the UH Institutional ERAS pathway
- •Patients will be admitted to the inpatient hospital for at least one day postoperatively
- •Aged 18 or older
- •Receiving surgery at designated University Hospitals locations (Cleveland Medical Center, Ahuja, St. John's Medical Center)
- •English-speaking
- •Access to the internet via phone, laptop, or iPad
排除标准
- •Surgery for palliative purposes only
- •Surgery for ostomy take-down only
- •Discharged on day of surgery
- •History of substance use disorder
- •Allergy or intolerance to all opioids
- •Insufficient English proficiency
- •No access to the internet outside clinical settings
- •Significant visual, hearing or cognitive impairment
研究组 & 干预措施
Mindfulness Intervention
Those in the Mindfulness Intervention group will have a 30-minute Zoom session before surgery to learn simple mindfulness exercises like deep breathing, using senses, and staying focused on the present. After surgery, these participants will receive a refresher on the mindfulness curriculum and complete daily text message check-ins. Prior to surgery and after surgery, participants will also complete questionnaires.
干预措施: Mindfulness Intervention (Behavioral)
Standard Care
Participants will undergo standard of care protocols prior to and after surgery, with no specific intervention related to the study protocol. After surgery, these participants will complete daily text message check-ins. Prior to surgery and after surgery, participants will also complete questionnaires.
结局指标
主要结局
Percentage of participants who completed all mindfulness interventions as measured by study logs
时间窗: Up to one year
次要结局
- Percentage of participants who complete all study questionnaires/text message reminders as measured by study logs(Up to one year)
研究者
Emily Steinhagen
Associate Professor
University Hospitals Cleveland Medical Center