Mindful Movement and Breathing to Improve Outcomes of Gynecologic Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Feasibility of implementing and evaluating a Mindful Movement and Breathing Program among women undergoing gynecologic surgery for a suspected malignancy (recruitment, retention, adherence, and program evaluation and acceptability rates)
研究概览
简要总结
The purpose of this clinical trial is to understand if women undergoing surgery for a suspected gynecologic malignancy are interested in participating in a Mindful Movement and Breathing program and what the effects of this program are on women and the surgery-related symptoms they experience. Mindful Movement and Breathing programs may be effective for easing distress, post-surgical pain, and other symptoms of surgical procedures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- Female
- 接受健康志愿者
- 否
入选标准
- •Signed protocol specific informed consent
- •18 years of age or older
- •Scheduled for a major abdominal gynecological surgery to remove a mass that is suspected to be malignant
排除标准
- •Unable to read or understand English
- •Cognitively impaired and/or cannot complete interviews as judged by the referring physician, nurse, or study staff
研究组 & 干预措施
Mindful Movement and Breathing program
Mindful Movement and Breathing program implemented in a hospital room or clinic room three times by a yoga instructor: prior to surgery, one day and two days after surgery.
干预措施: Mindful Movement and Breathing program (Other)
Mindful Movement and Breathing program
Mindful Movement and Breathing program implemented in a hospital room or clinic room three times by a yoga instructor: prior to surgery, one day and two days after surgery.
干预措施: Questionnaire administration (Other)
Mindful Movement and Breathing program
Mindful Movement and Breathing program implemented in a hospital room or clinic room three times by a yoga instructor: prior to surgery, one day and two days after surgery.
干预措施: The Observer Mobility Scale (Procedure)
Mindful Movement and Breathing program
Mindful Movement and Breathing program implemented in a hospital room or clinic room three times by a yoga instructor: prior to surgery, one day and two days after surgery.
干预措施: Volumetric Incentive Spirometry (Procedure)
结局指标
主要结局
Feasibility of implementing and evaluating a Mindful Movement and Breathing Program among women undergoing gynecologic surgery for a suspected malignancy (recruitment, retention, adherence, and program evaluation and acceptability rates)
时间窗: 4-5 days
The proportion of participants who participated in all YST sessions and those who completed all assessments will be computed and compared to those with incomplete data by demographic characteristics. We will model the relationship between adherence and baseline scores of the measures, as well as change in scores. We will also calculate the proportions and 95% confidence intervals of the items that measure program evaluation and intervention to the Clinical Studies Coordinator, nurses and yoga instructor.
次要结局
- Immediate effects of the Mindful Movement and Breathing program on reducing postsurgical pain, psychological distress and lung function(4-5 days)
- Collect data on measures that will be used to evaluate the efficacy of the Mindful Movement and Breathing program in a future larger randomized controlled trial(4-5 days)