The Effect of Guided Imagery and Music Therapy on Post-Operative Recovery After Gynecological Oncology Surgery
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Change in Mean Pain Score
研究概览
简要总结
This pilot study will be a prospective, randomized trial which will take place at the University of Minnesota Medical Center (UMMC). Eligible patients will be identified at the time of their first clinic visit. If selected to be involved in the study, the patients will be randomized to one of three different groups: a Guided Imagery and Music therapy group (GIMT) or one of two control groups.
详细描述
The GIMT group will undergo a standardized regimen of peri-operative guided imagery and music therapy guided by CDs. As there are no studies which discuss whether the act of listening to any therapy will affect outcomes, we will also explore whether white noise can affect outcomes as well. Therefore, one control group (WN) will abide by the same regimen and will listen to a CD with white noise; the other control group (CP) will have no intervention at all and will follow our current peri-operative procedures.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Subjects will include women who are being seen at the Women's Health Center by the Gynecological Oncology group at the University of Minnesota (UMMC). These women will be considered for inclusion based on their projected surgery: exploratory laparotomy. Subjects will have to have their surgery at the UMMC within 1 month of their clinic visit. Patients may be undergoing surgery for either known cancer (ovarian or uterine) or high suspicion for malignancy.
排除标准
- •< 19 years old
- •undergoing a procedure other than laparotomy
- •scheduled to be discharged the same day of surgery
- •chronic narcotic pain medication users
- •if they are currently using or planning on using other complementary alternative medicine (CAM) therapies prior to or after surgery.
结局指标
主要结局
Change in Mean Pain Score
时间窗: From Admission through 4 Weeks Post Surgery
Determined by using a Visual Analog Pain Scale (VAS)- A Visual Analogue Scale (VAS) for pain is a horizontal line 100 mm in length with the left end labeled 'No pain' and the right end labeled 'Very severe pain'. The subject marks a point on the line that represents their perception of their current state. The VAS score is determined by measuring the distance from the left end of the line to the point on the line marked by the subject. The range of possible values for this pain score is 0 to 100 millimetres.
次要结局
- Mean Change in Patient Quality of Life Score(From Admission to 4 Weeks Post Surgery)
- Length of Hospital Stay (Days)(From Admission through 4 Weeks Post Surgery)
- Average Number of Days Hospitalized(From Admission through 4 Weeks Post Surgery)
- Use of Pain Medication(From Admission to 4 Weeks Post Surgery)
- Use of Anti-Nausea Medications(From Admission to 4 Weeks Post Surgery)
- Hospital Readmission Rates(From Admission Through 4 Weeks Post Surgery)
- Change in Profile of Mood States (POMS)(From Admission Through 4 Weeks Post Surgery)