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临床试验/NCT02165280
NCT02165280已完成不适用

Guided IMagery and Patient Satisfaction Following Urogynecological Surgery

Loyola University2 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2014年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
44
试验地点
2
主要终点
Change in patient satisfaction with urogynecological surgery when using GIM (questionnaire)

研究概览

简要总结

We hypothesize that women who use GIM pre-operatively will feel more prepared for surgery, have less anxiety on the day of surgery and have higher satisfaction scores 6 weeks after surgery compared to women who undergo our routine pre-operative care.

详细描述

Guided imagery (GIM) is a program of directed thoughts and suggestions that guide your imagination to a relaxed and focused state. In clinical settings, it was originally found effective in treating patients suffering primarily from emotional or psychological issues by using descriptive language and the five senses to help the patient visualize their desired change or outcome (1, 2). More recently, GIM has been incorporated into chemotherapy and surgical settings. While it has not been conclusively found to improve outcomes, patients who received GIM reported feeling less anxious, less nausea following chemotherapy, slightly shorter surgical recovery times and a higher quality of life (3-8). While these studies suggest exciting prospects for the incorporation of GIM into the normal pre-op routine, we believe that they have left out one integral piece of the puzzle. We have previously found that patients who feel "unprepared" for surgery have less post-operative satisfaction (9). We propose that the stress and anxiety of the unknown during a patient's surgical experience can make them feel unprepared for surgery. Therefore, the same techniques that have been previously shown to decrease these symptoms in chemotherapy treatment and surgery should help patients feel more prepared, and therefore more satisfied with their surgical experience. This key finding would give sufficient support for the incorporation of GIM into the pre-op routine of any surgical patient, and may prove to be a successful vehicle for increasing the overall satisfaction of any hospital's patient population.

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
21 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • routine vaginal or laparoscopic surgery for pelvic organ prolapse planned ≥ 1 week from enrollment
  • a planned overnight hospital stay
  • commitment to listen to a 15 minute audio Compact Disc daily
  • proficiency in English.

排除标准

  • Not having routine vaginal or laparoscopic surgery for pelvic organ prolapse planned ≥ 1 week from enrollment
  • Not a planned overnight hospital stay
  • Unable to commitment to listen to a 15 minute audio Compact Disc daily
  • Not proficiency in English.

研究组 & 干预措施

Guided IMagery (GIM)

Active Comparator

If randomized to GIM, they will then be given an audio Compact Disc. Patients will be instructed to listen to the recording least once per day in a calm location during the week leading up to surgery. They will then be seen prior to surgery in the surgical waiting area where they will evaluated for anxiety, preparedness and study compliance.

干预措施: Guided IMagery (GIM) (Behavioral)

Standard of Care (SOC)

No Intervention

Each participant will complete a baseline set of questionnaires. The Pelvic Floor Distress Inventory (PFDI) is a 20 question self-administered questionnaire on the presence and both of pelvic floor symptoms .

The Pelvic Organ Prolapse Quantification System (POPQ) measures the topography of the vagina and is considered to be gold standard for quantifying prolapse .

The State-Trait Anxiety Inventory (STAI) has been used extensively in research and clinical practice since its introduction in 1966 and is the most widely cited measure of anxiety.

New measurements at the 6-week follow-up appointment will include the Patient Global Impression of Improvement (PGII), and a postoperative questionnaire eliciting overall satisfaction and development of new pelvic symptoms.

结局指标

主要结局

Change in patient satisfaction with urogynecological surgery when using GIM (questionnaire)

时间窗: 6 weeks

Women will report their satisfaction with their surgical experience 6 weeks after surgery using a 10-point Likert scale.

次要结局

  • Change in patient anxiety about surgery when using GIM (questionnaire)(6 week)
  • Change in patient sense of preparedness when using GIM (questionnaire)(6 weeks)

研究者

发起方
Loyola University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Elizabeth Mueller

M.D. Assistant Professor

Loyola University

研究点 (2)

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