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临床试验/NCT04773925
NCT04773925已完成不适用

The Impact of Integrative Medicine on Patient-Reported Outcomes in Management of Chronic Pelvic Pain

Mayo Clinic2 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2021年3月23日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
Mayo Clinic
入组人数
15
试验地点
2
主要终点
Number of participants with improved quality of life scores on PROMIS-CAT questionnaires after treatment of chronic pelvic pain and enrollment in a mind-body training program

研究概览

简要总结

The purpose of this research is to determine if mind and body counseling and training improves quality of life in women undergoing treatment for chronic pelvic pain.

详细描述

Patients with chronic illnesses are expected to self-manage much of their treatment. Barriers include limited time during appointments, consultations with multiple different providers, technical communication style, health literacy issues, and a sense of feeling overwhelmed. Patients with chronic pain syndromes experience symptoms which can negatively impact their quality of life by interfering with ability to sleep, work, and function in their social roles. One proposed mechanism in chronic pain management is mindfulness. Mindfulness is the intentional and non-judgmental conscious awareness of the present moment, or "paying attention on purpose" with the goal of physical and psychological health improvement. Participants are taught autonomy, increasing self-regulation, and focusing awareness on a particular goal or activity.

The investigators hypothesize that a mind-body counselor will improve patient engagement and promote adherence to pain coping treatments. If the initial findings from this project support the use of Integrative Medicine services in women with chronic pelvic pain, the investigators hope to expand this study to a larger, randomized controlled trial that is adequately powered to determine significant difference among participants in the control and study groups.

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 89 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Clinical diagnosis of chronic pelvic pain.
  • Must speak English.
  • Must be ages 18 through
  • Must be willing and able to provide informed consent for participation.
  • Must have access to the Patient Online Services portal to complete the questionnaires.

排除标准

  • Diagnoses of primarily non-gynecologic pain, acute pelvic pain, and active abdominal or pelvic malignancy.

结局指标

主要结局

Number of participants with improved quality of life scores on PROMIS-CAT questionnaires after treatment of chronic pelvic pain and enrollment in a mind-body training program

时间窗: 6 months

This outcome measure will demonstrate whether the proposed intervention showed improvement in symptomatology of subjects with chronic pain.

次要结局

  • Number of participants who were able to attend all mind-body training sessions(6 months)
  • Time from enrollment in the study until completion of all mind-body sessions(6 months)

研究者

发起方
Mayo Clinic
申办方类型
Other
责任方
Principal Investigator
主要研究者

Aakriti R. Carrubba

Principal Investigator

Mayo Clinic

研究点 (2)

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