A Pilot Study to Assess the Feasibility of a Randomized Control Trial Employing a Single-arm Intervention, at a Single Institution, to Study the Effects of Combined Self-induced Therapeutic Tremors Plus Mindfulness on Symptoms of Chronic Pelvic Pain.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Feasibility of the pilot trial
研究概览
简要总结
To collect pilot data and assess the feasibility of a trial employing a single-arm intervention to study the effects of combined self-induced therapeutic tremors plus mindfulness on symptoms of chronic pelvic pain among women diagnosed with chronic pelvic pain.
详细描述
The estimated prevalence of chronic pelvic pain among women is 2-24%. The etiology of chronic pelvic pain is multifactorial making it very difficult to manage clinically. Evidenced-based therapies are limited and a multidisciplinary approach, including complementary and alternative medicine, to treat women with chronic pelvic pain may be the best approach. This study assess the feasibility of conducting randomized controlled trial with a single arm intervention to treat symptoms of chronic pelvis pain among women diagnosed with chronic pelvic pain. The intervention will consist of a novel combined alternative therapy intervention among women with chronic pelvic pain (self-induced therapeutic tremor plus mindfulness). This is a clinically significant project as lifestyle interventions to treat chronic pelvic pain are urgently needed, given the prevalence and the healthcare costs associated with chronic pelvic pain.
Study Objective: The primary purpose of this project is to collect pilot data and assess the feasibility of a single arm intervention trial to improve symptoms of CPP among women diagnosed with CPP.
Intervention Arm - Combined Alternative Therapy: The novel combined alternative therapy that will be studied consists of self-induced therapeutic tremors (SITT) plus mindfulness. SITT is the intentional induction of the body's innate tremor mechanism to treat hyperarousal and muscle tension, which is characteristic of CPP. SITTs are thought to restore somatic and autonomic nervous system homeostasis, by discharging sympathetic arousal and down-regulating the autonomic nervous system. Previous work has shown that mindfulness training may improve symptoms of CPP, however there are no studies investigating the impact that the combination of mindfulness coupled with SITTs may have on the symptoms of CPP.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Physical requirements: be able to complete the intervention sessions
- •Not seeking other therapeutic modalities, such as acupuncture, PT, during study duration
- •Free from surgery for >3 months
- •being treated clinically for chronic pelvic pain and related conditions
- •CPP of 6 months or more (to be considered chronic)
- •Availability to commit to the 4-week intervention (two 60-minute sessions per week at a specified time, for 4 weeks)
- •Internet access and consistent access to phone/email/text communication
排除标准
- •Pregnancy
- •Illicit substance use (e.g. cocaine, methamphetamines, heroin, street drugs) - marijuana and CBD oil and related supplements will be considered on a case-by-case basis by the principal investigators
- •Current psychiatric illness/social situation that would limit compliance with study requirements, as determined by the principal investigators
结局指标
主要结局
Feasibility of the pilot trial
时间窗: This will be assessed at the completion of the study, approximately 1-1.5 years after the study start.
To determine feasibility, the investigators will assess if it is possible to recruit, enroll, and have complete follow-up with participants. If the recruitment goal is met and 80% compliance with study visit attendance is achieved, the trial will be classified as feasible (yes/no classification).
次要结局
- Change in Anxiety(Pre- Program, Immediately Post-Program, and 1 Month Follow Up)
- Change in Fatigue(Pre- Program, Immediately Post-Program, and 1 Month Follow Up)
- Change in Sleep Disturbance(Pre- Program, Immediately Post-Program, and 1 Month Follow Up)
- Change in Physical Function(Pre- Program, Immediately Post-Program, and 1 Month Follow Up)
- Change in Depression(Pre- Program, Immediately Post-Program, and 1 Month Follow Up)
- Change in Ability to Participant in Social Roles and Activities(Pre- Program, Immediately Post-Program, and 1 Month Follow Up)
- Change in Pain Intensity(Pre- Program, Immediately Post-Program, and 1 Month Follow Up)