NCT05903638进行中（未招募）不适用
A Pilot RCT: the Impact of a Virtual MBSR Course on Women With Primary Infertility Seeking Fertility Treatment at a Single Centre
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- MBSR course participation rate
研究概览
简要总结
We plan to perform a pilot study in which women with primary infertility seeking an initial fertility consultation will be randomized into either a standard treatment group or an 8-week virtual Mindfulness-Based Stress Reduction (MBSR) program. Primary outcomes included retention and survey completion rates. Secondary outcomes included Beck Depression Inventory (BDI), Beck Anxiety Inventory (BAI), Perceived Stress Score (PSS), Fertility Problem Index (FPI), pregnancy rates, intention to pursue treatment and % pursuing treatment.
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
- Triple (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Primary infertility and no prior fertility treatment
排除标准
- •No internet access
- •Non-English speaking
- •History of suicidal ideation/intent, psychotic disorder, eating disorder, substance abuse or dependence, PTSD
- •Psychotropic medication change in the previous month
- •Previously seen at another fertility clinic
- •Previous MBSR course
- •Previous mindfulness meditation retreat
结局指标
主要结局
MBSR course participation rate
时间窗: 8-weeks of MBSR course
Survey completion rate
时间窗: Randomization to 3-months after course completion
次要结局
- Perceived Stress Scale(Randomization to 3-months after course completion)
- % involvement in fertility treatment(3-months after course completion)
- Beck Depression Inventory(Randomization to 3-months after course completion)
- Beck Anxiety Inventory(Randomization to 3-months after course completion)
- Fertility Problem Inventory(Randomization to 3-months after course completion)
- Pregnancy rates(3-months after course completion)
研究者
研究点 (2)
Loading locations...
相似试验
已完成
不适用
Online Mind/Body Program for FertilityInfertilityNCT03343405University of Vermont71
Unknown
不适用
Pilot Study to Assess Feasibility, Reliability and Validity of the e-SSRS-IVRHealthyNCT00921466Rogers Center for Research & Training, Inc.20
已完成
不适用
Feasibility Trial of an Online Course (eMB) to Reduce Anxiety and Depression for Pregnant Women and Their PartnersAnxiety Disorders GeneralizedDepressionNCT05867680University of Missouri-Columbia60
已完成
不适用
Implementing a Pilot Patient Navigator Program to Improve Access to Infertility Care for Underserved PatientsInfertilityNCT06481319Boston Medical Center28
已完成
不适用
Virtual Exercise for Multiple MyelomaMultiple MyelomaNCT04484714University of Alberta31