Brief Video-Based Mindful Movement Intervention Prior to Pelvic Exams
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Visual Analogue Scale - Pain 2
研究概览
简要总结
This study endeavors to implement a brief video-based mindfulness intervention within a clinic setting for women undergoing pelvic examinations, in hopes of reducing state anxiety and pain intensity during pelvic exams and improving overall exam satisfaction and likelihood to return for follow-up exams. This will be a pilot study will take place the University of Texas Southwestern (UTSW) Lowe Foundation Center for Women's Preventative Health Care. There will be a treatment and a control arm, estimated 50 women per group.
详细描述
Participants will be randomly assigned to either a treatment group or a control group. Treatment group will receive a 5-minute mindful movement video-based intervention before their previously scheduled pelvic exam. Control group will not receive the mindful movement video-based intervention and will instead be given a handout about the benefits of mindfulness to read prior to the pelvic exam. Control group will be given access to the mindfulness intervention via an online link upon completion of participation in the study to ensure they are provided the opportunity to benefit from mindfulness practice.
Participants will be recruited from a group of female patients at the Lowe Foundation Center who have already been scheduled for an upcoming pelvic exam. Therefore the pelvic exam procedure itself is standard of care, the experimental piece is the mindfulness intervention before the pelvic exam - either the video, or the written educational materials depending on whether participants are randomly assigned to the treatment or control group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
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
- •Age of 18+ years
- •Scheduled physical evaluation including pelvic exam at UT Southwestern's Lowe Foundation Center for Women's Preventative Health Care.
排除标准
- •Participants who are unable to read, speak, write or understand verbally spoken English
- •Participants who are blind or otherwise visually impaired will be excluded due to nature of video intervention.
- •Participants who are pregnant will be excluded from the study.
- •Individuals presenting to the clinic for an acute pain reason will be excluded from the study.
结局指标
主要结局
Visual Analogue Scale - Pain 2
时间窗: immediately after the procedure
Using an iPad, participant slides a bar on a scale to the right or left to indicate level of pain. All the way to the right indicates highest pain (100) all the way to the left indicates no pain (0). Higher number indicates worse outcome/more pain.
Visual Analogue Scale - Anxiety 1 (Change in Anxiety)
时间窗: baseline, pre-intervention/procedure
Using an iPad, participant slides a bar on a scale to the right or left to indicate level of anxiety. All the way to the right indicates highest anxiety (100) all the way to the left indicates no anxiety (0). Higher number indicates worse outcome/more anxiety.
Visual Analogue Scale - Anxiety 3 (Change in Anxiety)
时间窗: immediately after the procedure
Using an iPad, participant slides a bar on a scale to the right or left to indicate level of anxiety. All the way to the right indicates highest anxiety (100) all the way to the left indicates no anxiety (0). Higher number indicates worse outcome/more anxiety.
Visual Analogue Scale - Anxiety 2 (Change in Anxiety)
时间窗: immediately after the intervention
Using an iPad, participant slides a bar on a scale to the right or left to indicate level of anxiety. All the way to the right indicates highest anxiety (100) all the way to the left indicates no anxiety (0). Higher number indicates worse outcome/more anxiety.
Visual Analogue Scale - Pain 1
时间窗: baseline, pre-intervention
Using an iPad, participant slides a bar on a scale to the right or left to indicate level of pain. All the way to the right indicates highest pain (100) all the way to the left indicates no pain (0). Higher number indicates worse outcome/more pain.
次要结局
- Physician Experience Survey(immediately after the procedure)
- Mindfulness Perceptions Survey(immediately after the procedure)
- Exam Satisfaction Survey(immediately after the procedure)
- Patient Health Questionnaire (PHQ-9)(baseline, pre-intervention/procedure)
研究者
Tracy Greer
Associate Professor, Department of Psychiatry
University of Texas Southwestern Medical Center