Impact of Mindfulness Based Stress Reduction on Anxiety, Depression and Quality of Life in Women With Intrauterine Adhesion:a Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 226
- 主要终点
- The Zung Self-Rating Anxiety Scale Scores Before and After the Intervention
研究概览
简要总结
The purpose of this study is to determine whether mindfulness based stress reduction are effective on improve anxiety, depression and quality of life in women with intrauterine adhesion
详细描述
This is a parallel arm, randomized controlled trials, according to 1: 1 ratio assigned intrauterine adhesions patients to mindfulness based stress reduction group and wait-list control group.The study compared anxiety and depression levels and quality of life in patients with intrauterine adhesions before and after the completion of mindfulness based stress reduction program.Anxiety, depression and quality of life level measured by the Zung self-rating anxiety scale, Zung Self-Rating Depression Scale and The 36-item Short-Form Health Survey.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 46 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Meet intrauterine adhesions diagnostic criteria of ESGE.
- •Patients with clear consciousness, can correct understanding related content of the questionnaire.
排除标准
- •Have a history of mental illness.
- •Receiving psychological treatment currently.
- •Have acute mental disorders.
- •Experienced special stress life events within six months.
结局指标
主要结局
The Zung Self-Rating Anxiety Scale Scores Before and After the Intervention
时间窗: Baseline and 8 weeks
The full name of the scale called Zung Self-Rating Anxiety Scale.The ZSAS contains 20 questions. Each question is scored on a scale of 1-4 (never, some of the time, relatively often, most of the time). Fifteen questions involve the assessment of increasing anxiety levels, and five questions involve decreasing anxiety levels.Each items points accumulated as raw scores,the lowest raw score is 20 points, the highest raw score is 80 points. The raw scores multiply by 1.25, taking the integer part as the standard scores.The ZSAS standard scores were used to define four categories of anxiety severity: within normal rangeor no significant psychopathology (25-49points);presence of mild to moderate anxiety levels (50-59points); severe anxiety levels (60-69points); and presence of extreme depression (70-100points).
次要结局
- Endometrial Thickness Were Measured by Ultrasound in the Middle of Menstruation in All Patients.(3 months)
- Menstruation Was Evaluated With Visual Analogue Scale (VAS) in Which the Menstruation Was Assessed by the Patients Themselves With 0 as Amenorrhea and 100 as Normal Menstruation(3 months)
- Numbers of Participants With Reformation of Intrauterine Adhesions Were Counted by the Follow-up Hysteroscopy Was Performed in the Third Month After the Surgery(3 months)
- The Zung Self-Rating Depression Scale Scores Before and After the Intervention(Baseline and 8 weeks)
- The Scores of Physical Function Before and After the Intervention(One Dimensions of the 36-item Short-form Health Survey)(Baseline and 8 weeks)
- The Scores of Role-physical Before and After the Intervention(One Dimensions of the 36-item Short-form Health Survey)(Baseline and 8 weeks)
- The Scores of Role-emotional Before and After the Intervention(One Dimensions of the 36-item Short-form Health Survey)(Baseline and 8 weeks)
- The Scores of Vitality Before and After the Intervention(One Dimensions of the 36-item Short-form Health Survey)(Baseline and 8 weeks)
- The Scores of Mental Health Before and After the Intervention(One Dimensions of the 36-item Short-form Health Survey)(Baseline and 8 weeks)
- The Scores of Social Functioning Before and After the Intervention(One Dimensions of the 36-item Short-form Health Survey)(Baseline and 8 weeks)
- The Scores of Bodily Pain Before and After the Intervention(One Dimensions of the 36-item Short-form Health Survey)(Baseline and 8 weeks)
- The Scores of General Health Before and After the Intervention(One Dimensions of the 36-item Short-form Health Survey)(Baseline and 8 weeks)
研究者
Yuqing Chen
associate professor
First Affiliated Hospital, Sun Yat-Sen University