Impact of Mindfulness Based Stress Reduction on Anxiety, Depression and Quality of Life in Women With Intrauterine Adhesion:a Randomized Controlled Trial.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Asherman Syndrome
- Sponsor
- Yuqing Chen
- Enrollment
- 226
- Primary Endpoint
- The Zung Self-Rating Anxiety Scale Scores Before and After the Intervention
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
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
Detailed Description
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.
Investigators
Yuqing Chen
associate professor
First Affiliated Hospital, Sun Yat-Sen University
Eligibility Criteria
Inclusion Criteria
- •Meet intrauterine adhesions diagnostic criteria of ESGE.
- •Patients with clear consciousness, can correct understanding related content of the questionnaire.
Exclusion Criteria
- •Have a history of mental illness.
- •Receiving psychological treatment currently.
- •Have acute mental disorders.
- •Experienced special stress life events within six months.
Outcomes
Primary Outcomes
The Zung Self-Rating Anxiety Scale Scores Before and After the Intervention
Time Frame: 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).
Secondary Outcomes
- 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)