Clinical Trial: Impact of Mindfulness Based Stress Reduction on Anxiety, Depression and QOL in Women With Intrauterine Adhesion.

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Impact of Mindfulness Based Stress Reduction on Anxiety, Depression and Quality of Life in Women With Intrauterine Adhesion:a Randomized Controlled Trial.

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 Summary: 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.
Sponsor: Yuqing Chen

Current Primary Outcome: 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).


Original Primary Outcome: The Zung Self-Rating Anxiety Scale Scores Before and After the Intervention [ Time Frame: 8 weeks ]

Current Secondary Outcome:

  • Endometrial Thickness Were Measured by Ultrasound in the Middle of Menstruation in All Patients. [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 3 months ]
  • The Zung Self-Rating Depression Scale Scores Before and After the Intervention [ Time Frame: Baseline and 8 weeks ]
    The full name of the scale called Zung Self-Rating Depression Scale.The ZSDS includes 10 positively worded items and 10 negatively worded items that assess symptoms of depression. Item responses are ranked from 1 to 4, and higher scores correspond to more frequent symptoms. For each item,patients give a score according to whether the item has occurred: 1 = never/very rarely; 2 = once in a while/some of the time/occasionally; 3 = relatively often/very often/often; 4 = most of the time/always. 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 ZSDS standard scores were used to define four categories of depression severity: within normal range or no significant psychopathology (below 51points); presence of minimal to mild depression (51-60points); presence of moderate to marked depression (61-70points).
  • The Scores of Physical Function Before and After the Intervention(One Dimensions of the 36-item Short-form Health Survey) [ Time Frame: Baseline and 8 weeks ]
    The 36-item Short-Form Health Survey (SF-36) is a commonly used generic questionnaire that includes 36 items clustered into eight dimensions (bodily pain, general health, mental health, physical functioning,role-emotional, role-physical, social functioning, and vitality). The item scores for each dimension are coded, summed and transformed to a scale from 0(worst possible health status) to 100 (best possible health status). Each raw scale score is linearly transformed to t scores. The transformed scores range from 0 to 100; higher scores indicate a better health-related QoL.
  • The Scores of Role-physical Before and After the Intervention(One Dimensions of the 36-item Short-form Health Survey) [ Time Frame: Baseline and 8 weeks ]
    The 36-item Short-Form Health Survey (SF-36) is a commonly used generic questionnaire that includes 36 items clustered into eight dimensions (bodily pain, general health, mental health, physical functioning,role-emotional, role-physical, social functioning, and vitality). The item scores for each dimension are coded, summed and transformed to a scale from 0(worst possible health status) to 100 (best possible health status). Each raw scale score is linearly transformed to t scores. The transformed scores range from 0 to 100; higher scores indicate a better health-related QoL.
  • The Scores of Role-emotional Before and After the Intervention(One Dimensions of the 36-item Short-form Health Survey) [ Time Frame: Baseline and 8 weeks ]
    The 36-item Short-Form Health Survey (SF-36) is a commonly used generic questionnaire that includes 36 items clustered into eight dimensions (bodily pain, general health, mental health, physical functioning,role-emotional, role-physical, social functioning, and vitality). The item scores for each dimension are coded, summed and transformed to a scale from 0(worst possible health status) to 100 (best possible health status). Each raw scale score is linearly transformed to t scores. The transformed scores range from 0 to 100; higher scores indicate a better health-related QoL.
  • The Scores of Vitality Before and After the Intervention(One Dimensions of the 36-item Short-form Health Survey) [ Time Frame: Baseline and 8 weeks ]
    The 36-item Short-Form Health Survey (SF-36) is a commonly used generic questionnaire that includes 36 items clustered into eight dimensions (bodily pain, general health, mental health, physical functioning,role-emotional, role-physical, social functioning, and vitality). The item scores for each dimension are coded, summed and transformed to a scale from 0(worst possible health status) to 100 (best possible health status). Each raw scale score is linearly transformed to t scores. The transformed scores range from 0 to 100; higher scores indicate a better health-related QoL.
  • The Scores of Mental Health Before and After the Intervention(One Dimensions of the 36-item Short-form Health Survey) [ Time Frame: Baseline and 8 weeks ]
    The 36-item Short-Form Health Survey (SF-36) is a commonly used generic questionnaire that includes 36 items clustered into eight dimensions (bodily pain, general health, mental health, physical functioning,role-emotional, role-physical, social functioning, and vitality). The item scores for each dimension are coded, summed and transformed to a scale from 0(worst possible health status) to 100 (best possible health status). Each raw scale score is linearly transformed to t scores. The

    Original Secondary Outcome:

    • Endometrial Thickness Were Measured by Ultrasound in the Middle of Menstruation in All Patients. [ Time Frame: 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 [ Time Frame: 3 months ]
    • The numbers of reformation of intrauterine adhesions were counted by the follow-up hysteroscopy was performed in the third month after the surgery [ Time Frame: 3 months ]
    • The Zung Self-Rating Depression Scale Scores Before and After the Intervention [ Time Frame: 8weeks ]
    • The Scores of Physical Function Before and After the Intervention(One Dimensions of the 36-item Short-form Health Survey) [ Time Frame: 8weeks ]
    • The Scores of Role-physical Before and After the Intervention(One Dimensions of the 36-item Short-form Health Survey) [ Time Frame: 8weeks ]
    • The Scores of Role-emotional Before and After the Intervention(One Dimensions of the 36-item Short-form Health Survey) [ Time Frame: 8weeks ]
    • The Scores of Vitality Before and After the Intervention(One Dimensions of the 36-item Short-form Health Survey) [ Time Frame: 8weeks ]
    • The Scores of Mental Health Before and After the Intervention(One Dimensions of the 36-item Short-form Health Survey) [ Time Frame: 8weeks ]
    • The Scores of Social Functioning Before and After the Intervention(One Dimensions of the 36-item Short-form Health Survey) [ Time Frame: 8weeks ]
    • The Scores of Bodily Pain Before and After the Intervention(One Dimensions of the 36-item Short-form Health Survey) [ Time Frame: 8weeks ]
    • The Scores of General Health Before and After the Intervention(One Dimensions of the 36-item Short-form Health Survey) [ Time Frame: 8weeks ]


    Information By: First Affiliated Hospital, Sun Yat-Sen University

    Dates:
    Date Received: April 19, 2016
    Date Started: January 2015
    Date Completion:
    Last Updated: July 16, 2016
    Last Verified: May 2016