Back to resultsImpact of Mindfulness Based Stress Reduction on Anxiety, Depression and QOL in Women With Intrauterine Adhesion. (IMBSRADQWIUA)
Primary Purpose
Asherman Syndrome
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Mindfulness Based Stress Reduction
Sponsored by
About this trial
This is an interventional prevention trial for Asherman Syndrome focused on measuring Asherman syndrome, Mindfulness, Anxiety, Depression, Quality of Life
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
MBSR Group
wait-list control group
Arm Description
The Mindfulness Based Stress Reduction program consisted of eight weekly sessions, each 2.5 hours long, and delivered on consecutive weeks.The Mindfulness Based Stress Reduction therapist participated in the mindfulness exercises with group members during the weekly sessions, and group members were instructed to practice these mindfulness exercises outside group meetings for at least 45 minutes per day, 6 days per week.Group members were taught three main varieties of mindfulness skills: the body scan exercise, sitting meditation, and yoga exercises.The daily homework exercises consisted of repeating body scan work, sitting meditation and yoga exercises at home to provide practice and generalization of the skills.
The patients assigned to the wait-list control group did not receive MBSR intervention for 8 weeks when participants in MBSR were engaged in the MBSR intervention.They only received conventional therapy.
Outcomes
Primary Outcome Measures
The Zung Self-Rating Anxiety Scale Scores Before and After the Intervention
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 Outcome Measures
Endometrial Thickness Were Measured by Ultrasound in the Middle of Menstruation in All Patients.
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
Numbers of Participants With Reformation of Intrauterine Adhesions Were Counted by the Follow-up Hysteroscopy Was Performed in the Third Month After the Surgery
The Zung Self-Rating Depression Scale Scores Before and After the Intervention
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)
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)
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)
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)
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)
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 Social Functioning Before and After the Intervention(One Dimensions of the 36-item Short-form Health Survey)
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 Bodily Pain Before and After the Intervention(One Dimensions of the 36-item Short-form Health Survey)
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 General Health Before and After the Intervention(One Dimensions of the 36-item Short-form Health Survey)
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02746679
Brief Title
Impact of Mindfulness Based Stress Reduction on Anxiety, Depression and QOL in Women With Intrauterine Adhesion.
Acronym
IMBSRADQWIUA
Official Title
Impact of Mindfulness Based Stress Reduction on Anxiety, Depression and Quality of Life in Women With Intrauterine Adhesion:a Randomized Controlled Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
January 2015 (undefined)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
January 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Yuqing Chen
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asherman Syndrome
Keywords
Asherman syndrome, Mindfulness, Anxiety, Depression, Quality of Life
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
226 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MBSR Group
Arm Type
Experimental
Arm Description
The Mindfulness Based Stress Reduction program consisted of eight weekly sessions, each 2.5 hours long, and delivered on consecutive weeks.The Mindfulness Based Stress Reduction therapist participated in the mindfulness exercises with group members during the weekly sessions, and group members were instructed to practice these mindfulness exercises outside group meetings for at least 45 minutes per day, 6 days per week.Group members were taught three main varieties of mindfulness skills: the body scan exercise, sitting meditation, and yoga exercises.The daily homework exercises consisted of repeating body scan work, sitting meditation and yoga exercises at home to provide practice and generalization of the skills.
Arm Title
wait-list control group
Arm Type
No Intervention
Arm Description
The patients assigned to the wait-list control group did not receive MBSR intervention for 8 weeks when participants in MBSR were engaged in the MBSR intervention.They only received conventional therapy.
Intervention Type
Other
Intervention Name(s)
Mindfulness Based Stress Reduction
Intervention Description
Mindfulness Based Stress Reduction programs have been shown to be effective, however, the potential benefits of Mindfulness Based Stress Reduction to decrease depression, anxiety, stress in other diseases. Therefore, the purpose of this study was to examine whether MBSR is effective, and has potential as an intervention to decrease depression, anxiety ,and to improve quality of life of intrauterine adhesion patients.
Primary Outcome Measure Information:
Title
The Zung Self-Rating Anxiety Scale Scores Before and After the Intervention
Description
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).
Time Frame
Baseline and 8 weeks
Secondary Outcome Measure Information:
Title
Endometrial Thickness Were Measured by Ultrasound in the Middle of Menstruation in All Patients.
Time Frame
3 months
Title
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
Title
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
Title
The Zung Self-Rating Depression Scale Scores Before and After the Intervention
Description
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).
Time Frame
Baseline and 8 weeks
Title
The Scores of Physical Function Before and After the Intervention(One Dimensions of the 36-item Short-form Health Survey)
Description
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.
Time Frame
Baseline and 8 weeks
Title
The Scores of Role-physical Before and After the Intervention(One Dimensions of the 36-item Short-form Health Survey)
Description
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.
Time Frame
Baseline and 8 weeks
Title
The Scores of Role-emotional Before and After the Intervention(One Dimensions of the 36-item Short-form Health Survey)
Description
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.
Time Frame
Baseline and 8 weeks
Title
The Scores of Vitality Before and After the Intervention(One Dimensions of the 36-item Short-form Health Survey)
Description
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.
Time Frame
Baseline and 8 weeks
Title
The Scores of Mental Health Before and After the Intervention(One Dimensions of the 36-item Short-form Health Survey)
Description
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.
Time Frame
Baseline and 8 weeks
Title
The Scores of Social Functioning Before and After the Intervention(One Dimensions of the 36-item Short-form Health Survey)
Description
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.
Time Frame
Baseline and 8 weeks
Title
The Scores of Bodily Pain Before and After the Intervention(One Dimensions of the 36-item Short-form Health Survey)
Description
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.
Time Frame
Baseline and 8 weeks
Title
The Scores of General Health Before and After the Intervention(One Dimensions of the 36-item Short-form Health Survey)
Description
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.
Time Frame
Baseline and 8 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
46 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shuzhong Yao, professor
Organizational Affiliation
First Affiliated Hospital, Sun Yat-Sen University
Official's Role
Study Chair
12. IPD Sharing Statement
Plan to Share IPD
Yes
Citations:
PubMed Identifier
14747645
Citation
Roth B, Robbins D. Mindfulness-based stress reduction and health-related quality of life: findings from a bilingual inner-city patient population. Psychosom Med. 2004 Jan-Feb;66(1):113-23. doi: 10.1097/01.psy.0000097337.00754.09.
Results Reference
background
PubMed Identifier
23265707
Citation
Wurtzen H, Dalton SO, Elsass P, Sumbundu AD, Steding-Jensen M, Karlsen RV, Andersen KK, Flyger HL, Pedersen AE, Johansen C. Mindfulness significantly reduces self-reported levels of anxiety and depression: results of a randomised controlled trial among 336 Danish women treated for stage I-III breast cancer. Eur J Cancer. 2013 Apr;49(6):1365-73. doi: 10.1016/j.ejca.2012.10.030. Epub 2012 Dec 19.
Results Reference
background
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Impact of Mindfulness Based Stress Reduction on Anxiety, Depression and QOL in Women With Intrauterine Adhesion.
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