- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02746679
Impact of Mindfulness Based Stress Reduction on Anxiety, Depression and QOL in Women With Intrauterine Adhesion. (IMBSRADQWIUA)
July 16, 2016 updated by: Yuqing Chen
Impact of Mindfulness Based Stress Reduction on Anxiety, Depression and Quality of Life in Women With Intrauterine Adhesion:a Randomized Controlled Trial.
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
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
226
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 46 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: MBSR Group
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.
|
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.
|
No Intervention: wait-list control group
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
Baseline and 8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Endometrial Thickness Were Measured by Ultrasound in the Middle of Menstruation in All Patients.
Time Frame: 3 months
|
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
|
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
|
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).
|
Baseline and 8 weeks
|
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.
|
Baseline and 8 weeks
|
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.
|
Baseline and 8 weeks
|
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.
|
Baseline and 8 weeks
|
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.
|
Baseline and 8 weeks
|
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 transformed scores range from 0 to 100; higher scores indicate a better health-related QoL.
|
Baseline and 8 weeks
|
The Scores of Social Functioning 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.
|
Baseline and 8 weeks
|
The Scores of Bodily Pain 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.
|
Baseline and 8 weeks
|
The Scores of General 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 transformed scores range from 0 to 100; higher scores indicate a better health-related QoL.
|
Baseline and 8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Shuzhong Yao, professor, First Affiliated Hospital, Sun Yat-Sen University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2015
Primary Completion (Actual)
November 1, 2015
Study Completion (Actual)
January 1, 2016
Study Registration Dates
First Submitted
April 19, 2016
First Submitted That Met QC Criteria
April 19, 2016
First Posted (Estimate)
April 21, 2016
Study Record Updates
Last Update Posted (Estimate)
August 26, 2016
Last Update Submitted That Met QC Criteria
July 16, 2016
Last Verified
May 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MBSR-5
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Yes
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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