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

Not Applicable

Completed

• Conditions: Asherman Syndrome
• Interventions: Other: Mindfulness Based Stress Reduction

• Registration Number: NCT02746679
• Lead Sponsor: Yuqing Chen

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.

Study Timeline

• Study Start: 2015-01
• Primary Completion: 2015-11
• Study Completion: 2016-01
• Study First Submitted: 2016-04-19
• Study First Submitted QC: 2016-04-19
• Study First Posted: 2016-04-21
• Status Verified: 2016-05
• Results First Submitted: 2016-05-25
• Results First Submitted QC: 2016-07-16
• Last Update Submitted: 2016-07-16
• Results First Posted: 2016-08-26
• Last Update Posted: 2016-08-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 226

Inclusion Criteria

1. Meet intrauterine adhesions diagnostic criteria of ESGE.
2. Patients with clear consciousness, can correct understanding related content of the questionnaire.

Exclusion Criteria

1. Have a history of mental illness.
2. Receiving psychological treatment currently.
3. Have acute mental disorders.
4. Experienced special stress life events within six months.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MBSR Group	Mindfulness Based Stress Reduction	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.

Primary Outcome Measures

Name	Time	Method
The Zung Self-Rating Anxiety Scale Scores Before and After the Intervention	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 Outcome Measures

Name	Time	Method
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 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)	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)	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)	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)	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)	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 Social Functioning Before and After the Intervention(One Dimensions of the 36-item Short-form Health Survey)	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 Bodily Pain Before and After the Intervention(One Dimensions of the 36-item Short-form Health Survey)	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 General Health Before and After the Intervention(One Dimensions of the 36-item Short-form Health Survey)	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.