N/A
N=161
Impact of Mindfulness Based Stress Reduction on Anxiety, Depression and QOL in Women With Intrauterine Adhesion.
Asherman Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT02746679 ↗Enrolled (actual)
161
Serious AEs
0.0%
Results posted
Aug 2016
Primary outcome: Primary: The Zung Self-Rating Anxiety Scale Scores Before and After the Intervention — 36.4; 37.3; 32.1; 38.5 units on a scale(raw scores) — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Mindfulness Based Stress Reduction (Other)
- Age
- Adult · 20+ yrs
- Sex
- Female
- Sponsor
- Yuqing Chen
- Primary completion
- Nov 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Zung Self-Rating Anxiety Scale Scores Before and After the Intervention |
36.4; 37.3; 32.1; 38.5 | <0.001 sig |
| SECONDARY Endometrial Thickness Were Measured by Ultrasound in the Middle of Menstruation in All Patients. |
4.4; 4.1; 5.7; 5.2 | >0.05 |
| SECONDARY 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 |
43.9; 44.8; 68.5; 69.2 | >0.05 |
| SECONDARY Numbers of Participants With Reformation of Intrauterine Adhesions Were Counted by the Follow-up Hysteroscopy Was Performed in the Third Month After the Surgery |
14; 26; 62; 49 | 0.024 sig |
| SECONDARY The Zung Self-Rating Depression Scale Scores Before and After the Intervention |
40.3; 39.7; 37.1; 40.9 | <0.001 sig |
| SECONDARY The Scores of Physical Function Before and After the Intervention(One Dimensions of the 36-item Short-form Health Survey) |
86.5; 88.1; 90.9; 85.3 | 0.001 sig |
| SECONDARY The Scores of Role-physical Before and After the Intervention(One Dimensions of the 36-item Short-form Health Survey) |
61.5; 60.3; 74.7; 55.7 | 0.003 sig |
| SECONDARY The Scores of Role-emotional Before and After the Intervention(One Dimensions of the 36-item Short-form Health Survey) |
55.7; 64.0; 78.5; 62.7 | 0.024 sig |
| SECONDARY The Scores of Vitality Before and After the Intervention(One Dimensions of the 36-item Short-form Health Survey) |
67.2; 64.5; 74.9; 62.3 | 0.004 sig |
| SECONDARY The Scores of Mental Health Before and After the Intervention(One Dimensions of the 36-item Short-form Health Survey) |
64.6; 64.9; 72.9; 63.9 | <0.001 sig |
| SECONDARY The Scores of Social Functioning Before and After the Intervention(One Dimensions of the 36-item Short-form Health Survey) |
78.1; 80.3; 86.2; 80.5 | <0.001 sig |
| SECONDARY The Scores of Bodily Pain Before and After the Intervention(One Dimensions of the 36-item Short-form Health Survey) |
71.3; 70.4; 72.5; 68.5 | 0.277 |
| SECONDARY The Scores of General Health Before and After the Intervention(One Dimensions of the 36-item Short-form Health Survey) |
56.9; 58.9; 66.5; 57.1 | 0.001 sig |
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
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.
Data sourced from ClinicalTrials.gov (NCT02746679). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.