Clinical trial NCT02746679: Impact of Mindfulness Based Stress Reduction on Anxiety, Depression and QOL in Women With Intrauterine Adhesion.
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
Overall status: COMPLETED
Phase: NA
Conditions: Asherman Syndrome
Keywords: Asherman syndrome
Mindfulness
Anxiety
Depression
Quality of Life
Lead sponsor: First Affiliated Hospital, Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2016-04-21
Enrollment: 226
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 46
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The Zung Self-Rating Anxiety Scale Scores Before and After the Intervention
timeFrame: Baseline and 8 weeks
Secondary outcomes:
measure: Endometrial Thickness Were Measured by Ultrasound in the Middle of Menstruation in All Patients.
timeFrame: 3 months
measure: 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
timeFrame: 3 months
measure: Numbers of Participants With Reformation of Intrauterine Adhesions Were Counted by the Follow-up Hysteroscopy Was Performed in the Third Month After the Surgery
timeFrame: 3 months
measure: The Zung Self-Rating Depression Scale Scores Before and After the Intervention
timeFrame: Baseline and 8 weeks
measure: The Scores of Physical Function Before and After the Intervention(One Dimensions of the 36-item Short-form Health Survey)
timeFrame: Baseline and 8 weeks
measure: The Scores of Role-physical Before and After the Intervention(One Dimensions of the 36-item Short-form Health Survey)
timeFrame: Baseline and 8 weeks
measure: The Scores of Role-emotional Before and After the Intervention(One Dimensions of the 36-item Short-form Health Survey)
timeFrame: Baseline and 8 weeks
measure: The Scores of Vitality Before and After the Intervention(One Dimensions of the 36-item Short-form Health Survey)
timeFrame: Baseline and 8 weeks
measure: The Scores of Mental Health Before and After the Intervention(One Dimensions of the 36-item Short-form Health Survey)
timeFrame: Baseline and 8 weeks
measure: The Scores of Social Functioning Before and After the Intervention(One Dimensions of the 36-item Short-form Health Survey)
timeFrame: Baseline and 8 weeks
measure: The Scores of Bodily Pain Before and After the Intervention(One Dimensions of the 36-item Short-form Health Survey)
timeFrame: Baseline and 8 weeks
measure: The Scores of General Health Before and After the Intervention(One Dimensions of the 36-item Short-form Health Survey)
timeFrame: Baseline and 8 weeks
Other outcomes:
Locations:
Study officials:
affiliation: First Affiliated Hospital, Sun Yat-Sen University
name: Shuzhong Yao, professor
role: STUDY_CHAIR
References:
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.
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.