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

Asherman Syndrome Clinical Trial

— 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02746679
• Other study ID #: MBSR-5
• Status: Completed
• Phase: N/A
• First received: April 19, 2016
• Last updated: April 19, 2016
• Start date: January 2015
• Est. completion date: January 2016

Study information

• Verified date: April 2016
• Source: First Affiliated Hospital, Sun Yat-Sen University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Health and Family Planning Commission of Guangdong Province
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 226
• Est. completion date: January 2016
• Est. primary completion date: November 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 46 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Asherman Syndrome

Intervention

Other:
• Mindfulness Based Stress Reduction
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Yuqing Chen

References & Publications (2)

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. — View Citation

Würtzen 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Zung Self-Rating Anxiety Scale scores before and after the intervention		8 weeks	No
Secondary	Endometrial thickness were measured by ultrasound in the middle of menstruation in all patients.		3 months	No
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		3 months	No
Secondary	The numbers of reformation of intrauterine adhesions were counted by the follow-up hysteroscopy was performed in the third month after the surgery		3 months	No
Secondary	The Zung Self-Rating Depression Scale scores before and after the intervention		8weeks	No
Secondary	The scores of physical function before and after the intervention(one dimensions of the 36-item short-form health survey)		8weeks	No
Secondary	The scores of role-physical before and after the intervention(one dimensions of the 36-item short-form health survey)		8weeks	No
Secondary	The scores of role-emotional before and after the intervention(one dimensions of the 36-item short-form health survey)		8weeks	No
Secondary	The scores of vitality before and after the intervention(one dimensions of the 36-item short-form health survey)		8weeks	No
Secondary	The scores of mental health before and after the intervention(one dimensions of the 36-item short-form health survey)		8weeks	No
Secondary	The scores of social functioning before and after the intervention(one dimensions of the 36-item short-form health survey)		8weeks	No
Secondary	The scores of bodily pain before and after the intervention(one dimensions of the 36-item short-form health survey)		8weeks	No
Secondary	The scores of general health before and after the intervention(one dimensions of the 36-item short-form health survey)		8weeks	No