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

NCT02746679 | Completed Results DMC

• 1 other identifier: MBSR-5
• Study Type: interventional
• Target: 226
• Locations: 0 countries
• Sites: N/A

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

Conditions

Asherman Syndrome

Keywords

Asherman syndrome; Mindfulness; Anxiety; Depression; Quality of Life

Outcome Measures

Primary Outcomes (1)

• The Zung Self-Rating Anxiety Scale Scores Before and After the Intervention

  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 Outcomes (12)

• 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 Scores of Physical Function Before and After the Intervention(One Dimensions of the 36-item Short-form Health Survey)

  Baseline and 8 weeks

Study Arms (2)

MBSR Group

EXPERIMENTAL

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.

Other: Mindfulness Based Stress Reduction

wait-list control group

NO INTERVENTION

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.

Interventions

Mindfulness Based Stress Reduction OTHER

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.

MBSR Group

Eligibility Criteria

• Age: 20 Years - 46 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Yuqing Chen: lead

Related 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. doi: 10.1097/01.psy.0000097337.00754.09.

  PMID: 14747645 BACKGROUND

• 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.

  PMID: 23265707 BACKGROUND

MeSH Terms

Conditions

Gynatresia; Anxiety Disorders; Depression

Interventions

Mindfulness-Based Stress Reduction

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Mindfulness; Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Results Point of Contact

• Title: Yuqing Chen
• Organization: The First Affiliated Hospital of Sun Yat-sen University

fangchenyq@163.com

+86 020-87755766-8341

Study Officials

• Shuzhong Yao, professor

  First Affiliated Hospital, Sun Yat-Sen University

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: associate professor

Study Record Dates

• First Submitted: April 19, 2016
• First Posted: April 21, 2016
• Study Start: January 1, 2015
• Primary Completion: November 1, 2015
• Study Completion: January 1, 2016
• Last Updated: August 26, 2016
• Results First Posted: August 26, 2016

Record last verified: 2016-05

Data Sharing

• IPD Sharing: Will share