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

NCT ID: NCT02746679

Last Updated: 2016-08-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 226 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2016-01-31

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.

Conditions

Asherman Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

MBSR Group

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.

Group Type: EXPERIMENTAL

Mindfulness Based Stress Reduction

Intervention Type: 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.

wait-list control group

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 46 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Yuqing Chen

OTHER

Sponsor Role: lead

Responsible Party

Yuqing Chen

associate professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Shuzhong Yao, professor

Role: STUDY_CHAIR

First Affiliated Hospital, Sun Yat-Sen University

References

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.

Reference Type: BACKGROUND

PMID: 14747645 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23265707 (View on PubMed)

Other Identifiers

MBSR-5

Identifier Type: -

Identifier Source: org_study_id