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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01321528
Other study ID # TASMC 11 YL 0037 CTIL
Secondary ID
Status Recruiting
Phase N/A
First received March 10, 2011
Last updated March 24, 2011
Start date March 2011
Est. completion date December 2011

Study information

Verified date March 2011
Source Tel-Aviv Sourasky Medical Center
Contact yaffa lerman, MD
Phone 972-3-6974074
Email yaffale@tasmc.health.gov.il
Is FDA regulated No
Health authority Israel: Ethics Commission
Study type Observational

Clinical Trial Summary

The IBSR (Inquiry-based stress reduction) intervention, developed by Byron Katie (www.thework.com), trains subjects to reduce their perceived level of stress by self-inquiry of their thoughts and beliefs connected to stressful circumstances or symptoms. This meditative process, named "The Work", enables the participants to identify and question the stressful thoughts that cause their suffering. The core of IBSR is simply four questions and a turnaround, which is a way of experiencing the opposite of what the participant believes. This process is simple, powerful and can be easily implemented in daily life.

Therefore, on the basis of previous data and beneficial observations the investigators postulate that the clinical utility of IBSR mediation program may alleviate stress and rate of burnout and improve quality of life among health care professionals. Thus, we will conduct a pilot/feasibility Observational study designed to:

- Assess feasibility of a IBSR intervention by examining attendance, drop-out rates, and program satisfaction.

- investigate whether IBSR intervention is efficacious in alleviating stress and rate of burnout and improving quality of life among health care professionals.


Description:

Study Goals To investigate whether IBSR intervention is efficacious in alleviating stress and rate of burnout and improving quality of life among health care professionals.

Study methodology The proposed study is pilot/feasibility intervention study with pre and post measures. 30 participants will receive Inquiry-based stress reduction (IBSR) group intervention.

Population The pilot intervention group will consist 30 nurses at the Geriatric Rehabilitation Department in the Tel Aviv Sourasky Medical Center (TASMC) who are willing to participate in this study.

Data collection procedures

1. Assessments will be taken at an initial baseline orientation and at the end of the 12-week intervention.

2. One week before IBSR classes will start, a baseline orientation will be held at this session, informed consent will be obtained, baseline data will be collected, and a brief overview of the IBSR program will be provided, which will highlight the 12-week class schedule.

Intervention

1. Subjects will receive weekly 3.5 hour sessions conducted by two facilitators trained in IBSR and certified by BKI to conduct this intervention.

2. Class size will range from 12-16 participants.

3. All the sessions will be standardized and follow the training manual developed to maintain consistency in the program.

4. Subjects will receive a training manual and CD's to support home practice of various forms of inquiry practices.

5. The training manual will include weekly exercises, and program content related to the content identified below. In addition, the manual will include a weekly diary for recording homework practice activities.

The IBSR-BC program is a 12-week program adapted for consideration of health professionals well-being. During the process, participants will be encouraged to identify and inquire about their stressful thoughts: regarding health and illness, relationships with others, Beliefs that prevent them to promote their health, self judgments, perception of death and suffering. This intervention provides for management of specific emotional/psychological symptoms (stress, anxiety, depression) and physical symptoms, such as fatigue and sleeps disorders and enables the participants to inquire and be relieved of their stressful thoughts, and emotions caused by these thoughts. Through the use of self-inquiry practices subjects are taught to increase awareness of their thoughts and feelings, to observe their emotional and physical responses during situations perceived by them as stressful, and allow their mind to return to its true, peaceful, creative nature. Through the process of self inquiry, subjects take an active role in investigating their stressful thoughts, and by this regulating their stress and managing symptoms and emotions, thus enabling them to cope better with with emotional stress and burnout.

Throughout the 12-week IBSR (HCP - health care professionals) program, all subjects will be requested to formally meditate and perform self inquiry exercises alone or with a partner for a minimum of 15 min per day.


Recruitment information / eligibility

Status Recruiting
Enrollment 35
Est. completion date December 2011
Est. primary completion date December 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 67 Years
Eligibility Inclusion Criteria:

1. nurses in the geriatric departments in TASMC

2. Willing to sign an informed consent

3. Age 18-67

Exclusion Criteria:

nursing assistants employees

Study Design

Observational Model: Case-Only, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
Israel Tel-Aviv Sourasky Medical Center Tel-Aviv

Sponsors (1)

Lead Sponsor Collaborator
Tel-Aviv Sourasky Medical Center

Country where clinical trial is conducted

Israel, 

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