- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02936310
Mindful Living With Stress for Nurses Caring for HIV/AIDS Patients in China (MLWS)
Effect of Mindful Living With Stress (MLWS) Intervention for Nurses Caring for HIV/AIDS Patients in China
Study Overview
Detailed Description
Background: Considering the great stress in the nurses caring for HIV/AIDS patients, the situation of more serious nursing shortage in China, and the acceptability, feasibility and efficacy of mindfulness-based interventions for reducing stress in health care professionals, here investigators propose a study of "Effect of Mindful Living With Stress (MLWS) Intervention for nurses caring for HIV/AIDS patients in China".
Objectives: The primary objective of this proposed project is to assess whether a program of mindfulness-based stress reduction interventions developed based on Mindfulness Based Stress Reduction (MBSR), Mindful Awareness Practices(MAPs)and chinese culture will be effective at helping nurses caring for HIV/AIDS patients in China to reduce stress and burnout. Based on the efficacy of previous studies in reducing stress, investigators hypothesize that 'Mindful Living With Stress' will be an effective, feasible and affordable stress reduction program for nurses caring for HIV/AIDS patients in China.
Methods: Nurses working in the AIDS department of the First Hospital of Changsha, China will be recruited for the study. The two steps to be implemented include: 1) conducting focus groups with nurses for the purpose of finalizing the design of the MLWS Intervention: A convenience sample of 10 nurses will be recruited and the final sample is expected to include 6-8 participants who will attend two consecutive focus group sessions. The first focus group session will explore the experiences of nurses caring for HIV/AIDS patients and the second focus group session will discuss the design of the MLWS Intervention. The qualitative data will be analyzed after the focus group discussions and the findings will provide important information for development of the final manual for guiding the intervention, and 2) evaluating the effects of the MLWS Intervention in a group of nurses: A convenience sample of 23 nurses will be recruited and the final sample is expected to include 16-18 nurses. The quantitative data from 5 measures assessing stress, burnout, mindfulness, anxiety and depression will be collected and analyzed at pre- and post- intervention. The qualitative data from an in-depth interview will be collected and analyzed at post-intervention.
Implications: The results will provide valuable insights into the effect of MLWS Intervention on stress of nurses caring for HIV/AIDS patients in China. If the MLWS Intervention can be used effectively, it can also be popularized to many other health care professionals caring for HIV/AIDS in China in future.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Chen Pan, M.D., Ph.D.
- Phone Number: 86-13357319516,424-535-7174
- Email: 758933968@qq.com
Study Locations
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Hunan
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Changsha, Hunan, China, 410005
- Recruiting
- The First Hospital of ChangSha
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Contact:
- Chen Pan, M.D., Ph.D.
- Phone Number: 86-13357319516
- Email: 758933968@qq.com
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
The first step of the study:focus group
Inclusion Criteria:
- having a license to practice as a nurse in the People's Republic of China.
- being employed as a nurse in the AIDS department of the First Hospital of Changsha for at least 1 year.
- Chinese speaking.
- being at least 18 years old.
Exclusion Criteria:
- being other types of health care providers such as doctors, pharmacists, social workers.
- being a nursing supervisor or manager.
The second step of the study: mindfulness intervention
Inclusion Criteria:
- having a license to practice as a nurse in the People's Republic of China.
- being employed as a nurse in the AIDS department of the First Hospital of Changsha for at least 1 year.
- Chinese speaking.
- being at least 18 years old.
Exclusion Criteria:
- being other types of health care providers such as doctors, pharmacists, social workers.
- being a nursing supervisor or manager.
- having attended in the focus group of this study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: mindfulness intervention
The proposed Mindful Living With Stress Intervention will be conducted weekly, 2 hours per session, 4-6 sessions, group based program in mindfulness.The proposed topics include: 1) mindfulness: dealing with stress in a new way, 2) mindful awareness of stress: listening to our body, 3) mindful working with thoughts, 4) mindful working with emotions, 5) mindful interactions, and 6) dealing with obstacles of mindful practices and wrap-up. Mindfulness practices embedded in the program will include mindfulness breathing meditation, sitting meditation, standing meditation, walking meditation, movement meditation (Taichi or Yoga), body scan meditation and daily life meditation. Data will be collected at pre-intervention (one week before the first session) and post-intervention (one week after the last session) to assess stress, burnout, mindfulness, anxiety,depression,the feedback on the MLWS intervention and the feedback on the influence of MLWS intervention. |
The proposed Mindful Living With Stress Intervention will be conducted weekly, 2 hours per session, 4-6 sessions, group based program in mindfulness.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
stress assessed with a self-administrated questionnaire (Chinese Version of Perceived Stress Scale)
Time Frame: nine month
|
At the pre- and post-intervention assessment, participants will complete self-administrated questionnaire on stress.
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nine month
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stress assessed with an in-depth interview
Time Frame: nine month
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At the post-intervention assessment,participants will be invited to attend an in-depth interview to give the feedback on the influence of MLWS intervention on living with stress.
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nine month
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
burnout assessed with a self-administrated questionnaire (Chinese Version of Maslach Burnout Inventory)
Time Frame: nine month
|
nine month
|
mindfulness assessed with a self-administrated questionnaire (Chinese Version of Five Facets Mindfulness Questionnaire)
Time Frame: nine month
|
nine month
|
anxiety assessed with a self-administrated questionnaire (State-Trait Anxiety Inventory)
Time Frame: nine month
|
nine month
|
depression assessed with a self-administrated questionnaire (Beck Depression Inventory)
Time Frame: nine month
|
nine month
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Chen Pan, M.D., Ph.D., Central South University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Immune System Diseases
- Slow Virus Diseases
- HIV Infections
- Acquired Immunodeficiency Syndrome
Other Study ID Numbers
- 16-001305
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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