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Mindful Living With Stress for Nurses Caring for HIV/AIDS Patients in China (MLWS)

Primary Purpose

Stress

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Mindful Living With Stress
Sponsored by
Central South University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Stress focused on measuring stress, mindfulness, Mindful Living With Stress Intervention, nurse, HIV/AIDS

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

The first step of the study:focus group

Inclusion Criteria:

  1. having a license to practice as a nurse in the People's Republic of China.
  2. being employed as a nurse in the AIDS department of the First Hospital of Changsha for at least 1 year.
  3. Chinese speaking.
  4. being at least 18 years old.

Exclusion Criteria:

  1. being other types of health care providers such as doctors, pharmacists, social workers.
  2. being a nursing supervisor or manager.

The second step of the study: mindfulness intervention

Inclusion Criteria:

  1. having a license to practice as a nurse in the People's Republic of China.
  2. being employed as a nurse in the AIDS department of the First Hospital of Changsha for at least 1 year.
  3. Chinese speaking.
  4. being at least 18 years old.

Exclusion Criteria:

  1. being other types of health care providers such as doctors, pharmacists, social workers.
  2. being a nursing supervisor or manager.
  3. having attended in the focus group of this study.

Sites / Locations

  • The First Hospital of ChangshaRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

mindfulness intervention

Arm Description

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.

Outcomes

Primary Outcome Measures

stress assessed with a self-administrated questionnaire (Chinese Version of Perceived Stress Scale)
At the pre- and post-intervention assessment, participants will complete self-administrated questionnaire on stress.
stress assessed with an in-depth interview
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.

Secondary Outcome Measures

burnout assessed with a self-administrated questionnaire (Chinese Version of Maslach Burnout Inventory)
mindfulness assessed with a self-administrated questionnaire (Chinese Version of Five Facets Mindfulness Questionnaire)
anxiety assessed with a self-administrated questionnaire (State-Trait Anxiety Inventory)
depression assessed with a self-administrated questionnaire (Beck Depression Inventory)

Full Information

First Posted
October 13, 2016
Last Updated
August 27, 2017
Sponsor
Central South University
Collaborators
University of California, Los Angeles
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1. Study Identification

Unique Protocol Identification Number
NCT02936310
Brief Title
Mindful Living With Stress for Nurses Caring for HIV/AIDS Patients in China
Acronym
MLWS
Official Title
Effect of Mindful Living With Stress (MLWS) Intervention for Nurses Caring for HIV/AIDS Patients in China
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Unknown status
Study Start Date
January 2017 (Actual)
Primary Completion Date
September 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Central South University
Collaborators
University of California, Los Angeles

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The primary objective of this proposed one-year (January 01, 2017 to December 31,2017) project is to assess whether a mindfulness based intervention('Mindful Living With Stress') will be effective at helping nurses caring for HIV/AIDS patients in China to reduce stress. Based on the efficacy of previous studies in stress reduction, it is hypothesized that 'Mindful Living With Stress' will be an effective, feasible and affordable stress reduction program in China.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress
Keywords
stress, mindfulness, Mindful Living With Stress Intervention, nurse, HIV/AIDS

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
mindfulness intervention
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Mindful Living With Stress
Intervention Description
The proposed Mindful Living With Stress Intervention will be conducted weekly, 2 hours per session, 4-6 sessions, group based program in mindfulness.
Primary Outcome Measure Information:
Title
stress assessed with a self-administrated questionnaire (Chinese Version of Perceived Stress Scale)
Description
At the pre- and post-intervention assessment, participants will complete self-administrated questionnaire on stress.
Time Frame
nine month
Title
stress assessed with an in-depth interview
Description
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.
Time Frame
nine month
Secondary Outcome Measure Information:
Title
burnout assessed with a self-administrated questionnaire (Chinese Version of Maslach Burnout Inventory)
Time Frame
nine month
Title
mindfulness assessed with a self-administrated questionnaire (Chinese Version of Five Facets Mindfulness Questionnaire)
Time Frame
nine month
Title
anxiety assessed with a self-administrated questionnaire (State-Trait Anxiety Inventory)
Time Frame
nine month
Title
depression assessed with a self-administrated questionnaire (Beck Depression Inventory)
Time Frame
nine month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chen Pan, M.D., Ph.D.
Phone
86-13357319516,424-535-7174
Email
758933968@qq.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chen Pan, M.D., Ph.D.
Organizational Affiliation
Central South University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The First Hospital of Changsha
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410005
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chen Pan, M.D., Ph.D.
Phone
86-13357319516
Email
758933968@qq.com

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
data will be made available within 6 months of study completion

Learn more about this trial

Mindful Living With Stress for Nurses Caring for HIV/AIDS Patients in China

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