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

August 27, 2017 updated by: Chen Pan, Central South University

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Anticipated)

18

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Hunan
      • Changsha, Hunan, China, 410005
        • Recruiting
        • The First Hospital of Changsha
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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.
Behavioral: Mindful Living With Stress
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.
nine month
stress assessed with an in-depth interview
Time Frame: nine month
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.
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

This is where you will find people and organizations involved with this study.

Sponsor

Central South University

Collaborators

University of California, Los Angeles

Investigators

  • Principal Investigator: Chen Pan, M.D., Ph.D., Central South University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2017

Primary Completion (Anticipated)

September 1, 2017

Study Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

October 13, 2016

First Submitted That Met QC Criteria

October 14, 2016

First Posted (Estimate)

October 18, 2016

Study Record Updates

Last Update Posted (Actual)

August 29, 2017

Last Update Submitted That Met QC Criteria

August 27, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16-001305

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

data will be made available within 6 months of study completion

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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