Clinical trial NCT02936310: Mindful Living With Stress for Nurses Caring for HIV/AIDS Patients in China
Official title: Effect of Mindful Living With Stress (MLWS) Intervention for Nurses Caring for HIV/AIDS Patients in China
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stress
Keywords: stress
mindfulness
Mindful Living With Stress Intervention
nurse
HIV/AIDS
Lead sponsor: Central South University
Sponsor class: OTHER
Collaborators: name: University of California, Los Angeles
First posted: 2016-10-18
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: stress assessed with a self-administrated questionnaire （Chinese Version of Perceived Stress Scale）
timeFrame: nine month
measure: stress assessed with an in-depth interview
timeFrame: nine month
Secondary outcomes:
measure: burnout assessed with a self-administrated questionnaire (Chinese Version of Maslach Burnout Inventory)
timeFrame: nine month
measure: mindfulness assessed with a self-administrated questionnaire (Chinese Version of Five Facets Mindfulness Questionnaire)
timeFrame: nine month
measure: anxiety assessed with a self-administrated questionnaire （State-Trait Anxiety Inventory）
timeFrame: nine month
measure: depression assessed with a self-administrated questionnaire （Beck Depression Inventory）
timeFrame: nine month
Other outcomes:
Locations:
city: Changsha
country: China
facility: The First Hospital of Changsha
state: Hunan
Study officials:
affiliation: Central South University
name: Chen Pan, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: