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

Stress Clinical Trial

— MLWS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02936310
• Other study ID #: 16-001305
• Status: Recruiting
• Phase: N/A
• First received: October 13, 2016
• Last updated: August 27, 2017
• Start date: January 2017
• Est. completion date: December 2017

Study information

• Verified date: August 2017
• Source: Central South University
• Contact: Chen Pan, M.D., Ph.D.
• Phone: 86-13357319516,424-535-7174
• Email: 758933968[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 18
• Est. completion date: December 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Stress

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.

Locations

Country	Name	City	State
China	The First Hospital of Changsha	Changsha	Hunan

Sponsors (2)

Lead Sponsor	Collaborator
Central South University	University of California, Los Angeles

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	nine month
Primary	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.	nine month
Secondary	burnout assessed with a self-administrated questionnaire (Chinese Version of Maslach Burnout Inventory)		nine month
Secondary	mindfulness assessed with a self-administrated questionnaire (Chinese Version of Five Facets Mindfulness Questionnaire)		nine month
Secondary	anxiety assessed with a self-administrated questionnaire (State-Trait Anxiety Inventory)		nine month
Secondary	depression assessed with a self-administrated questionnaire (Beck Depression Inventory)		nine month