StressMLWSNCT02936310
Mindful Living With Stress for Nurses Caring for HIV/AIDS Patients in China
A study testing Mindful Living With Stress in people with Stress, run by Central South University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stress
- What is being tested?
- Mindful Living With Stress
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteChina
- Study dates
- Jan 2017to Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- 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.
Who cannot join
- 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
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Hospital of Changsha
Changsha, Hunan, 410005
Chen Pan, M.D., Ph.D., 86-13357319516, 758933968@qq.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Stress
- Being tested
- Mindful Living With Stress
- Keywords
- stress, mindfulness, Mindful Living With Stress Intervention, nurse, HIV/AIDS
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindful Living With StressBehavioural
The proposed Mindful Living With Stress Intervention will be conducted weekly, 2 hours per session, 4-6 sessions, group based program in mindfulness.
| Study group | Role | What they receive |
|---|---|---|
| mindfulness intervention | Experimental | 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. Receives: Behavioral: Mindful Living With Stress |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: nine month
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.
Measured: nine month
Secondary outcomes (4)
burnout assessed with a self-administrated questionnaire (Chinese Version of Maslach Burnout Inventory)
Measured: nine month
mindfulness assessed with a self-administrated questionnaire (Chinese Version of Five Facets Mindfulness Questionnaire)
Measured: nine month
anxiety assessed with a self-administrated questionnaire （State-Trait Anxiety Inventory）
Measured: nine month
depression assessed with a self-administrated questionnaire （Beck Depression Inventory）
Measured: nine month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2016 (estimated)
- Study startJan 2017
- Primary completionSep 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central South University
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, Los Angeles
- Responsible party
- Principal investigator, Chen Pan, Central South University
- Investigators
- Chen Pan, M.D., Ph.D., Principal investigator, Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02936310
- Sponsor's protocol ID
- 16-001305
- Acronym
- MLWS
- Status last verified
- Aug 2017
- First submitted
- 13 Oct 2016
- Last updated
- 29 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: data will be made available within 6 months of study completion
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Mindful Living With Stress (MLWS) Intervention for Nurses Caring for HIV/AIDS Patients in China
- ClinicalTrials.gov ID
- NCT02936310
- Acronym / sponsor ID
- MLWS / 16-001305
- Conditions
- Stress
- Keywords
- stress, mindfulness, Mindful Living With Stress Intervention, nurse, HIV/AIDS
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Central South UniversityUniversity, hospital or other
- Collaborators
- University of California, Los Angeles
- Study start
- Jan 2017 (actual)
- Primary completion
- Sep 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 18 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| mindfulness intervention | Experimental | Behavioral: Mindful Living With StressThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
- having a license to practice as a nurse in the People's Republic of China.
Key exclusion criteria (6 listed)
- 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
- being other types of health care providers such as doctors, pharmacists, social workers.
- being a nursing supervisor or manager.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindful Living With StressThe proposed Mindful Living With Stress Intervention will be conducted weekly, 2 hours per session, 4-6 sessions, group based program in mindfulness. | Behavioural | mindfulness intervention |
Primary outcome
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.
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.
4 secondary outcomes
burnout assessed with a self-administrated questionnaire (Chinese Version of Maslach Burnout Inventory)
Time frame: nine month
mindfulness assessed with a self-administrated questionnaire (Chinese Version of Five Facets Mindfulness Questionnaire)
Time frame: nine month
anxiety assessed with a self-administrated questionnaire （State-Trait Anxiety Inventory）
Time frame: nine month
depression assessed with a self-administrated questionnaire （Beck Depression Inventory）
Time frame: nine month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2017.
- Individual participant dataSharing planned: Yes. data will be made available within 6 months of study completion
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chen Pan, M.D., Ph.D. principal investigator
Central South University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindful Living With Stress in people with Stress, run by Central South University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chen Pan, M.D., Ph.D. (86-13357319516,424-535-7174, 758933968@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
stress assessed with a self-administrated questionnaire （Chinese Version of Perceived Stress Scale） (time frame: nine month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2017.