- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02936310
Mindful Living With Stress for Nurses Caring for HIV/AIDS Patients in China (MLWS)
Effect of Mindful Living With Stress (MLWS) Intervention for Nurses Caring for HIV/AIDS Patients in China
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Forventet)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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Hunan
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Changsha, Hunan, Kina, 410005
- Rekruttering
- The First Hospital of Changsha
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Ta kontakt med:
- Chen Pan, M.D., Ph.D.
- Telefonnummer: 86-13357319516
- E-post: 758933968@qq.com
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: 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. |
The proposed Mindful Living With Stress Intervention will be conducted weekly, 2 hours per session, 4-6 sessions, group based program in mindfulness.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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stress assessed with a self-administrated questionnaire (Chinese Version of Perceived Stress Scale)
Tidsramme: nine month
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At the pre- and post-intervention assessment, participants will complete self-administrated questionnaire on stress.
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nine month
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stress assessed with an in-depth interview
Tidsramme: nine month
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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.
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nine month
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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burnout assessed with a self-administrated questionnaire (Chinese Version of Maslach Burnout Inventory)
Tidsramme: nine month
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nine month
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mindfulness assessed with a self-administrated questionnaire (Chinese Version of Five Facets Mindfulness Questionnaire)
Tidsramme: nine month
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nine month
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anxiety assessed with a self-administrated questionnaire (State-Trait Anxiety Inventory)
Tidsramme: nine month
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nine month
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depression assessed with a self-administrated questionnaire (Beck Depression Inventory)
Tidsramme: nine month
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nine month
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Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Chen Pan, M.D., Ph.D., Central South University
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- RNA-virusinfeksjoner
- Virussykdommer
- Infeksjoner
- Blodbårne infeksjoner
- Smittsomme sykdommer
- Seksuelt overførbare sykdommer, virale
- Seksuelt overførbare sykdommer
- Lentivirus infeksjoner
- Retroviridae-infeksjoner
- Immunologiske mangelsyndromer
- Sykdommer i immunsystemet
- Langsomme virussykdommer
- HIV-infeksjoner
- Ervervet immunsviktsyndrom
Andre studie-ID-numre
- 16-001305
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
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