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临床试验/NCT06727682
NCT06727682已完成不适用

Feasibility and Relevance of Stress Management Education Delivered Via Virtual Classroom for Carers Working in Specialised Care Units in Nursing Homes: a Pilot Study of a Randomized Controlled Trial

GCS CIPS7 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年12月2日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
GCS CIPS
入组人数
30
试验地点
7
主要终点
Participation rate

研究概览

简要总结

The aim of this cluster-randomised pilot study is to assess the feasibility of a remote stress management programme to reduce occupational stress in healthcare workers in specialised care units of nursing homes. Secondary aims are to assess the effectiveness of the programme in reducing stress in care workers and reducing behavioural and psychological symptoms of dementia in residents.

Participants randomised to the experimental cluster will follow the stress management programme delivered in a virtual classroom. Participants randomised to the control cluster will be placed on a waiting list.

The primary outcome measure will be the participation rate in the study. Other secondary outcomes will include measures of heart rate variability (as a marker of physiological stress) and scores on specific questionnaires for stress, anxiety and risk of burnout in nursing staff in the specialised care units, and behavioural and psychological symptoms of dementia and quality of life in residents in the specialised care units.

Both clusters will complete the same assessments. Participants in the experimental cluster will follow a three-course programme with a psychologist via videoconferencing over a period of 2 months. After the study's final evaluation visit, which will take place one month after the programme, participants in the control cluster will be offered the opportunity to follow the same programme.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Having a caring relationship with residents (e.g. nurses, nursing assistants)
  • Working in the specialised care unit of the nursing home
  • Working in the nursing home for at least 3 months on the date of inclusion and whose employment contract does not end within 3 months of the date of inclusion.
  • Obtaining express written informed consent, after a period of reflection

排除标准

  • Person in a period of relative exclusion in relation to another protocol
  • Person who is not affiliated to or does not benefit from a social security scheme.
  • Pregnant or lactating woman
  • Participant unable to give consent
  • Person deprived of liberty by judicial or administrative decision
  • Person unable to understand, speak, read and write French

结局指标

主要结局

Participation rate

时间窗: From enrollment to the end of the study at 3 months

Participation rate defined as the ratio of the number of participants who completed all study visits to the number of care professionals who agreed to participate.

次要结局

  • Acceptance rate(At enrollment)
  • Retention rate(From enrollment to the end of the study at 3 months)
  • Adherence(From the beginning to the end of the study, at 3 months)
  • Quality of the intervention(At the end of the intervention, at 3 months)
  • Cost of the programme(From enrollment to the end of the study at 3 months)
  • Heart rate variability(Baseline and 3 months)
  • Occupational stress(Baseline, 2 months and 3 months)
  • Overall stress(Baseline, 2 months and 3 months)
  • Job satisfaction(Baseline, 2 months and 3 months)
  • Risk of burn-out(Baseline, 2 months and 3 months)
  • Quality of life(Baseline, 2 months and 3 months)
  • Self-rated health(Baseline, 2 months and 3 months)
  • Anxiety(Baseline, 2 months and 3 months)
  • Perceptions of the quality of patient care(Baseline, 2 months and 3 months)
  • Substance use(Baseline, 2 months and 3 months)
  • Knowledge and mastery of stress management tools(Baseline, 2 months and 3 months)

研究者

发起方
GCS CIPS
申办方类型
Other
责任方
Sponsor

研究点 (7)

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