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Completed

NCT Number: NCT06727682

Feasibility of Stress Management Education Delivered Via Virtual Classroom in Nursing Homes: a Pilot Study of a RCT

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.

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Key information

Conditions

Occupational Stress Behavior Behavioral Symptoms Occupational Diseases Stress, Psychological

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Korian La Colombe, Gigean, France

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Stress Management

Behavioral

Ten-hour, three-course stress management programme with a psychologist via video conferencing over a 2 month period. The classes will be delivered in small groups of maximum seven care workers. Carers can be brought together in the same room, but the speaker will necessarily be at a distance, via videoconferencing. The formation will adress the following issues: i) Understanding the mechanisms of stress, ii) Identifying sources of stress and triggers, iii) Anticipate stressful situations and use their resources to prevent them, and iv) Use the most appropriate stress-reduction techniques, depending on their sensitivity.

Primary outcomes

  1. Participation rate

    Time frame: 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.

Secondary outcomes

  1. Acceptance rate

    Time frame: At enrollment

    Ratio between the total number of eligible healthcare workers and the number of healthcare worker who accept to be enrolled in the study.

  2. Retention rate

    Time frame: From enrollment to the end of the study at 3 months

    Ratio between the number of care professionals still present at the last visit of the study and the number of care professionals included in the study

  3. Adherence

    Time frame: From the beginning to the end of the study, at 3 months

    Average number of visits attended by each participant.

  4. Quality of the intervention

    Time frame: At the end of the intervention, at 3 months

    Feedback on the relevance of the training and its contribution through semi-directive interviews and focus groups in participants and in managers and directors of the nursing homes.

  5. Cost of the programme

    Time frame: From enrollment to the end of the study at 3 months

    Total cost of the stress management program including the costs incurred to enable the employee to follow the training and/or the costs incurred to replace the absence of the employee in the service

  6. Heart rate variability

    Time frame: Baseline and 3 months

    Recording of resting heart rate variability assessed by RMSSD, SDNN, LF and HF markers.

  7. Occupational stress

    Time frame: Baseline, 2 months and 3 months

    Score on the Work Place Stress Scale

  8. Overall stress

    Time frame: Baseline, 2 months and 3 months

    Score on the Perceived Stress Scale-10

  9. Job satisfaction

    Time frame: Baseline, 2 months and 3 months

    Score on the Overall Job Satisfaction Scale

  10. Risk of burn-out

    Time frame: Baseline, 2 months and 3 months

    Score on the Malasch Burnout Inventory

  11. Quality of life

    Time frame: Baseline, 2 months and 3 months

    Score on the World Health Organization Quality of Life questionnaire

  12. Self-rated health

    Time frame: Baseline, 2 months and 3 months

    Score on the self-rated health scale

  13. Anxiety

    Time frame: Baseline, 2 months and 3 months

    Score on the Generalized Anxiety Disorder 7-Item

  14. Perceptions of the quality of patient care

    Time frame: Baseline, 2 months and 3 months

    Score on the Victorian Patient Satisfaction Questionnaire

  15. Substance use

    Time frame: Baseline, 2 months and 3 months

    Usual substance use (tobacco, alcohol, drugs...), assessed by a questionnaire that records the type of substance and frequency of use.

  16. Knowledge and mastery of stress management tools

    Time frame: Baseline, 2 months and 3 months

    Score on a multiple-choice questionnaire specially designed for the study

Other outcomes

  1. Residents' level of agitation in the specialised care units

    Time frame: Baseline and 3 months

    Perceived residents' level of agitation by the healtcare workers assessed by the score on the Cohen-Mansfield Agitation Inventory

  2. Health-related quality of life of residents in the specialised care units

    Time frame: Baseline and 3 months

    Residents' health-related quality of life as perceived by healthcare workers, as assessed by scores on the 'Quality of Life in Late Stage Dementia' questionnaire.

  3. Behavioural and psychological symptoms of dementia in the residents of the specialised care units

    Time frame: Baseline and 3 months

    Residents' behavioural and psychological symptoms of dementia as perceived by healthcare workers, as assessed by the "Neuropsychiatric inventory" questionnaire

Sponsors and collaborators

Lead sponsor

GCS CIPS

Other

Registry information

Official study title

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

Acronym: AGIT-RESTS-1

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 11, 2024
Registry last updated
Aug 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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