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

Not Applicable

Recruiting

• Conditions: Occupational Stress

• Registration Number: NCT06727682
• Lead Sponsor: GCS CIPS

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-11-29
• Study Start: 2024-12-02
• Study First Submitted QC: 2024-12-10
• Study First Posted: 2024-12-11
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-10
• Last Update Posted: 2025-03-11
• Primary Completion: 2025-04
• Study Completion: 2025-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Participation rate	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 Outcome Measures

Name	Time	Method
Job satisfaction	Baseline, 2 months and 3 months	Score on the Overall Job Satisfaction Scale
Acceptance rate	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.
Retention rate	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
Adherence	From the beginning to the end of the study, at 3 months	Average number of visits attended by each participant.
Quality of the intervention	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.
Cost of the programme	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
Heart rate variability	Baseline and 3 months	Recording of resting heart rate variability assessed by RMSSD, SDNN, LF and HF markers.
Occupational stress	Baseline, 2 months and 3 months	Score on the Work Place Stress Scale
Overall stress	Baseline, 2 months and 3 months	Score on the Perceived Stress Scale-10
Risk of burn-out	Baseline, 2 months and 3 months	Score on the Malasch Burnout Inventory
Quality of life	Baseline, 2 months and 3 months	Score on the World Health Organization Quality of Life questionnaire
Self-rated health	Baseline, 2 months and 3 months	Score on the self-rated health scale
Anxiety	Baseline, 2 months and 3 months	Score on the Generalized Anxiety Disorder 7-Item
Perceptions of the quality of patient care	Baseline, 2 months and 3 months	Score on the Victorian Patient Satisfaction Questionnaire
Substance use	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.
Knowledge and mastery of stress management tools	Baseline, 2 months and 3 months	Score on a multiple-choice questionnaire specially designed for the study

Trial Locations

Locations (4)

Korian Parc de l'abbaye; 🇫🇷 Saint-Cyr-l'École, Ile-de-France, France

Korian Parc des dames; 🇫🇷 Saint-Germain-en-Laye, Ile-de-France, France

Korian Le Clos de l'orchidée; 🇫🇷 Narbonne, Occitanie, France

Korian La Colombe; 🇫🇷 Gigean, France