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

NCT ID: NCT06727682

Last Updated: 2025-08-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-02
• Study Completion Date: 2025-05-22

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.

Conditions

Occupational Stress

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Remote stress management programme

Ten-hour, three-course stress management programme with a psychologist via video conferencing over 2 months

Group Type: EXPERIMENTAL

Stress management

Intervention Type: 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.

Waiting list

No intervention during the study duration. However, after the end of the study, after the last evaluations, participants in this control cluster will be offered the opportunity to follow the stress management programme.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Stress management

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

GCS CIPS

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Fariba Kabirian, MD

Role: PRINCIPAL_INVESTIGATOR

France Chief Medical Officer, Clariane

Locations

Korian La Colombe

Gigean, France, France

Korian Le Clos de l'orchidée

Narbonne, Occitanie, France

Korian Parc de l'abbaye

Saint-Cyr-l'École, Île-de-France Region, France

Korian Parc des dames

Saint-Germain-en-Laye, Île-de-France Region, France

Countries

France

Other Identifiers

AGIT-RESTS-1

Identifier Type: -

Identifier Source: org_study_id