A randomised study to evaluate the potential added value of shared meditation involving people with cancer, health professionals and third persons compared to meditation conducted with patients only: design of the Implic-2 protocol.
Cancer patients
Health professionals
Mindfulness
Randomised trial
Well-being
Journal
BMC cancer
ISSN: 1471-2407
Titre abrégé: BMC Cancer
Pays: England
ID NLM: 100967800
Informations de publication
Date de publication:
04 Sep 2024
04 Sep 2024
Historique:
received:
07
02
2024
accepted:
14
06
2024
medline:
5
9
2024
pubmed:
5
9
2024
entrez:
4
9
2024
Statut:
epublish
Résumé
In oncology, the suffering of patients and the burnout of health professionals are key issues. Mindfulness meditation is a holistic approach that can help to improve well-being. While numerous studies have shown the benefits of meditation for both patients and health professionals, the added value of offering shared meditation to groups of patients, health professionals and third persons has not been assessed. Beyond strengthening the relationship between carers and patients, opening up meditation sessions to third parties (neither carers nor patients) enables patients to escape the stigma of their illness. We previously conducted a pilot study that validated the feasibility and the relevance of shared meditation with a specifically designed programme. IMPLIC-2 is a two-arm randomised study designed to assess the added value of this meditation programme (optimised following the pilot study), particularly for cancer patients (our target population). People motivated to follow the programme, without previous regular practice of meditation and able to participate in the sessions are eligible. The study will include 96 participants: 16 health professionals, 16 third persons and 64 patients. The latter will be randomized in two arms: the experimental arm ("Shared" meditation) consisting of 4 mixed groups of 8 patients, 4 health professionals and 4 third parties, and the control arm ("Patient" meditation) consisting of 2 groups of 16 patients. Validated questionnaires will be used to measure the effects of the programme, notably in terms of quality of life, perceived stress, feelings of self-efficacy, qualities of mindfulness and self-compassion, and carers' burn-out. Participants' perception of a change in their quality of life and satisfaction will be measured at the end of the programme. A complementary qualitative focus-group approach will be used to optimise implementation of the programme beyond the study. The well-being of oncology patients would be improved. Dealing with overworked carers would have a beneficial impact on the way they interact with patients. In addition, encounters between the three types of population will allow otherness to be viewed differently and alleviate suffering by promoting collective humanity. NCT06041607, registered: 09/18/2023. Version n°1.2 dated from 08/29/2023.
Sections du résumé
BACKGROUND
BACKGROUND
In oncology, the suffering of patients and the burnout of health professionals are key issues. Mindfulness meditation is a holistic approach that can help to improve well-being. While numerous studies have shown the benefits of meditation for both patients and health professionals, the added value of offering shared meditation to groups of patients, health professionals and third persons has not been assessed. Beyond strengthening the relationship between carers and patients, opening up meditation sessions to third parties (neither carers nor patients) enables patients to escape the stigma of their illness. We previously conducted a pilot study that validated the feasibility and the relevance of shared meditation with a specifically designed programme.
METHODS/DESIGN
METHODS
IMPLIC-2 is a two-arm randomised study designed to assess the added value of this meditation programme (optimised following the pilot study), particularly for cancer patients (our target population). People motivated to follow the programme, without previous regular practice of meditation and able to participate in the sessions are eligible. The study will include 96 participants: 16 health professionals, 16 third persons and 64 patients. The latter will be randomized in two arms: the experimental arm ("Shared" meditation) consisting of 4 mixed groups of 8 patients, 4 health professionals and 4 third parties, and the control arm ("Patient" meditation) consisting of 2 groups of 16 patients. Validated questionnaires will be used to measure the effects of the programme, notably in terms of quality of life, perceived stress, feelings of self-efficacy, qualities of mindfulness and self-compassion, and carers' burn-out. Participants' perception of a change in their quality of life and satisfaction will be measured at the end of the programme. A complementary qualitative focus-group approach will be used to optimise implementation of the programme beyond the study.
DISCUSSION
CONCLUSIONS
The well-being of oncology patients would be improved. Dealing with overworked carers would have a beneficial impact on the way they interact with patients. In addition, encounters between the three types of population will allow otherness to be viewed differently and alleviate suffering by promoting collective humanity.
TRIAL REGISTRATION
BACKGROUND
NCT06041607, registered: 09/18/2023.
PROTOCOL VERSION
METHODS
Version n°1.2 dated from 08/29/2023.
Identifiants
pubmed: 39232668
doi: 10.1186/s12885-024-12521-1
pii: 10.1186/s12885-024-12521-1
doi:
Banques de données
ClinicalTrials.gov
['NCT06041607']
Types de publication
Journal Article
Randomized Controlled Trial
Clinical Trial Protocol
Langues
eng
Sous-ensembles de citation
IM
Pagination
1097Informations de copyright
© 2024. The Author(s).
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