Dyspnoea is an existentially burdensome symptom in patients with advanced and progressive diseases such as cancer, chronic obstructive pulmonary disease (COPD) and advanced heart failure. Recent studies have highlighted that symptomatic treatment of dyspnoea is often ineffective and may depend on the underlying disease. Immersive virtual reality (IVR) has emerged as a ‘digital therapeutic’ for conditions such as pain, anxiety, and dyspnoea. Brain functional MRI (fMRI) offers the opportunity to identify distinct patterns of dyspnoea. Current findings are mainly limited to healthy volunteers, but clinical data from patients with life-limiting conditions are needed. The aim of this study is to assess the feasibility of identifying dyspnoea patterns in different life-limiting conditions using fMRI and IVR.
This is an observational monocentric feasibility study, conducted in a tertiary university centre. Healthy volunteers and patients diagnosed with advanced cancer, COPD, or heart failure and suffering from persistent dyspnoea will undergo an fMRI of the brain using IVR. The primary outcome of feasibility will be evaluated using descriptive statistics. Secondary outcomes include analysis of fMRI patterns of dyspnoea across populations, patient-reported burden of participation, and correlation between dyspnoea and psychological symptoms. These preliminary data will help determine the sample size required for a future study evaluating differences in dyspnoea patterns. Exploratory comparison between the characteristics of all four groups will be assessed with Fisher’s test (for proportions) and either independent Student’s t-test or Mann-Whitney test, depending on distribution. Correlations between variables will be tested using the Pearson’s correlation coefficient. Statistical analysis will be performed using STATA.
This study protocol received ethical approval on 23 April 2025 from the Commission cantonale d’éthique de la recherche in the Canton of Geneva, Switzerland. The identification number is 2024-02289. Submission to peer-reviewed journals and presentation in international congresses for the dissemination of the study findings are planned.
Clinical Trials number is NCT07319039; Pre-results.
Pain is a prevalent symptom in people living with dementia. Evidence shows that pain frequently remains unrecognised and untreated in this vulnerable population, leading to avoidable suffering. Effective pain management is hindered by multifactorial barriers at the individual, organisational and policy level. This study aims to achieve expert consensus on the key barriers to pain management in non-verbal people living with dementia and strategies to address these barriers within Portuguese residential care facilities.
An e-Delphi study will be conducted using two rounds of online questionnaires. The Behaviour Change Wheel (BCW) framework guided the development of e-Delphi statements by linking identified determinants (i.e., barriers and facilitators) to intervention functions. Barriers were extracted from the literature reviews and mapped into the capability, opportunity and motivation–behaviour model. Intervention functions were then selected using the BCW linkage matrices and operationalised into practical strategies. A purposive and snowball sampling approach will be used to recruit a heterogeneous panel of experts across national residential care facilities, including nurses, physicians, managers and policymakers with relevant experience in dementia. During the e-Delphi rounds, participants will be invited to rate the relevance of each barrier and associated strategy(ies) on a five-point Likert scale and provide comments or suggestions. Consensus will be defined as ≥75% agreement on each statement.
Ethical approval for this study was obtained from the Egas Moniz Ethics Committee (Ref. 1586), and all procedures will comply with the Declaration of Helsinki. Informed consent will be obtained from all participants. The findings will be disseminated through a peer-reviewed publication, scientific events and stakeholder networks, including residential care facilities, to inform future practice and policy in dementia care.