Immersive Multimedia as an Adjunctive Measure for Pain Control in Cancer Patients

Titre officiel

Immersive Multimedia as an Adjunctive Measure for Pain Control in Cancer Patients

Sommaire:

Cette étude vise à examiner l’efficacité des expériences de réalité virtuelle (RV) comme intervention thérapeutique d’appoint pratique pour l’autogestion de la douleur chronique chez les survivants du cancer. Une étude d’intervention comparative contrôlée et une étude descriptive-interprétative qualificative seront menées auprès de 100 survivants du cancer qui ressentent une douleur chronique. Les participants seront répartis de façon aléatoire entre un groupe soumis à un traitement par réalité virtuelle (RV) et un groupe témoin traité par multimédia immersif (50 sujets par groupe). Ces participants seront soumis à une série d’expériences de réalité virtuelle ou à des séances multimédia 2D dans leur domicile, durant une période d’un mois. Les interventions seront réalisées tous les jours pendant un mois en vue de personnaliser le traitement et de recueillir des données sur une période suffisamment longue pour déceler tout changement à court terme dans le niveau de douleur. Les séances de RV consisteront à explorer des environnements immersifs interactifs à l’aide d’un visiocasque de RV et d’un ordinateur. Le groupe témoin sera exposé à des expériences multimédia 2D comparables (sans visiocasque de VR) sur ordinateur domestique. Le niveau de douleur avant, pendant et après les interventions, de même que la qualité du sommeil, seront évalués à l’aide d’outils normalisés. À la fin de l’étude, les dix sujets qui auront affiché les gains les plus marqués en termes de réduction de la douleur grâce aux expériences de RV seront sélectionnés et invités à participer à un volet visant à évaluer tout changement mesurable de l’activité neurologique au moyen d’examens d’imagerie par résonance magnétique (IRM) réalisés avant et après les interventions.

Description de l'essai

Primary Outcome:

  • Change in Visual Analog Score for Pain
Secondary Outcome:
  • Neuronal Activity
  • McGill Pain Questionnaire
This study seeks to explore the efficacy of an immersive multimedia experience as a practical therapeutic intervention in the self-management of the chronic pain associated with cancer patients. This work will inform further clinical studies and future research into the potential uses of immersive multimedia in the treatment of cancer associated pain. Furthermore, it will help identify optimal immersive multimedia environments for use in chronic pain applications, practical determinants for implementation of immersive multimedia for wider practice, and will provide a better theoretical understanding of the mechanisms whereby immersive multimedia works in chronic pain. JUSTIFICATION Cancer survivorship refers to individuals who have remained cancer free for a minimum of 5 years. Due to developments and greater outcomes associated with cancer therapy and management, the number of individuals who survive cancer has risen considerably over the past decade. Currently, 65% of adults and 80% of children can be expected to live at least 5 years post cancer diagnosis. However, for some, survivorship is associated with debilitating chronic pain which impacts negatively on quality of life. Reviews have suggested that up to 40% of individuals have survived cancer remain with cancer related chronic pain. With rapidly emerging immersive multimedia technologies and clinical work in this field, it would appear that immersive multimedia may have significant potential for use as an adjunctive therapeutic measure for pain control. However, there has been little work done to establish the potential use of immersive multimedia in the management of chronic cancer pain to date, as most work on immersive multimedia for pain management has focused on acute pain via distraction. Several researchers have recommended the investigation of immersive multimedia for chronic, long term pain, and the research team completed a pilot study in 2015 to establish best methods and approaches for using immersive multimedia in chronic pain conditions. OBJECTIVES To determine if immersive multimedia therapy is effective as an adjunctive intervention in the management of chronic pain in cancer patients? 1. Can exposure to a immersive multimedia environment as an adjunctive pain-relieving measure provide a pain-reducing experience for for chronic cancer pain patients? 2. How long (if at all) do any therapeutic effects of immersive multimedia last after exposure in chronic cancer pain patients? 3. Are there any significant side effects of immersive multimedia exposure for chronic cancer pain patients? 4. Do any identifiable neurological changes occur on fMRI pre and post immersive multimedia exposure? RESEARCH METHODS A longitudinal mixed-methods study to evaluate the impact of immersive multimedia for chronic pain in cancer patients is proposed which will consist of a comparative controlled interventional trial and qualitative interpretative-descriptive exploration. 1. Interventional Trial (Quantitative): Participants will be randomly assigned to either a VR therapy group or the control group (50 subjects in each). They will undertake either a series of immersive VR interventions, or control sessions (using 2D multimedia on personal computers) in their own homes over a period of a month. To ensure the multi-dimensional aspects of chronic pain experienced by individuals are measured adequately, pain assessment tools have been selected that will address different aspects of each participant's' chronic pain and functional capacity. To measure the impact of VR on each participant's pain intensity, the Visual Analog Scale will be used during the VR and control experiences, pre and post exposure and at 10 minute intervals. In order to measure the change in pain during the therapy experience, and overall sleep quality, at the end of each week, participants will also be asked to complete post-intervention questionnaires: Health Survey (Short-Form 12), McGill Pain Questionnaire, the Pittsburgh Sleep Quality Index, and also a brief Virtual Reality Immersion Tool (to assess how immersive they found the experience that week). 2. Interpretive Description Study (qualitative): A Qualitative Interpretative- Descriptive exploration will be undertaken alongside the trial to allow for a more open exploration of participants experiences and to further understanding of the perceptions associated with the use of immersive multimedia and any impact upon their chronic pain. An interpretative description (ID) approach will be used for this aspect of the study. This methodology allows for an inductive descriptive analysis of the phenomena, and was chosen as it is ideal for small scale studies, allowing for generation of themes, patterns and theory associated with the patient's experience. Following the completion of the clinical trial all participants will be sent an exploratory questionnaire to discover their perceptions of immersive multimedia and its value (if any) in the control of their chronic pain. In this questionnaire they will also be invited to participate in one of two focus group interviews. Data from this will be analyzed and used to support purposeful sampling of individuals to take part in the following focus-group interviews, to include those subjects with a range of diverse opinions and ideas. As themes and categories emerge from the data the researchers will seek to adapt the focus-group interview sample with the purpose of strengthening the emerging theory and patterns by including individuals who will help further define the characteristics of these themes and categories. Data Analysis Quantitative Data: Descriptive and inferential statistical analysis will be performed on the pain scores. For face-value quantitative indicators of potential effects univariate descriptive statistics will be employed. Data will be analyzed for central tendency, dispersion (standard deviation, interquartile range), skewness and kurtosis using SPSS statistical analysis software to establish distribution and variance. Likewise, quantitative data from the questionnaires will be analysed in this fashion. Data will be explored for differences in the pain scales for the VR group and the control group at each time point to analyze for any indications of changes immediately following the experience using Linear Mixed Effects Modelling using SPSS software. Qualitative Data: The focus-group interviews will be audiotaped. The questionnaire open text results and transcriptions of focus groups will be recorded into NVivo 11.0 qualitative data analysis software and read, re-read and coded for thematic elements by the PIs.

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