ABSTRACT
OBJECTIVE: To test the feasibility of a randomized-controlled trial measuring the impact of an adapted mindfulness-based intervention (MBI) in female adolescents with chronic pain. METHODS: This was a single center, single-blind, prospective, experimental, longitudinal trial conducted in a pediatric tertiary care center. Participants had a history of chronic pain during at least three months. They were randomized into an intervention group or a wait-list control group. Both groups successively followed an adapted eight-week MBI designed specifically for adolescents with chronic pain. Pre-determined criteria were established to assess the feasibility, validity and acceptability of the study model. Data evaluating changes in quality of life, depression, anxiety, pain perception, psychological distress and salivary cortisol were collected throughout the 4-month study period. RESULTS: Nineteen female participants completed the study and had a mean age of 15.8 years (range 13.9 -17.8). Attrition rate was low (17%). Attendance to mindfulness sessions (84%) and compliance to study protocol (100%) were high. All participants reported a positive change in the way they coped with pain. No changes in quality of life, depression, anxiety, pain perception, and psychological distress were detected. Significant reductions in pre-and post-mindfulness session salivary cortisol levels were observed (p<0.001). CONCLUSIONS: Mindfulness is a promising therapeutic approach for which limited data exist in adolescents with chronic pain. Our study indicates the feasibility of conducting such interventions in teenage girls. A large trial is needed to demonstrate the efficacy and bio-physiological impacts of MBIs in teenagers with chronic pain.
OBJECTIF: Vérifier la faisabilité d'un essai randomisé contrôlé qui mesure l'effet d'une intervention de pleine conscience (IPC) adaptée chez des adolescentes souffrant de douleur chronique. MÉTHODES: Il s'agissait d'un essai monocentrique, à l'insu, prospectif, expérimental, longitudinal mené dans un centre soins tertiaires pédiatriques. Les participantes avaient des antécédents de douleur chronique durant au moins trois mois. Elles ont été randomisées soit dans un groupe d'intervention, soit dans un groupe témoin placé sur une liste d'attente. Les deux groupes ont suivi successivement une IPC adaptée de 8 semaines, conçue spécifiquement pour les adolescentes souffrant de douleur chronique. Des critères prédéterminés ont été établis pour évaluer la faisabilité, la validité et l'acceptabilité du modèle d'étude. Les données évaluant les changements touchant la qualité de vie, la dépression, l'anxiété, la perception de la douleur, la détresse psychologique et le cortisol salivaire ont été recueillies durant la période de 4 mois de l'étude. RÉSULTATS: Dix-neuf participantes ont participé à l'étude et leur âge moyen était de 15,8 ans (écart de 13,9 à 17,8). Le taux d'attrition était faible (17 %). L'assistance aux séances de pleine conscience (84 %) et l'observance du protocole de l'étude (100 %) étaient élevées. Toutes les participantes ont déclaré un changement positif de la façon dont elles traitaient avec la douleur. Aucun changement n'a été détecté en ce qui concerne la qualité de vie, la dépression, l'anxiété, la perception de la douleur, et la détresse psychologique. Des réductions significatives des taux de cortisol salivaire avant et après les séances de pleine conscience ont été observées (p < 0,001). CONCLUSIONS: La pleine conscience est une approche thérapeutique prometteuse pour laquelle il n'existe que des données limitées pour les adolescentes souffrant de douleur chronique. Notre étude indique la faisabilité de mener ces interventions auprès d'adolescentes. Il faut un vaste essai pour démontrer l'efficacité et les effets biophysiologiques des IPC chez les adolescentes souffrant de douleur chronique.
ABSTRACT
BACKGROUND: Individuals living with cancer must learn to face not only the physical symptoms of their condition, but also the anxiety and uncertainty related to the progression of the disease, the anticipation of physical and emotional pain related to illness and treatment, the significant changes implied in living with cancer, as well as the fear of recurrence after remission. Mindfulness-based meditation constitutes a promising option to alleviate these manifestations. METHODS/DESIGN: This article presents the rationale and protocol development for a research project aimed at evaluating the effects of a mindfulness-based meditation intervention on quality of life, sleep, and mood in adolescents with cancer compared to a control group. A prospective, longitudinal, experimental design involving three time points (baseline, post-intervention, and follow-up) and two groups (experimental and control) was developed for this project. Participants will be assigned randomly to either group. Eligible participants are adolescents aged 11 to 18 years with a diagnosis of cancer, with no specific selection/exclusion based on type, stage, or trajectory of cancer. A final sample size of 28 participants is targeted. Adolescents in the experimental group will be completing the mindfulness meditation intervention, taught by two trained therapists. The intervention will comprise of eight weekly sessions, lasting 90 min each. Once the follow-up assessment is completed by the experimental group, wait-list controls will be offered to complete the mindfulness-based program. Intra-group analyses will serve to evaluate the impact of the mindfulness-based meditation intervention on quality of life, sleep, and mood pre-post intervention, as well as follow-up. Analyses will also be used to carry out inter-group comparisons between the experimental group and the wait-list controls. Voluntary participation, risk of attrition, and the small sample size are potential limitations of this project. In spite of possible limitations, this project will be one among very few aimed at improving quality of life, sleep, and mood in adolescents living with cancer, will evaluate the potential benefits of such a practice on both psychological and physical health of youth with cancer, and help in creating mindfulness-based intervention programs, in order to provide the necessary psychological help to adolescents living with cancer. TRIAL REGISTRATION NUMBER: NCT01783418.
