Serious gaming during multidisciplinary rehabilitation for patients with complex chronic pain or fatigue complaints: study protocol for a controlled trial and process evaluation

Abstract

IntroductionMany individuals suffer from chronic pain or functional somatic syndromes and face boundaries for diminishing functional limitations by means of biopsychosocial interventions. Serious gaming could complement multidisciplinary interventions through enjoyment and independent accessibility. A study protocol is presented for studying whether, how, for which patients and under what circumstances, serious gaming improves patient health outcomes during regular multidisciplinary rehabilitation.Methods and analysisA mixed-methods design is described that prioritises a two-armed naturalistic quasi-experiment. An experimental group is composed of patients who follow serious gaming during an outpatient multidisciplinary programme at two sites of a Dutch rehabilitation centre. Control group patients follow the same programme without serious gaming in two similar sites. Multivariate mixed-modelling analysis is planned for assessing how much variance in 250 patient records of routinely monitored pain intensity, pain coping and cognition, fatigue and psychopathology outcomes is attributable to serious gaming. Embedded qualitative methods include unobtrusive collection and analyses of stakeholder focus group interviews, participant feedback and semistructured patient interviews. Process analyses are carried out by a systematic approach of mixing qualitative and quantitative methods at various stages of the research.Ethics and disseminationThe Ethics Committee of the Tilburg School of Social and Behavioural Sciences approved the research after reviewing the protocol for the protection of patients’ interests in conformity to the letter and rationale of the applicable laws and research practice (EC 2016.25t). Findings will be presented in research articles and international scientific conferences.Trial registration numberA prospective research protocol for the naturalistic quasi-experimental outcome evaluation was entered in the Dutch trial register (registration number: NTR6020; Pre-results).

Effectiveness of transcutaneous electrical nerve stimulation in management of neuropathic pain in patients with post traumatic incomplete spinal cord injuries

“…TENS is primarily aimed to provide a degree of symptomatic pain relief by exciting sensory nerves. 21 - 22 The effectiveness of TENS varies with the clinical pain being treated, but research suggest that when used ‘well’ it provides significantly greater pain relief than a placebo intervention. 23 …”

Effectiveness of Serious Gaming During Multidisciplinary Rehabilitation for Patients with Complex Chronic Pain or Fatigue: A Natural Quasi-experiment (Preprint)

“…A protocol for this embedded experimental mixed-methods study was registered (pre-results) in the Dutch trial register (NTR6020), previously published in detail [17], and followed accordingly. General information and important executive details relevant for the present objectives are presented here.…”

“…Study size was determined by a priori power calculation as described in detail in the protocol [17]. G*Power was used to calculate a required sample size of 212 patients.…”

“…Herein, a contribution may be made by the pragmatic effectiveness evaluation of a serious gaming intervention (i.e. LAKA) during multidisciplinary rehabilitation for patients with emotional or role dysfunctions in association with chronic pain and/or fatigue [17]. It is hitherto unknown if serious games complement other 2 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 61 62 63 64 65 66 67 68 69 70 71 72 73 74 75 76 77 78 79 80 81 82 83 84 85 86 87 88 3 treatment modes in facilitating intervention effects that are meaningful for patients, to what extent, and in what respect, when offered in addition to other modes of treatment as in regular outpatient multidisciplinary rehabilitation.…”

Effectiveness of Serious Gaming During the Multidisciplinary Rehabilitation of Patients With Complex Chronic Pain or Fatigue: Natural Quasi-Experiment

“…A major challenge is to identify which behavior change intervention approaches [ 11 ], techniques [ 12 ], and delivery modes (eg, computer based) are most accessible and (cost-)effective for certain patients in certain health care settings [ 13 , 14 ]. Herein, a contribution may be made by the pragmatic effectiveness evaluation of a serious gaming intervention (ie, LAKA) during multidisciplinary rehabilitation for patients with emotional or role dysfunctions in association with CP or fatigue [ 15 ]. It is hitherto unknown whether, to what extent, and in what respect serious games complement other treatment modes in facilitating intervention effects that are meaningful for patients when offered in addition to other modes of treatment as in regular outpatient multidisciplinary rehabilitation.…”