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Testing Psychological Interventions Through a Randomized Controlled Trial

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By: & Published: 2020 | Product: SAGE Research Methods Cases: Medicine and Health
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Abstract

Thus far, rehabilitation programs for people post-acute myocardial infarction (AMI) have not sufficiently addressed psychosocial factors such as stress, anxiety, and depression. Such factors could trigger the development of AMI or aggravate the existing AMI symptoms. In this case study, the researchers developed a symptom self-management program that aimed to help people post AMI recognize and manage the psychological factors. The efficacy of the newly developed program on physical and psychological outcomes was examined using a randomized controlled trial (RCT). The two methods of delivery, face-to-face and virtual reality-based approaches, were studied at a tertiary hospital in Singapore. Inclusion criteria included participants who were, (a) inpatients with stable post-AMI status, (b) 21–65 years of age, and (c) able to communicate in English. Eligible participants were randomly assigned to the three groups: IManage-VR, IManage-FF, or control group. The IManage-VR and IManage-FF groups received two 1-hr sessions of symptom self-management program through a virtual-reality device and face-to-face method, respectively. The control group received only standard care. Data were collected through a self-reported questionnaire and physiological measurements. Statistical analyses were conducted using analysis of covariance (ANCOVA) and repeated-measured analysis of variance (RMANOVA). The process of conducting RCT is elaborated in this case study.

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Randomized controlled trials

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