Efficacy of a symptom self-management program with virtual reality device on inpatients post-acute myocardial infarction: A pilot randomized controlled trial (Preprint)
BACKGROUND Acute myocardial infarction (AMI) is a leading cause of morbidity and mortality worldwide. AMI is associated with poorer quality of life and other psychological symptoms (such as stress, depression and anxiety). Effective psychosocial interventions are essential to help patients post-AMI manage with the psychological symptoms. OBJECTIVE This study aimed to test the efficacy of a newly-developed symptom self-management program on health outcomes among inpatients post-AMI METHODS A pilot randomized, single-blinded, controlled trial was utilized. A convenient sample of 90 was recruited from a tertiary hospital in Singapore. Adult inpatients with stable post-AMI were randomly assigned to the following three groups: IManage-VR, IManage-FF or control group. The IManage-VR and IManage-FF groups received standard care and a symptom self-management program through virtual-reality device or face-to-face method respectively. Two researchers delivered the interventions and assisted with relaxation practice. The control group received only standard care. Data were collected through self-reported questionnaires and physiological instruments. Data analyses included univariate statistics, analysis of variance and repeated measure analysis of variance. RESULTS A total of 90 participants were recruited with 30 in each group. Results indicated that participants in the IManage-VR and IManage-FF group had significantly greater relaxation levels (Partial η2 = 0.11, 0.16), lower objective stress (Partial η2 =0.14, 0.06), and greater knowledge (Partial η2 = 0.62, 0.75) than those of the control group. The two intervention groups had lower subjective stress (Partial η2 = 0.04), depression (Partial η2 = 0.01), and anxiety (Partial η2 = 0.03) than the control but such differences did not achieve statistical significance. Furthermore, most participants (>90%) in the IManage-VR and IManage-FF groups reported that they were satisfied with the programs and they provided positive comments on the contents, educational materials and relaxation practice. CONCLUSIONS This pilot study supports the potential benefits and feasibility of the IManage-VR and IManage-FF interventions on stress, perceived relaxation, knowledge and patient satisfaction. Findings contribute to the current literature on psychosocial interventions for AMI where psychosocial educational materials could be added into the current cardiac rehabilitation programs. Future RCTs with multi-centered sites and larger sample size are required to further test the intervention. CLINICALTRIAL This study has been registered with International Standard Randomised Controlled Trial. Registration Number: ISRCTN61027816. http://www.controlled-trials.com/ ISRCTN61027816.