Randomized Control Trial Model

Decent Essays
The proposed study will be a quantitative pilot randomized control trial design to determine the feasibility and acceptability of the interventions, methodology and evaluation methods, as well as provide data to facilitate a randomized control study (Feely, et al., 2009). The study will evaluate the effects of the intervention on nerve impulse transmission to the brain, described in the pain gate theory, through comparison of preschool children’s perception of pain and physiological response in children (Moayedi & Davis, 2013; Tansky & Lindberg, 2010). The comparison will evaluate if children who receive distraction, through nurse led singing, pain perception and response differs from children who receive basic intervention while receiving a intramuscular immunization (Moayedi & Davis, 2013; Tansky & Lindberg, 2010). The dependent variable will be defined as the self-report of pain through utilization of tools successful in evaluating pediatric pain: the Wong-Baker FACES Pain Rating Scale and a Visual Analogue Scale (Garra, et al., 2010). A secondary outcome is defined as a change in pulse, respiration rate and blood pressure. Vital signs will be taken at three time intervals during immunization: five minutes prior,…show more content…
Limitations to the participants include: up to date immunizations, no barriers to communication, no developmental delays, no chronic illness and no recent hospital admissions. The proposed study will be monitored with audio videotaping to assess feasibility of how the intervention was administered and to examine intervention fidelity and study protocol through watching the recorded video to ensure interventions were administered accurately and precisely (Feeley, et al., 2009; McQueen, Dennis, Stremler, & Norman, 2011). Thus, the following research questions will be
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