Methods: Randomized to GI or control groups, patients (N=21, mean age 30±8 years [21-47], 95% African American, 67% female) participated in pre-post clinical trial. At baseline patients completed the valid and reliable PAINReportIt®,3, 4 a computerized version of the McGill Pain Questionnaire,5 which includes questions to measure patients’ demographics. Patients completed current stress and current pain measures. They provided swab derived saliva samples for baseline cortisol measurements. The GI group was instructed to view a 12 min GI video after pretest measures via a Galaxy Internet-enabled tablet. For example, the GI video clips focus on “breathing out worry, breathing in light” and guide the patients to “Notice the cloud-like formations on the screen.” Patients viewed colorful smoke-like images that slowly changed shapes against a dark background (images, therefore, do not represent any concept with potential negative connotations), listened to soothing female voice, and followed slow-paced guided imagery instructions. The control group was instructed to record their sickle cell experience on the tablet for 12 min to control for attention. The audio-taped questions were self-administered and had onscreen directions (click to hear the next question) and patients’ responses were automatically captured via the computer microphone. After intervention per group assignment, patients provided swab derived saliva samples for cortisol measurements at 0 min and 30 mins. We analyzed the data using multi-level regression analysis to determine the effects of GI on current stress, current pain, and cortisol concentrations. Salivary cortisol was measured in duplicate by enzyme-linked immunosorbent assay (ELISA).6
Results: We found that 100% (n=21) of consented patients actually participated and completed the study, 100% of the PAINReportIt and other questionnaire items were completed, and 100% reported that they liked the intervention. There was a statistically significant effect of GI on stress (p<.01) and a trend for positive effects of GI on pain (p=.22). As figure 1 shows, the effects of GI on cortisol concentrations, current stress, and current pain indicate that the GI group scores improved more than the control group following the intervention compared to the control group. Cortisol concentrations varied considerably in this small sample and despite random assignment to groups, the GI group had considerably higher concentrations at baseline.
Conclusion: The study protocol was feasible in this vulnerable population. Based on these results, we are able to determine the effect size for the GI intervention and calculate the sample size needed to conduct an efficacy trial of GI intervention using this protocol in adults with SCD and to extend it to a longer-term study with patient using the mobile GI anywhere and anytime they encounter stressful situations. Findings from this promising feasibility study show that patients kept the scheduled study appointments and completed a simple and cost-effective trial of GI intervention on the mobile tablet device; the GI intervention reduced the impact of stress on SCD pain. Findings thus far are consistent with the HPA axis theory and support our hypothesis that a single 12-min GI intervention session is sufficient to reduce current stress and pain. Consequently, GI could be used to control pain during emergency department and acute care center visits while patients are waiting to be evaluated for further pain management. Findings have potential to inform cognitive-behavioral strategies for stress and pain reduction in this vulnerable population.
References
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6. Enzyme-linked immunosorbent assay (ELISA) Salimetrics, State College, PA.