Music therapy as an adjunct in cardiac device lead extraction procedures: A randomized controlled trial.

BACKGROUND: Evidence of music therapy as an effective supportive therapy in invasive cardiac procedures is increasing, but more research is needed. AIMS: To evaluate the impact of music therapy on stress responses during cardiac device lead extraction procedures performed in local anaesthesia. METHODS: Sixty-four patients undergoing cardiac implantable electronic device lead extraction at Oslo University Hospital Ulleval from March 2018 to September 2019 were randomized to music therapy (n = 32) or control (n = 32). Primary endpoints were patient satisfaction with pain management and average pain intensity during the procedure. Secondary endpoints were average anxiety intensity, need for analgesic/anxiolytic drugs, blood pressure, heart and respiration rate. RESULTS: All patients in the music therapy group completed the intervention. Patient satisfaction with pain management was 10.00 (8.00, 10.00) in the music therapy vs. 10.00 (9.00, 10.00) in the control group (p = 0.85), and average level of pain 0.89 (0.22, 1.13) vs. 0.96 (0.36, 1.58), respectively (p = 0.38). Average anxiety score was 1.00 (0.33, 2.17) in the music therapy vs 1.67 (0.71, 3.35) in the control group (p = 0.056). The use of analgesic/anxiolytic drugs and physiological parameters were similar across groups. CONCLUSIONS: In this study of music therapy during cardiac device lead extractions, no effect was found on patient satisfaction with pain management or average pain level. A decrease in patient anxiety of borderline significance was observed in the music therapy group. More studies with more sensitive measures of pain and anxiety are needed to determine the value of music therapy in invasive cardiac procedures.