Noise, doubt, empathy or surprise? A qualitative collective self-study exploring the phenomenon of disruption in clinical trials

Abstract

Disruptions, i.e. things or events that interrupt the normal or expected, may be experienced as something positive, but also as something negative. They are an integral part of clinical trials, often representing ethical challenges. As researchers, we are the agents of disruption: we intervene in participants’ lives by implementing interventions and collecting data; we engage stakeholders and ask colleagues for support. How do these disruptions affect the researchers themselves? In this study, we explore disruptions from a researcher’s perspective in a qualitative self-study of our experiences while working together on an international randomised controlled trial. The data comprises qualitative interviews with us, the music therapy research team in the Norwegian partner institution of the trial. The interviews were analysed using a collaborative reflexive thematic analysis. Four themes, representing different types of disruption and qualities in our experiences of them, were identified: background noise, rejection, empathic disruption, and disruptive dissonance. These themes share the characteristics of being relational, sometimes ambiguous, and influencing each other, requiring interpretation in context. This complexity makes them challenging to define and navigate. We argue that continuous reflection on different disruptions and negotiation of their boundaries are vital to ensure high ethical research standards and to support researchers’ self-care.