Efficacy of an mHealth intervention to support pain self-management and improve analgesia in patients with rib fractures: protocol for a randomised controlled trial.

Introduction: In light of the risks of over-reliance on opioid analgesia during recovery from rib fractures, there is increased interest in the efficacy of non-pharmacological approaches to pain management. This paper describes the protocol for a double-blind randomised controlled trial to evaluate the efficacy of an mHealth intervention for reducing pain intensity, pain-related distress and opioid use during early recovery from rib fractures.

Methods And Analysis: Adults (N=120) with isolated rib fractures will be recruited within 24 hours of admission to a large public hospital in Sydney, Australia (single site), and randomised (1:1 allocation) to an intervention or active control group. Clinicians, participants and statisticians will be blind to participants' group allocation. The intervention (PainSupport) consists of a brief pain self-management educational video, followed by twice daily supportive Short Message Service (SMS) text messages for 14 days. Participants in the active control group receive the same video but not the supportive text messages. Participants in both groups continue to receive usual care throughout the trial. The primary outcome will be self-reported pain intensity on respiration measured using a Numerical Rating Scale. Secondary outcomes will include opioid use, pain-related distress, adherence to behavioural pain management strategies and the acceptability and feasibility of the intervention. Participants will complete questionnaires at baseline and then on days 1-7 and day 14 of the trial. A feedback survey will be completed at the end of the trial (day 15). Linear mixed models will be used to evaluate the main effect of the group on the primary and secondary outcomes and to explore differences between outcome trends recorded over the trial. Analyses will be based on the intention-to-treat principle to minimise bias secondary to missing data or dropouts.

Ethics And Dissemination: The study protocol has been reviewed and approved by the Northern Sydney Local Health District Human Research Ethics Committee (Australia). Informed consent is a requirement for participation in the study. Study results will be published in peer-reviewed journals and presented at scientific and professional meetings.

Trial Registration Number: ACTRN12623000006640.