Competency assessment tools are well-recognised as a method to achieve a standardised level of practice for a group of healthcare professionals with similar characteristics. The aim of this study is to develop and pilot a new competency assessment tool to support therapists caring for patients with blunt chest trauma from prehospital care through to long-term follow-up following hospital discharge.

A mixed-methods study will be undertaken, with three distinct phases: (1) an integrative narrative review to examine the literature regarding therapist competencies; (2) focus groups with patients, therapists and key stakeholders to explore opinions regarding important aspects of care (phases I and II will inform the content of the tool), followed by final tool development by an international expert panel; and (3) a multicentre pilot study using questionnaires and elicitation interviews, in which final tool acceptability to therapists will be tested. The total sample size will be between 40 and 50 participants for the focus groups. For the final tool development work, a panel of 10 international experts will be identified, with a subgroup of 3–5 experts who will be recruited to confirm content validity. We will pilot the tool at five health boards in Wales, aiming for 10 therapists from each. Elicitation interviews will be undertaken with a smaller sample size of between 15 and 20 therapists. A mixed qualitative and quantitative data analysis approach will be used.

Proportionate ethics approval has been granted (South Yorkshire Research Ethics Committee, reference number: 24/YH/0231). We will publish the work in an open-access peer-reviewed journal to ensure equitable access and present at relevant conferences. Webinars will be used to achieve a wide audience. The results will be shared with the research participants via an infographic which will be designed and developed with the public research partners.

Integrative review is registered at the Open Science Framework: https://doi.org/10.17605/OSF.IO/CEXNR

Chronic non-cancer pain presents a global health problem, with a significant increase in opioid prescriptions over recent decades. However, opioid therapy poses risks of adverse events, overdose and non-medical use. As a result, many patients seek to discontinue or reduce their opioid intake. Strategies for opioid tapering often lack efficacy, prompting the investigation of novel approaches like open-label placebo (OLP), that is, the administration of a placebo with full disclosure that it is a placebo. OLP has shown efficacy in chronic non-cancer pain syndromes and has been suggested as a promising candidate for medication tapering. This study aims to assess whether OLPs can enhance the reduction of daily morphine equivalent dose (MED) in chronic non-cancer pain patients and examines its potential in mitigating opioid withdrawal symptoms.

This study is designed as a randomised, controlled, single-centre trial. Participants will be randomised into either an OLP group or a control group. The study duration will span six to nine weeks, during which all participants will aim to reduce their opioid intake. Both groups will monitor their opioid intake daily using a diary app and will receive feedback on their progress of reducing opioids. Additionally, participants in the OLP group will receive OLP tablets for the entire study period. During the first week, the OLP group will undergo a one week learning phase using a classical conditioning paradigm, where each opioid intake is paired with a placebo. In the subsequent five weeks, the OLP group will enter a dose-extension phase in which only the first opioid intake of the day is paired with a placebo, and additional placebos can be taken as desired. At the end of the study, qualitative interviews will be conducted with the first 15 participants in the OLP group. The primary outcome measure is daily opioid intake. Secondary outcomes include opioid withdrawal symptoms, pain severity, disability, anxiety, depression, opioid beliefs, intervention expectancy and qualitative data. Statistical analyses will include analysis of covariance and regression models.

The ethics committee of the Canton of Zurich, Switzerland, approved the study (SNCTP-nr.: SNCTP000005853/BASEC nr.: 2023–02327).

Participants will be compensated with 100 Swiss Francs for their full participation in the study. Participants who will take part in the qualitative interview will be compensated with additional 15 Swiss Francs.

This study is registered at clinicaltrials.gov: NCT06350786.