Title {1} | Effect of perioperative cognitive behavioural therapy on chronic postsurgical pain among breast cancer patients with high pain catastrophising characteristics: study protocol for a double-blinded randomised controlled trial. |
Trial registration {2a and 2b}. | This trial was pre-registered on ClinicalTrials.gov on 11 June 2021. Identifier number: NCT04924010. All items from the World Health Organisation Trial Registration Data set have been included. https://clinicaltrials.gov/ct2/show/NCT04924010 |
Protocol version {3} | Protocol version 2: 05 February, 2021 |
Funding {4} | This trial is being funded internally from the division of Anaesthesiology & Perioperative Medicine, Mater University Hospital. No external funding sourced. |
Author details {5a} |
(1). Dr Aneurin Moorthy*: Anaesthesia research fellow, Division of Anaesthesiology & Perioperative Medicine, Mater University Hospital, Dublin, Ireland; aneurin.moorthy@gmail.com (Correspondence). *Co-first author (2). Dr Damien Lowry*, Chartered Senior Counselling Psychologist, Depts of Psychology and Pain Medicine, Mater Misericordiae University Hospital. *Co-first author (3). Dr Carla Edgley, University College Dublin, School of Medicine. (4). Dr Maire-Brid Casey, Senior Physiotherapist, Mater Misericordiae University Hospital. (5). Professor Donal J. Buggy**: Consultant Anaesthesiologist, Division of Anaesthesiology & Perioperative Medicine, Mater University Hospital, School of Medicine, University College Dublin, Ireland; and Outcomes Research, Cleveland Clinic, OH, USA. donal.buggy@ucd.ie. **Principal investigator |
Name and contact information for the trial sponsor {5b} | Division of Anaesthesiology & Perioperative Medicine, Division of Anaesthesiology & Perioperative Medicine, Mater University Hospital, Dublin, Ireland. Email: anaes@mater.ie, Office: 003531803 2286/2281 |
Role of sponsor {5c} | This is a hypothesis-driven, investigator-initiated trial. Therefore, the funders played no role in the design of the study, data collection, analysis, interpretation of data or in the writing of the manuscript. |