Assessing the Functional Benefit of Structured Psychological Coaching in Mentally Vulnerable Patients With a Surgically Treated Proximal Humerus Fracture.

Introduction The primary objective of this study is to investigate whether psychological guidance, additionally to the standard care, given to patients with neuroticism that sustained a proximal humerus fracture, influences functional outcomes. The secondary objectives are to study if psychological guidance will lead to a better range of motion, lower pain levels, less use of pain medication, faster return to work, improvement in fear for movement, anxiety, depression, acceptance, self-efficacy, resilience, negative pain cognitions and better general health.

Methods This study is designed as a multicenter, prospective randomized controlled trial. Due to the nature of this study, it will be a single blinded study, the researchers will be blinded.

All patients with a PHF will be given information about the study via their physician and if they are eligible they are provided with the patient information form. The physician will notify the researcher and the researcher will call the patients to give more information about the study if needed and will ask for consent. Following consent neuroticism will be tested via the NEO-FFI. If patients score average or (very) low on neuroticism the patients will be thanked for filling in the questionnaire and will be told they are not eligible for the study. If patients score (very) high on neuroticism the researcher will ask the patient to participate. The researcher will give the patient up to seven days to consider participating in the study. After this period, the researcher will contact the patient again to obtain informed consent. If consent is given, another researcher will later randomize the patient into either the control group or the treatment group.

Intervention The control group will undergo the standard postoperative care consisting of multiple outpatient clinic visits with their surgeon where they will make additional radiographic pictures if needed and will look for early complications. Besides the visits with their surgeon the patients will have visits at 3, 6 and 12 months with a researcher or their surgeon. Besides the visits all the patients will be referred to a physical therapist. The intervention group will undergo the standard postoperative care and will additionally get psychological guidance given by licensed psychologists. The psychological guidance will consist of eight sessions over a duration of six months and starts two to three weeks after surgery.

Randomization and blinding When the patient provides informed consent, they will be randomly assigned (1:1) to the intervention (psychological training) group or the control group (standard follow up) using a web-based application with a computer-generated list. Participants are aware of allocation; masking is impossible because of the nature of the intervention. Investigators doing the follow up appointments are not aware of allocation. The investigator who will randomize the participants will be aware of allocation but will not take part in obtaining the data or the analysis of the data. We will employ an intention to treat analysis.