Actively Recruiting
Assessing the Functional Benefit of Structured Psychological Coaching in Patients With Surgically Treated Proximal Humerus Fractures and High Neuroticism
Led by Zaandam Medical Center · Updated on 2026-02-17
70
Participants Needed
4
Research Sites
N/A
Total Duration
On this page
Sponsors
Z
Zaandam Medical Center
Lead Sponsor
A
Amsterdam University Medical Center
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating the impact of psychological guidance on patients with neuroticism who have undergone surgery for proximal humerus fractures. The study focuses on whether adding focused cognitive behavioral therapy to standard care can improve functional outcomes, reduce pain and anxiety, and enhance overall health. Mental vulnerability related to neuroticism has been linked to poorer health outcomes, and this trial aims to address this gap by providing psychological support. Participants are randomly assigned to one of two groups: one receiving standard postoperative care including surgery, pain management, outpatient visits, and physical therapy; the other receiving the same standard care plus eight sessions of psychological guidance over six months. The therapy sessions include psychoeducation, relaxation techniques, coping strategies, and are delivered by licensed psychologists either in-person or via videocall. During the study, participants will be assessed at 3, 6, and 12 months after surgery using various measures including the Constant Shoulder Score, Oxford Shoulder Score, pain levels, range of motion, psychological factors like anxiety and resilience, and general health. Safety monitoring includes tracking adverse events throughout the follow-up period. The total participation duration spans one year with multiple evaluations to monitor recovery and psychological changes.
CONDITIONS
Brief Title
Assessing the Functional Benefit of Structured Psychological Coaching in Mentally Vulnerable Patients With a Surgically Treated Proximal Humerus Fracture.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Surgically treated proximal humerus fracture not older than two weeks
- High or very high level of neuroticism as measured by NEO-FFI test (score of 37 or above)
- Age 18 years or older
- The fracture is a single injury, not part of multiple injuries
You will not qualify if you...
- Diagnosed psychiatric disorder not adequately controlled with medication
- Inability to communicate due to language barriers or neurologic disorders
- Paralysis of the affected arm
- Unable to participate in online or real-time psychological training
- Presence of any other fracture in the upper extremity besides the proximal humerus
- Head trauma with neurological symptoms
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - Up to 2 weeks after surgery
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Duration - 6 months
Participants undergo standard postoperative care including multiple outpatient visits with their surgeon and referral to a physical therapist. Participants in the intervention group additionally receive psychological guidance consisting of 8 sessions over six months starting two to three weeks after surgery.
Multiple outpatient clinic visits with surgeon and physical therapist; 8 psychological sessions for intervention group
Duration - Up to 12 months after surgery
Participants attend follow-up visits to assess functional outcomes, pain levels, range of motion, psychological changes, and general health at 3, 6, and 12 months after surgery.
Visits at 3, 6, and 12 months post-surgery
Trial Site Locations
Total: 4 locations
1
Amsterdam University Medical Center
Amsterdam, Netherlands
Actively Recruiting
2
OLVG
Amsterdam, Netherlands
Not Yet Recruiting
3
Red Cross Hospital
Beverwijk, Netherlands
Not Yet Recruiting
4
Zaandam Medical Center
Zaandam, Netherlands
Actively Recruiting
Research Team
D
Denise E de Gruijter, MD
R
Robert Jan Derksen, MD, PhD, MSc
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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