Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID07415889

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Your Study Journey

Screening

Duration - Up to 2 weeks after surgery

Participants are screened for eligibility to participate in the trial.

1 screening and enrollment visit

Treatment

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

Follow-up

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

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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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