Assessing the functional benefit of structured psychological coaching in mentally vulnerable patients with a surgically treated proximal humerus fracture.

Assessing the functional benefit of structured psychological coaching in mentally vulnerable patients with a surgically treated proximal humerus fracture. - ELEVATE study

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON57809

Enrollment

Registered

2025-06-16

Start date

2025-12-02

Completion date

Unknown

Last updated

2026-06-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

emotional instability Neuroticism

Interventions

All patients in the control group as well as the intervention group will undergo surgery for their proximal humerus fracture and will start physical therapy after surgery. They will have outpatient

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. Surgically treated proximal humerus fracture, not older than two weeks 2. To have neuroticism (cut-off score on NEO-FFI test off 37) 3. Minimal age of 18 years 4. The fracture must be a mono-injury (not part of a multi-injury incident)

Exclusion criteria

Exclusion criteria: 1. Any diagnosed psychiatric disorders 2. Not being able to communicate: language barrier, neurologic disorders 3. Paralysis on the affected side 4. Not able to participate in online or real time psychological training 5. Any other fracture besides the proximal humerus fracture 6. Head trauma

Design outcomes

Primary

Measure	Time frame
Using the Constant Shoulder Score (CSS), Oxford Shoulder Score (OSS) and Quick Disabilities of the Arm, Shoulder and Hand (qDASH) to measure the functional outcomes.	—

Secondary

Measure	Time frame
The use of pain medication, rehabilitation time, time away from work, time not participating in normal daily activities as before the trauma, complications (infection, material failure, non-union, re-dislocation, avascular necrosis) and mortality, pain level at both sides (VAS), from 0 (no pain) to 10 (worst possible pain), and shoulder ROM (abduction, anterior flexion, internal and external rotation, measured using a goniometer) are recorded and analyzed as secondary outcome measures. The psychological changes will be measured using various psychological questionnaires (SF-36, CBRQ, WSAS, TSK, Self-efficacy scale, catastrophe scale, brief resilience scale, health cognition scale and HADS).	—

Measure

Time frame

The use of pain medication, rehabilitation time, time away from work, time not participating in normal daily activities as before the trauma, complications (infection, material failure, non-union, re-dislocation, avascular necrosis) and mortality, pain level at both sides (VAS), from 0 (no pain) to 10 (worst possible pain), and shoulder ROM (abduction, anterior flexion, internal and external rotation, measured using a goniometer) are recorded and analyzed as secondary outcome measures. The psychological changes will be measured using various psychological questionnaires (SF-36, CBRQ, WSAS, TSK, Self-efficacy scale, catastrophe scale, brief resilience scale, health cognition scale and HADS).

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Jun 11, 2026