3D-Assisted Personalized Digital Patient Education Before Elective Lumbar Fusion: Effects on Decisional Conflict, Resilience, and PROMs in a Prospective Randomized Parallel-Group Study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00040479

Enrollment

Registered

2026-06-08

Start date

2026-07-01

Completion date

Unknown

Last updated

2026-06-22

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

Conditions

M42.16

Interventions

Group 1: In Arm 1, patients receive standardized, script-based preoperative patient education before elective posterior lumbar fusion. In addition to conventional patient education, a patient-specific

the only difference is the additional use of personalized 3D visualization. Group 2: In the control group, patients receive standardized, script-based preoperative patient education before elective po

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Planned elective posterior lumbar spinal fusion involving 1 or 2 segments Sufficient German language skills to participate in patient education and questionnaire assessments Written informed consent to participate in the study

Exclusion criteria

Exclusion criteria: Emergency hospital admission or urgent surgery Infectious cause of the spinal disorder Tumor-related indication, including primary or secondary tumor disease or spinal metastases Previous lumbar spinal fusion surgery

Design outcomes

Primary

Measure	Time frame
Decisional Conflict Scale (DCS) at T1, 1–2 days before surgery. The DCS is a validated questionnaire used to assess uncertainty and conflict in the medical decision-making process, including informedness, values clarification, support, and decisional certainty. Data collection will be conducted using questionnaires.	—

Secondary

Measure	Time frame
Knowledge check assessing understanding of the patient education content at T1 Preoperative anxiety at T1 using the Amsterdam Preoperative Anxiety and Information Scale Brief Resilience Scale and Resilience Scale 13 at T0, T3, and T4 ODI, NRS, and SF-36 at T0, T2, T3, and T4 Pain medication according to the WHO analgesic ladder at T0, T2, T3, and T4 Perioperative and postoperative complications during hospitalization up to T2; new complications up to T3/T4 Reintegration and daily functioning at T3 and T4 using the Return to Normal Living Index (RNLI)	—

Measure

Time frame

Knowledge check assessing understanding of the patient education content at T1 Preoperative anxiety at T1 using the Amsterdam Preoperative Anxiety and Information Scale Brief Resilience Scale and Resilience Scale 13 at T0, T3, and T4 ODI, NRS, and SF-36 at T0, T2, T3, and T4 Pain medication according to the WHO analgesic ladder at T0, T2, T3, and T4 Perioperative and postoperative complications during hospitalization up to T2; new complications up to T3/T4 Reintegration and daily functioning at T3 and T4 using the Return to Normal Living Index (RNLI)

—

Countries

Germany

Contacts

Public ContactMate Kiss

Charité – Universitätsmedizin Berlin, Klinik für Neurochirurgie

mate-tamas.kiss@charite.de+491631863381

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Jun 29, 2026