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Enhancement of patient's autonomy by active role training with operative patients: Patient Active Role Training

Shared decision making in surgical patients

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN19208427
Enrollment
280
Registered
2008-07-11
Start date
2008-04-21
Completion date
Unknown
Last updated
2016-10-17

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

Conditions

Indication for operation in traumatology and general surgery Surgery Traumatology and general surgery

Interventions

The inclusion of the patients takes place in the anaesthesiology premedication clinic. After the education, a computer assisted questionnaire will be performed. This questionnaire contains a special q

Sponsors

Charite - University Medicine Berlin (Charite - Universitatsmedizin Berlin) (Germany)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Written informed consent 2. German speaking 3. Patients of traumatology and surgery 4. Aged 18 years or older, either sex

Exclusion criteria

Exclusion criteria: 1. Patients who have no wish for shared decision 2. Accommodation in an institution due to an official or judicial order 3. No written consent from patient 4. Unwillingness to allow storage and sharing of anonymised disease data in the context of the clinical study 5. Aged less than 18 years 6. Member of staff of the Charité 7. No working knowledge of German 8. Planned sojourn on intensive care unit

Design outcomes

Primary

MeasureTime frame
1. Analgesia 2. Post-operative nausea and vomiting, using the Visual Analogue Scale (VAS: 0 = no pain/no vomiting, 10 = unbearable pain/extreme vomiting) 3. Post-Anaesthesia Discharge Scoring System (PADSS) PADSS will be measured daily during the patient's study participation in the Charité hospital (longest time until the 5th day of hospital stay).

Secondary

MeasureTime frame
1. World Health Organization (WHO)-5 Well Being Index 2. Patient Involvement in Care Scale 3. Sense of coherence 4. Autonomy Perference Index The patients will be monitored and these parameters will be surveyed every day until they fulfill the hospital discharge criteria (measured by PADSS) up to hospital discharge at fifth of the patient's stay.

Countries

Germany

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026