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Socio-medical aftercare for severely chronified pediatric pain patients: A randomized controlled multicenter study

Socio-medical aftercare for severely chronified pediatric pain patients: A randomized controlled multicenter study - SCHMERZ-NETZ

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00015230
Enrollment
394
Registered
2018-08-06
Start date
2018-09-01
Completion date
Unknown
Last updated
2025-04-07

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

Conditions

F45.4

Interventions

Group 1: Pediatric pain patients with usual aftercare after discharge from inpatient treatment(TAU). Group 2: Pediatric pain patients with social-medical aftercare after discharge from inpatient treat

Sponsors

Universität Witten/Herdecke
Lead Sponsor

Eligibility

Sex/Gender
All
Age
8 Years to 17 Years

Inclusion criteria

Inclusion criteria: 1. Complex persistent pain. 2. An age-appropriate German language and reading comprehension to answer the questionnaires 3. Initial admission to pain ward during the study period 4. Consent for the participation of the parent and the patient

Exclusion criteria

Exclusion criteria: No consent to participate

Design outcomes

Primary

MeasureTime frame
Chronic pain grading: It is assumed that the patients in the SMN group show a lower pain severity 6 months after discharge, i.e. show lower CPG levels than the control group. (Note: Compared to the 1st version of the study document, the primary endpoint has been shifted from 12-month follow-up to 6-month follow-up. This adjustment was necessary due to the corona pandemic, since the data collection for the 12-month follow-up (March 2020 to December 2020) falls within the period of corona pandemic-related school closures and therefore the parameter "pain-related school absence" used in the CPG calculation cannot be validly captured.) Furthermore, the primary endpoint was extended by the "presence of at least weekly pain" at the 12-month follow-up.

Secondary

MeasureTime frame
Secondary endpoints: The following hypotheses are formulated for the secondary endpoints: • Pain characteristics: At all follow-ups, children and adolescents in the intervention group SMN pain show a greater reduction in pain intensity, pain-related impairment in everyday life and pain-related school days as patients of the control group. • Emotional impairment: At all follow-ups, children and adolescents in the intervention group show a greater reduction of anxiety and depression and a greater increase in the quality of life than patients in the control group. • Therapy adherence: Children and adolescents in the intervention group have implemented therapy recommendations more frequently at all follow-ups than patients in the control group. • Therapy satisfaction: Children and adolescents in the intervention group show greater treatment satisfaction at all follow-ups than patients in the control group. • Use of health services: in the year after inpatient treatment, patients in the intervention group are more likely to take advantage of the health benefits recommended when dismissed than patients in the control group. • Routine data: In the year following the inpatient treatment, both patient groups cause comparable costs. In subsequent years, the costs incurred by the intervention group are below those of the control group. • Effects of the corona pandemic: At the 12-month follow-up, children and adolescents in the intervention group show a lower emotional burden resulting from the corona pandemic than patients in the control group; additional exploratory analyses planned • Experiences of the patients and their families with SMN

Countries

Germany

Contacts

Public ContactMeltem Dogan

Vestische Kinder- und JugendklinikUniversität Witten/HerdeckeDeutsches Kinderschmerzzentrum

m.dogan@deutsches-kinderschmerzzentrum.de0049-2363-975-8062

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 14, 2026