Effects of the Clinical Application of Traditional, Complementary and Integrative Medicine (TCIM) Procedures During Inpatient Stays in Germany

Recruiting

• Conditions: Chronic Disease

• Registration Number: NCT07040475
• Lead Sponsor: Charite University, Berlin, Germany

Brief Summary

The aim of this healthcare research project is to evaluate the effects of routine inpatient TCIM (Traditional, Complementary and Integrative Medicine) care in Germany. The focus is on the TCIM centers at Immanuel Krankenhaus Berlin, Klinikum Bamberg und Evang. Kliniken Essen-Mitte, where inpatient TCIM therapies are to be systematically evaluated. This form of therapy, which is reimbursed by statutory health insurance providers (under certain conditions), is based on a combination of various evidence-based TCIM approaches. These include hyperthermia, exercise therapy, Mind-Body Medicine, phytotherapy, nutritional therapy, fasting therapy inter alia.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-06-11
• Study First Submitted QC: 2025-06-18
• Study First Posted: 2025-06-27
• Status Verified: 2025-07
• Study Start: 2025-07-01
• Last Update Submitted: 2025-07-04
• Last Update Posted: 2025-07-09
• Primary Completion: 2026-12-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2500

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Short Form Health Survey - 12 Items (SF-12)	Baseline, 3 months	0-100, higher scores indicate better health status.

Secondary Outcome Measures

Name	Time	Method
Short Form Health Survey - 12 Items (SF-12)	Baseline, up to 14 days, 6 months, 12 months	0-100, higher scores indicate better health status.
EuroQol 5-Dimension 5-Level	Baseline, up to 14 days, 3 months, 6 months, 12 months	0 (worst) to 1 (best), higher scores indicate better health-related quality of life.
Food Frequency List	Baseline, up to 14 days, 3 months, 6 months, 12 months	Descriptive measure; not scored on a numeric scale.
International Physical Activity Questionnaire - Short Form	Baseline, up to 14 days, 3 months, 6 months, 12 months	MET-min/week (variable), higher scores indicate higher physical activity levels.
Hospital Anxiety and Depression Scale	Baseline, up to 14 days, 3 months, 6 months, 12 months	0-21 per subscale (Anxiety and Depression), higher scores indicate more severe symptoms.
Work Productivity and Activity Impairment Questionnaire	Baseline, 3 months, 6 months, 12 months	0%-100%, higher scores indicate greater impairment (i.e., worse outcome).
Perceived Stress Scale - 4	Baseline, up to 14 days, 3 months, 6 months, 12 months	0-16, higher scores indicate higher perceived stress.
Main complaint	Baseline, up to 14 days, 3 months, 6 months, 12 months	Visual Analog Scale (0-100, higher scores mean a worse outcome)
Fibromyalgia Impact Questionnaire	Baseline, up to 14 days, 3 months, 6 months, 12 months	0-100, higher scores indicate greater impact of fibromyalgia (worse outcome).
Rheumatoid Arthritis Disease Activity Index	Baseline, up to 14 days, 3 months, 6 months, 12 months	0-10, higher scores indicate greater disease activity (worse outcome).
Bath Ankylosing Spondylitis Disease Activity Index	Baseline, up to 14 days, 3 months, 6 months, 12 months	0-10, higher scores indicate more active disease (worse outcome).
Bath Ankylosing Spondylitis Functional Index	Baseline, up to 14 days, 3 months, 6 months, 12 months	0-10, higher scores indicate more functional limitation (worse outcome).
Western Ontario and McMaster Universities Osteoarthritis Index	Baseline, up to 14 days, 3 months, 6 months, 12 months	0-100, higher scores indicate greater pain/stiffness/disability (worse outcome).
Irritable Bowel Syndrome Symptom Severity Score	Baseline, up to 14 days, 3 months, 6 months, 12 months	0-500, higher scores indicate more severe IBS symptoms (worse outcome).
Short Inflammatory Bowel Disease Questionnaire	Baseline, up to 14 days, 3 months, 6 months, 12 months	10-70, higher scores indicate better quality of life.
Pain Disability Index	Baseline, up to 14 days, 3 months, 6 months, 12 months	0-70, higher scores indicate greater disability (worse outcome).
Roland Morris Disability Questionnaire	Baseline, up to 14 days, 3 months, 6 months, 12 months	0-24, higher scores indicate more severe disability (worse outcome).
Maslach Burnout Inventory	Baseline, up to 14 days, 3 months, 6 months, 12 months	Variable by subscale (Emotional Exhaustion: 0-54, Depersonalization: 0-30, Personal Accomplishment: 0-48) Higher scores on EE/DP = worse outcome; higher PA = better outcome.
Beck Depression Inventory-II	Baseline, up to 14 days, 3 months, 6 months, 12 months	0-63, higher scores indicate more severe depressive symptoms (worse outcome).
Diabetes Distress Scale - 17	Baseline, up to 14 days, 3 months, 6 months, 12 months	1-6, higher scores indicate greater emotional distress related to diabetes (worse outcome).
Dermatology Life Quality Index	Baseline, up to 14 days, 3 months, 6 months, 12 months	0-30, higher scores indicate greater impact on quality of life (worse outcome).
Functional Assessment of Cancer Therapy - General	Baseline, up to 14 days, 3 months, 6 months, 12 months	0-108, higher scores indicate better quality of life.
Use of the healthcare system	Baseline,12 months	Descriptive data (e.g., number of visits); not a scored scale.
Expectations regarding inpatient TCIM treatment	Baseline	5-point Likert scale, 1-5. Higher scores indicate stronger or more positive expectations.
Chalder Fatigue Scale	Baseline, up to 14 days, 3 months, 6 months, 12 months	0-33, higher scores mean a worse outcome
Somatic Symptom Scale	Baseline, up to 14 days, 3 months, 6 months, 12 months	0-32, higher scores mean a worse outcome
Body weight [kg]	Baseline, up to 14 days
Height [in cm]	Baseline
BMI [kg/m2]	Baseline, up to 14 days
Systolic blood pressure [mmHg], diastolic blood pressure [mmHg]	Baseline, up to 14 days
Waist circumference [in cm]	Baseline, up to 14 days
Triglycerides [mg/dl]	Baseline, up to 14 days
Total cholesterol [mg/dl]	Baseline, up to 14 days
HDL [mg/dl]	Baseline, up to 14 days
LDL [mg/dl]	Baseline, up to 14 days
Glucose [mg/dl]	Baseline, up to 14 days
Uric acid [μmol/L]	Baseline, up to 14 days
Creatinine [mg/dl]	Baseline, up to 14 days
CRP [mg/l]	Baseline, up to 14 days
GPT [U/l]	Baseline, up to 14 days
HbA1c [mmol/mol]	Baseline, up to 14 days
HbA1c [%]	Baseline, up to 14 days

Trial Locations

Locations (3)

Sozialstiftung Bamberg, Klinikum Bamberg; 🇩🇪 Bamberg, Germany

Charité Hochschulambulanz für Naturheilkunde am Immanuel Krankenhaus, Institut für Sozialmedizin, Epidemiologie und Gesundheitsökonomie, Charité - Universitätsmedizin Berlin; 🇩🇪 Berlin, Germany

Klinik für Naturheilkunde und Integrative Medizin, KEM; 🇩🇪 Essen, Germany