The study aims to identify whether a multimodal integrative naturopathy outpatient clinical concept can improve the symptoms of patients suffering from post-COVID-Syndrome. Main outcome is fatigue. The outpatient clinical programme consists of 11 weeks wherein patients visit the clinic one day per week. The pillars of classical naturopathy are combined with extended naturopathy and complementary procedures. Previous naturopathical studies on patients with chronic fatigue syndrome could find numerous indications that different types of naturopathy can help patients with fatigue.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
42
Patients receive multimodal integrative medicine and naturopathy applications with focus on mind-body-medicine and whole body hyperthermia to reduce fatigue and improve quality of life.
Patients receive no intervention
Sozialstiftung Bamberg, Klinik für Intergrative Medizin
Bamberg, Bavaria, Germany
Fatigue - Change from week 0 to week 11
measured with MFI-20 questionnaire and Chalder fatigue scale MFI-20: 20-item self-report instrument designed to measure fatigue. It covers the following dimensions: General Fatigue, Physical Fatigue, Mental Fatigue, Reduced Motivation and Reduced Activity. Higher total scores correspond with more acute levels of fatigue. Chalder fatigue scale: a questionnaire to measure the severity of tiredness in fatiguing illnesses. The 11-item chalder fatigue scale is often divided into two components: one that measures physical fatigue (questions 1-7) and one that measures mental fatigue (questions 8-11).
Time frame: before start of intervention (week 0) and afterwards (week 11)
Quality of life 1
SF-12: Short Form of the Health Survey Questionnaire is a 12-item, patient-reported survey of patient health. It is a reduced size version of the SF-36, and is widely used.
Time frame: before start of intervention (week 0) and afterwards (week 11)
Hospital Anxiety and Depression
HADS: Hospital Anxiety and Depression Scale, 14 items (7 each for depressive symptoms or symptoms of anxiety). The two summated scores of the summated scales HADS-A and HADS-D range between 0 and 21. High scores indicate depressivness and anxiety.
Time frame: before start of intervention (week 0) and afterwards (week 11)
Perceived Stress
PSS-10: Perceived Stress Scale, Rating on a five-step scale from 1 (= never) to 5 (=very often), high stress is assumed from a total score of 20 points
Time frame: before start of intervention (week 0) and afterwards (week 11)
perceived Pain
BPI: Brief Pain Inventory, An inventory including 15 Items about the intensity of pain (4 items, numeric rating scales from 1 (no pain) to 10 (worst pain imaginable), pain impairment (7 items with NRS from 1-10) and the efficacy of medications/treatments. Higher scores indicate higher average pain/pain impairment.
Time frame: before start of intervention (week 0) and afterwards (week 11)
Quality of life 2
EQ-5D: Quality of life EQ-5D is an instrument which evaluates the generic quality of life. The EQ-5D descriptive system is a preference-based HRQL measure with one question for each of the five dimensions that include mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.
Time frame: before start of intervention (week 0) and afterwards (week 11)
Sleep Quality
PSQI: Der Pittsburgh Sleep Quality Index It contains seven subscales: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. All items refer to the last four weeks and are assessed either in four frequency levels or in an open-end format. A total sum score from 0 - 21 can be derived from the subscales with higher scores indicating higher sleep disturbance.
Time frame: before start of intervention (week 0) and afterwards (week 11)
Resilience
BRS: Brief Resilience Scale Questionnaire A 6-item questionnaire to assess the perceived ability to bounce back or recover from stress. The possible score range on the BRS is from 1 (low resilience) to 5 (high resilience).
Time frame: before start of intervention (week 0) and afterwards (week 11)
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