In the present study, the effect of ear acupressure treatment according to the NADA protocol on the quality of life of patients with advanced tumour diseases. (all stages) will be investigated. Furthermore, the effect of ear acupressure on anxiety and depression, pain, fatigue and sleep of the patients will be assessed.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
125
Within the NADA protocol, 5 defined points on the patient's ears are treated according to a standardized concept (shen men, kidney, lung, liver, vegetative I).
Robert Bosch Krankenhaus
Stuttgart, Germany
RECRUITINGUniversity Hospital Wuerzburg
Würzburg, Germany
RECRUITINGChange in disease-specific quality of life (FACT-MM)
The FACT-MM can depict a more comprehensive picture of the patient's health status and collects data on precisely those areas that are most important to the patient himself. The diagnosis-specific subscale developed in this process assesses pain, fatigue, physical activity, emotional health, and cognitive abilities and represents the primary outcome parameter in this study.
Time frame: after 8 weeks (end of intervention)
Change in anxiety and depressiveness
The four-item PHQ-4 is part of the PHQ-D, a health questionnaire for patients, and is composed of the PHQ-2, a two-item depression scale, and the GAD-2, a two-item anxiety scale.
Time frame: fourth week of intervention
Change in anxiety and depressiveness
The four-item PHQ-4 is part of the PHQ-D, a health questionnaire for patients, and is composed of the PHQ-2, a two-item depression scale, and the GAD-2, a two-item anxiety scale.
Time frame: after 8 weeks (end of intervention)
Change in anxiety and depressiveness
The four-item PHQ-4 is part of the PHQ-D, a health questionnaire for patients, and is composed of the PHQ-2, a two-item depression scale, and the GAD-2, a two-item anxiety scale.
Time frame: 2 weeks post-intervention
Change in anxiety and depressiveness
The four-item PHQ-4 is part of the PHQ-D, a health questionnaire for patients, and is composed of the PHQ-2, a two-item depression scale, and the GAD-2, a two-item anxiety scale.
Time frame: 12 weeks post-intervention
Change of individual symptom burden
Individual symptom burden - patients are asked to rate their 3 most distressing symptoms on a Numerical Rating Scale.
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Time frame: fourth week of intervention
Change of individual symptom burden
Individual symptom burden - patients are asked to rate their 3 most distressing symptoms on a Numerical Rating Scale.
Time frame: after 8 weeks (end of intervention)
Change of pain
Improvement of pain (FACT-MM) questionnaire
Time frame: fourth week of intervention
Change of pain
Improvement of pain (FACT-MM) questionnaire
Time frame: after 8 weeks (end of intervention)
Change of pain
Improvement of pain (FACT-MM) questionnaire
Time frame: 2 weeks post-intervention
Change of pain
Improvement of pain (FACT-MM) questionnaire
Time frame: 12 weeks post-intervention
Change of Fatigue
The Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) is a 13-item questionnaire designed to assess self-reported fatigue and its impact on daily activities and functions.
Time frame: fourth week of intervention
Change of Fatigue
The Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) is a 13-item questionnaire designed to assess self-reported fatigue and its impact on daily activities and functions.
Time frame: after 8 weeks (end of intervention)
Change of Fatigue
The Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) is a 13-item questionnaire designed to assess self-reported fatigue and its impact on daily activities and functions.
Time frame: 2 weeks post-intervention
Change of Fatigue
The Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) is a 13-item questionnaire designed to assess self-reported fatigue and its impact on daily activities and functions.
Time frame: 12 weeks post-intervention
Change of sleep disorders and sleep quality
The Pittsburgh Sleep Quality Index (PSQI) was developed as a standardized self-assessment questionnaire by the University of Pittsburgh to elicit quality of sleep using qualitative and quantitative questions at a 4-week interval
Time frame: fourth week of intervention
Change of sleep disorders and sleep quality
The Pittsburgh Sleep Quality Index (PSQI) was developed as a standardized self-assessment questionnaire by the University of Pittsburgh to elicit quality of sleep using qualitative and quantitative questions at a 4-week interval
Time frame: after 8 weeks (end of intervention)
Change of sleep disorders and sleep quality
The Pittsburgh Sleep Quality Index (PSQI) was developed as a standardized self-assessment questionnaire by the University of Pittsburgh to elicit quality of sleep using qualitative and quantitative questions at a 4-week interval
Time frame: 2 weeks post-intervention
Change of sleep disorders and sleep quality
The Pittsburgh Sleep Quality Index (PSQI) was developed as a standardized self-assessment questionnaire by the University of Pittsburgh to elicit quality of sleep using qualitative and quantitative questions at a 4-week interval
Time frame: 12 weeks post-intervention
Number of pateints with adverse events
Tolerability of the application
Time frame: through study completion, an average of 3 Years