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| Name | Class |
|---|---|
| Osijek University Hospital | OTHER |
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The primary objective of the study is to determine the effectiveness of nutrition education (individual and group) on the intensity of pain in patients suffering from chronic pain. The secondary goal is to determine whether there is a change in the status of the patient's nutrition, their quality of life, quality of life, and other indicators of the psychophysical condition of the patient.
The underlying hypothesis of the study is that patients with chronic pain that go through a series of nutrition education (individual and group) specifically tailored to fit their needs (based on our preliminary findings), they increase the consumption of foods that have antiinflammatory properties, which will result in lower levels of inflammatory cytokines in the body (high sensitivity C-reactive protein (hs-CRP ), interleukin (IL) -2, IL-4 and IL-6), and consequently reduce the intensity of pain. Also, weight loss in obese patients is expected, and it will have an contributing effect of the intervention. Patient's quality of life and indicators of their psychophysical condition (eg, depression level) are also expected to improve.
Chronic pain patients who either attend Daily clinic (Control Arm) or the 4-week multidisciplinary programme at the Department of Anesthesiology, Resuscitation and Intensive Care (Intervention Arm) will be recruited. They will be followed for total of 8 weeks (4 week intervention + 4 week follow-up).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nutrition Education | Experimental | Participants suffering from chronic pain enrolled in the 4-week Pain Management Clinic organized at the Department of Anesthesiology, Resuscitation and Intensive Care will go through a series of individual and group nutrition educations. Educations are specifically tailored for chronic pain patients, based on our preliminary findings on this group of patients. |
|
| Control | No Intervention | Participants suffering from chronic pain enrolled in the 4-week Pain Management Clinic organized at the Department of Anesthesiology, Resuscitation and Intensive Care. Patients will receive all treatments (e.g. physical therapy) except the nutrition education. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nutrition Education | Other | Every patient will receive one individual and two group counselings on specific nutrition-related recommendations for chronic pain patients. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in pain intensity after the intervention and after 4-week follow-up | We will use simple, patient-based pain screening questionnaire called the painDETECT questionnaire (validated and widely used to assess pain intensity in chronic pain patients). The questionnaire is based on the scale from 1 (no pain) to 10 (extreme pain). | At inclusion, 4 weeks after the intervention, 4 weeks post-intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Change in high-sensitive C-reactive protein after the intervention and after 4-week follow-up | high sensitive C-reactive protein (hs-CRP) (mg/L), | At inclusion, 4 weeks after the intervention, 4 weeks post-intervention |
| Change in interleukines after the intervention and after 4-week follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Change in psychological status after the intervention and after 4-week follow-up | Depression, Anxiety and Stress Scale (DASS-21) Questionnaire is a validate questionnaire freely accessible and will be scored according to the instruction manual. | At inclusion, 4 weeks after the intervention, 4 weeks post-intervention |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ines Banjari, PhD | Department of Food and Nutrition Research, Faculty of Food Technology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Food and Nutrition Research, Faculty of Food Technology | Osijek | 31000 | Croatia |
This project is the doctorate thesis project so all data sharing requests can be submitted after the defense by contacting the PI directly.
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Mar 28, 2023 | |
| Reset | Jan 4, 2024 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Mar 28, 2023 | Jan 4, 2024 |
| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D015596 | Nutrition Assessment |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
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Cluster randomization (groups of patients will be randomly assigned to the Intervention or the Control arm)
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The whole group will be randomized (cluster randomization) to either Intervention or Control arm. Each group consists of 8 to 12 patients.
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|
IL-2 (pg/mL), IL-4 8pg/mL), IL-6 (pg/mL) |
| At inclusion, 4 weeks after the intervention, 4 weeks post-intervention |
| Change in monocyte chemoattractant protein after the intervention and after 4-week follow-up | Monocyte chemoattractant protein (MCP-1) (pg/mL) | At inclusion, 4 weeks after the intervention, 4 weeks post-intervention |
| Change in Health-Related Quality of Life after the intervention and after 4-week follow-up |
The 36-Item Short Form Health Survey (SF-36) is a set of generic, coherent, and easily administered quality-of-life measures. These measures rely upon patient self-reporting and are widely utilized by managed care organizations and by Medicare for routine monitoring and assessment of care outcomes in adult patients. Total of 36 questions (items) are scored on a 0 to 100 range where higher score corresponds to better quality of life. Items are divided into a total of 8 scales and assess the following: physical functioning, role limitations due to physical health, role limitations due to emotional problems, energy/fatigue, emotional well-being, social functioning, pain and general health. For each scale scoring is done on a 0 to 100 range where higher scores correspond to better health. |
| At inclusion, 4 weeks after the intervention, 4 weeks post-intervention |
| Physical activity and sleep monitoring throughout the intervention and follow-up period | Wearable Health (fitness) device (MiFit) will be used to track patient's physical activity and sleep duration. | Throughout the intervention and 4 weeks post-intervention |
| Change in Pain Catastrophizing after the intervention and after 4-week follow-up | The Pain Catastrophizing Scale (PCS) will be used to determine the change in patient's catastrophizing scale related to pain. The questionnaire is based on a scale from 1 (not at all) to 4 (all the time) and assess patient's preoccupation with the pain. The questionnaire will be scored according to the instruction manual. | At inclusion, 4 weeks after the intervention, 4 weeks post-intervention |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D015991 | Epidemiologic Measurements |
| D011634 | Public Health |
| D004778 | Environment and Public Health |