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Patients who have undergone COVID-19 infection often have long-term sequelae. One of the most prevalent sequelae is pain. The main objective of this research is to investigate the efficacy of a cognitive behavioral principles-based treatment program in fear avoidance beliefs, disability, pain catastrophizing and pain interference.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cognitive behavioral principles-based treatment program group | Experimental |
| |
| Control group | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive behavioral principles-based treatment program | Other | The treatment protocol had a total duration of 6 weeks. Two sessions were conducted each week, the first being a group session lasting 1.5 hours and the second an individual session lasting 45 minutes. During the group sessions, emotional disclosure and sharing of the experiences of patients with post COVID-19 syndrome were encouraged. During the individual sessions, a strong relationship was developed between the patient and the healthcare professional, with the healthcare professional helping the patient develop self-efficacy, thought monitoring, helpful self-talk, and reflection on changes in activity levels throughout the program. |
| Measure | Description | Time Frame |
|---|---|---|
| Fear-avoidance belief changes | Fear avoidance beliefs will be assessed by the the Fear Avoidance Beliefs Questionnaire (FABQ). It consists of 16 sentences related to physical activity (first 5 items) and work (last 11 items). | Baseline |
| Fear-avoidance belief changes | Fear avoidance beliefs will be assessed by the the Fear Avoidance Beliefs Questionnaire (FABQ). It consists of 16 sentences related to physical activity (first 5 items) and work (last 11 items). | At 6 weeks at the end of the intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in functionality | Changes in functionality were measured using the World Health Organization Disability Assessment Schedule, WHODAS-2, which provides a global measure of disability and 7 domain-specific scores. | Baseline |
| Changes in functionality |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marie Carmen Valenza, PhD | Universidad de Granada | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Health Sciences. University of Granada. | Granada | Granada | 18071 | Spain |
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| ID | Term |
|---|---|
| D000094024 | Post-Acute COVID-19 Syndrome |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
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|
| Control intervention | Other | Patients received an informational brochure in a consultation with a health professional. The brochure explained the importance of physical activity to improve the health condition of these patients. Patients had the opportunity to ask any questions to the healthcare professional. |
|
Changes in functionality were measured using the World Health Organization Disability Assessment Schedule, WHODAS-2, which provides a global measure of disability and 7 domain-specific scores. |
| At 6 weeks at the end of the intervention |
| Changes in pain catastrophizing | Changes in pain catastrophizing were assessed with the pain catastrophizing scale. It consists of a 13-item scale with values from 0 to 4. The higher the score, the greater the pain catastrophization. | Baseline |
| Changes in pain catastrophizing | Changes in pain catastrophizing were assessed with the pain catastrophizing scale. It consists of a 13-item scale with values from 0 to 4. The higher the score, the greater the pain catastrophization. | At 6 weeks at the end of the intervention |
| Changes in pain interference | In the PROMIS PI, item category responses range from 1 to 5. T scores had a mean score of 50 and a standard deviation of 10 points. Low scores on the PROMIS PI represent less interference of pain with physical function, whereas high scores represent greater interference with physical function. | Baseline |
| Changes in pain interference | In the PROMIS PI, item category responses range from 1 to 5. T scores had a mean score of 50 and a standard deviation of 10 points. Low scores on the PROMIS PI represent less interference of pain with physical function, whereas high scores represent greater interference with physical function. | At 6 weeks at the end of the intervention |
| Changes in the sensory, affective and evaluative dimensions of pain. | The Short Form McGuill Pain Questionnaire (SF-MPQ) is a version of the original McGuill Pain Questionnaire, discovered by Melzak in 1987. This scale is divided into several parts. The first part consists of a list of 15 adjectives, including 11 sensory and 4 affective descriptors of pain (e.g., terrible, throbbing, etc.) on a scale ranging from 0 (none) to 3 (severe), giving an overall score ranging from 0 to 45, as well as two scores from 0 to 33 for the sensory subscale and 0 to 12 for the affective subscale. In addition, it includes a VAS scale that assesses the patient's pain in the last week. Finally, it includes a Present Pain Intensity Scale (PPI). The PPI is based on a single item measuring overall pain intensity. Patients are asked about their current level of pain on a 5-point Likert scale ranging from 0 (no pain) to 5 (unbearable). This scale has been shown to have excellent psychometric properties. | Baseline |
| Changes in the sensory, affective and evaluative dimensions of pain. | The Short Form McGuill Pain Questionnaire (SF-MPQ) is a version of the original McGuill Pain Questionnaire, discovered by Melzak in 1987. This scale is divided into several parts. The first part consists of a list of 15 adjectives, including 11 sensory and 4 affective descriptors of pain (e.g., terrible, throbbing, etc.) on a scale ranging from 0 (none) to 3 (severe), giving an overall score ranging from 0 to 45, as well as two scores from 0 to 33 for the sensory subscale and 0 to 12 for the affective subscale. In addition, it includes a VAS scale that assesses the patient's pain in the last week. Finally, it includes a Present Pain Intensity Scale (PPI). The PPI is based on a single item measuring overall pain intensity. Patients are asked about their current level of pain on a 5-point Likert scale ranging from 0 (no pain) to 5 (unbearable). This scale has been shown to have excellent psychometric properties. | At 6 weeks at the end of the intervention |
| D007239 |
| Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D000094025 | Post-Infectious Disorders |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |