Abdominal Aortic Aneurysm Clinical Trial
— CAMPOfficial title:
Complementary and Alternative Medicine Interventions in Targeting Pain
NCT number | NCT04845334 |
Other study ID # | ASO.Psg.15.01 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | January 2015 |
Est. completion date | June 2017 |
Verified date | July 2021 |
Source | Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This Controlled Randomized Clinical Trial aimed at determining the effectiveness of a modified RR intervention in reducing post-operative pain and psychological symptoms in patients undergoing surgery intervention. Researches hypothesized that compared to controls patients undergoing modified RR intervention were characterized by 1. improved capability to discriminate emotions from bodily feelings; 2. reduce emotional distress; 3. reduced pain perception. Moreover, researches hypothesized that (4) these effects were maintained over time.
Status | Completed |
Enrollment | 128 |
Est. completion date | June 2017 |
Est. primary completion date | June 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - patients waiting for a surgical intervention in the Departments of Vascular Surgery, General Surgery and Neurosurgery; - age = 18 years. Exclusion Criteria: - having a poor knowledge of the Italian language; - having a cognitive impairment; - having a certified psychiatric diagnosis; - having a certified diagnosis of a neurodegenerative disease (i.e., Alzheimer disease, Parkinson disease, etc.) - having been in psychiatric or psychological therapy in the last 6 months |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria | Fondazione CRT, Scuola di Specializzazione in Psicologia Clinica dell'Università degli Studi di Torino |
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* Note: There are 23 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Changes in alexithymia (TAS scores) following a specific short psycho-corporeal intervention | Changes in the Toronto Alexithymia Scale (TAS-20) scores following a specific short psychocorporeal intervention
Total score. Range: 20-100. Higher scores mean a worse outcome. Difficulty in Identifying Feelings (TAS-DIF). Range: 7-35. Higher scores mean a worse outcome. Difficulty in Describing Feelings (TAS-DDF). Range: 5-25. Higher scores mean a worse outcome. Externally Oriented Thinking (TAS-EOT). Range: 8-40. Higher scores mean a worse outcome. |
Baseline; The morning before the surgical intervention; At discharge, assessed up to 10 days; 3 months after the surgical intervention | |
Primary | Changes in anxiety and depression (HADS scores) following a specific short psycho-corporeal intervention | Changes in the Hospital Anxiety and Depression Scale (HADS) scores following a specific short psycho-corporeal intervention.
Anxiety score. Range: 0-21. Higher scores mean a worse outcome. Depression score. Range: 0-21. Higher scores mean a worse outcome. |
[Time Frame: Baseline; The morning before the surgical intervention; At discharge from the hospital, up to 10 days after the intervention; 3 months after the surgical intervention] | |
Primary | Changes in post-traumatic distress (IES-R scores) following a specific short psycho-corporeal intervention | Changes in the Impact of Event Scale - Revised (IES-R) scores following a specific short psycho-corporeal intervention
Total score. Range: 0-88. Higher scores mean a worse outcome. Hyperarousal subscale. Range: 0-4. Higher scores mean a worse outcome. Avoidance subscale. Range: 0-4. Higher scores mean a worse outcome. Intrusion subscale. Range: 0-4. Higher scores mean a worse outcome. |
[Time Frame: Baseline; The morning before the surgical intervention; At discharge from the hospital, up to 10 days after the intervention; 3 months after the surgical intervention] | |
Primary | Changes in pain intensity perception (NRS scores) following a specific short psycho-corporeal intervention | Changes in the Numeric Rating Scale (NRS) scores following a specific short psycho-corporeal intervention
• Total score. Range: 0-10. Higher scores mean a worse outcome. |
[Time Frame: Baseline; The morning before the surgical intervention; At discharge from the hospital, up to 10 days after the intervention; 3 months after the surgical intervention] | |
Primary | Changes in psychological distress (ET scores) following a specific short psycho-corporeal intervention | Changes in the Emotion Thermometer (ET) scores following a specific short psycho-corporeal intervention
Distress scale. Range: 0-10. Higher scores mean a worse outcome. Anxiety scale. Range: 0-10. Higher scores mean a worse outcome. Depression scale. Range: 0-10. Higher scores mean a worse outcome. Anger scale. Range: 0-10. Higher scores mean a worse outcome. Need for help scale. Range: 0-10. Higher scores mean a worse outcome. |
[Time Frame: Baseline; The morning before the surgical intervention; At discharge from the hospital, up to 10 days after the intervention; 3 months after the surgical intervention] | |
Secondary | Effectiveness of the short psycho-corporeal intervention in reducing the use of analgesic drugs. | Effectiveness of the short psycho-corporeal intervention in reducing the use of analgesic drugs | [Time Frame: Baseline; The morning before the surgical intervention; At discharge from the hospital, up to 10 days after the intervention; 3 months after the surgical intervention] |
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