Psychological Assessment in Patients Treated with Spinal Cord Stimulation
NCT ID: NCT06761300
Last Updated: 2025-01-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
50 participants
OBSERVATIONAL
2024-04-09
2026-01-01
Brief Summary
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The primary aim is to study the associations between psychological variables and intervention outcomes (pain reduction, satisfaction, removal of SCS). Our hypothesis is that people with higher scores in anxiety and depression symptoms would report lower satisfaction with SCS procedure and higher levels of perceived pain after the implantation of the device
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Detailed Description
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Patients suffering from CP in charge of the Palliative Care and Pain Therapy Division at the European Institute of Oncology IRCCS (Milan, Italy) will be proposed to undergo SCS surgical implantation to mitigate pain symptoms.
The SCS surgical implantation is a two-step procedure; after the hospital admission, a temporary SCS device will be firstly implanted. In this way patients have the possibility to experiment the device impact on their CP conditions, to familiarize with the external device and adjust to its presence, and to eventually grow their motivation toward the implantation of the permanent device. Only after one month, if the patients are convinced of the intervention utility, the temporary device will be changed with a permanent one.
After the medical consultation, patients accepting the surgical procedure and meeting the inclusion criteria will be invited to participate to the study.
Patients signing the Informed Consent will receive a link to complete a set of questionnaires investigating psychological well-being, the impact of chronic pain in daily activities and the decision-making process to undergo to a surgical procedure. Participants who will not be able to complete the online form, will fill it on paper. Patients will complete different questionnaires at different time-points before and after the two-step SCS implantation.
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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patients with chronic pain
Patients suffering from chronic pain treated with Spinal Cord Stimulation
Psychological assessment
Psychological assessment evaluation at different time points and its correlation with pain outcomes and satisfaction with the SCS intervention.
Interventions
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Psychological assessment
Psychological assessment evaluation at different time points and its correlation with pain outcomes and satisfaction with the SCS intervention.
Eligibility Criteria
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Inclusion Criteria
2. Patient eligible for SCS implantation
3. Age \>18 years old
4. Willingness and ability to comply with scheduled visits and other trial procedures
5. Understanding and speaking Italian language
6. Written informed consent
Exclusion Criteria
2. Comorbidity that may impact on compliance to study procedures
18 Years
ALL
No
Sponsors
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European Institute of Oncology
OTHER
Responsible Party
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Principal Investigators
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Gabriella Pravettoni
Role: PRINCIPAL_INVESTIGATOR
European Institute of Oncology
Locations
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European Institute of Oncology
Milan, Italy, Italy
Countries
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Central Contacts
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Facility Contacts
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Gabriella Pravettoni
Role: backup
Other Identifiers
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IEO 2028
Identifier Type: -
Identifier Source: org_study_id
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