{
"info": {
"nct_id": "NCT05708872",
"official_title": "The Effect of Methods of Self-regulation of Mental State on Pain Perception in the Postoperative Period in Colon Cancer Patients",
"inclusion_criteria": "1. Written informed consent to participate in the study\n2. Age >= 18 years\n3. Histopathological diagnosis of primary colon cancer without distant metastasis\n4. Planned surgical treatment\n5. Fluency in Polish\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
"exclusion_criteria": "1. Severe comorbidities with pain disorders\n2. Regular use of analgesics\n3. Coexistence of another neoplastic disease\n4. Use of non-pharmacological pain management (including autohypnosis) prior to the study\n5. Poor general condition\n6. Previous colorectal surgery\n7. Hearing disorders\n8. No possibility of playback of the received recording",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"line": "1. Written informed consent to participate in the study",
"criterions": [
{
"exact_snippets": "Written informed consent to participate in the study",
"criterion": "informed consent",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "2. Age >= 18 years",
"criterions": [
{
"exact_snippets": "Age >= 18 years",
"criterion": "age",
"requirements": [
{
"requirement_type": "N/A",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "years"
}
}
]
}
]
},
{
"line": "3. Histopathological diagnosis of primary colon cancer without distant metastasis",
"criterions": [
{
"exact_snippets": "Histopathological diagnosis of primary colon cancer",
"criterion": "primary colon cancer",
"requirements": [
{
"requirement_type": "diagnosis",
"expected_value": "histopathological"
}
]
},
{
"exact_snippets": "without distant metastasis",
"criterion": "distant metastasis",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
}
]
},
{
"line": "4. Planned surgical treatment",
"criterions": [
{
"exact_snippets": "Planned surgical treatment",
"criterion": "surgical treatment",
"requirements": [
{
"requirement_type": "planned",
"expected_value": true
}
]
}
]
},
{
"line": "5. Fluency in Polish",
"criterions": [
{
"exact_snippets": "Fluency in Polish",
"criterion": "fluency in Polish",
"requirements": [
{
"requirement_type": "proficiency",
"expected_value": "fluent"
}
]
}
]
},
{
"line": "Healthy volunteers allowed",
"criterions": [
{
"exact_snippets": "Healthy volunteers allowed",
"criterion": "volunteer health status",
"requirements": [
{
"requirement_type": "status",
"expected_value": "healthy"
}
]
}
]
},
{
"line": "Must have minimum age of 18 Years",
"criterions": [
{
"exact_snippets": "minimum age of 18 Years",
"criterion": "age",
"requirements": [
{
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "Years"
}
}
]
}
]
}
],
"exclusion_lines": [
{
"line": "1. Severe comorbidities with pain disorders",
"criterions": [
{
"exact_snippets": "Severe comorbidities",
"criterion": "comorbidities",
"requirements": [
{
"requirement_type": "severity",
"expected_value": "severe"
}
]
},
{
"exact_snippets": "pain disorders",
"criterion": "pain disorders",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "2. Regular use of analgesics",
"criterions": [
{
"exact_snippets": "Regular use of analgesics",
"criterion": "analgesics use",
"requirements": [
{
"requirement_type": "frequency",
"expected_value": "regular"
}
]
}
]
},
{
"line": "3. Coexistence of another neoplastic disease",
"criterions": [
{
"exact_snippets": "Coexistence of another neoplastic disease",
"criterion": "neoplastic disease",
"requirements": [
{
"requirement_type": "coexistence",
"expected_value": true
}
]
}
]
},
{
"line": "5. Poor general condition",
"criterions": [
{
"exact_snippets": "Poor general condition",
"criterion": "general condition",
"requirements": [
{
"requirement_type": "quality",
"expected_value": "poor"
}
]
}
]
},
{
"line": "6. Previous colorectal surgery",
"criterions": [
{
"exact_snippets": "Previous colorectal surgery",
"criterion": "colorectal surgery",
"requirements": [
{
"requirement_type": "history",
"expected_value": true
}
]
}
]
},
{
"line": "7. Hearing disorders",
"criterions": [
{
"exact_snippets": "Hearing disorders",
"criterion": "hearing disorders",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "8. No possibility of playback of the received recording",
"criterions": [
{
"exact_snippets": "No possibility of playback of the received recording",
"criterion": "playback of the received recording",
"requirements": [
{
"requirement_type": "possibility",
"expected_value": false
}
]
}
]
}
],
"miscellaneous_lines": [],
"failed_inclusion": [],
"failed_exclusion": [
{
"line": "4. Use of non-pharmacological pain management (including autohypnosis) prior to the study",
"criterions": [
{
"exact_snippets": "Use of non-pharmacological pain management (including autohypnosis) prior to the study",
"criterion": "non-pharmacological pain management",
"requirements": [
{
"requirement_type": "use",
"expected_value": true
}
]
},
{
"exact_snippets": "Use of ... autohypnosis prior to the study",
"criterion": "autohypnosis",
"requirements": [
{
"requirement_type": "use",
"expected_value": true
}
]
}
]
}
],
"failed_miscellaneous": []
}