| Protocol ID | NCT05666921 |
| Registration Date | 2022-12-28 |
| Status | recruiting |
| Sponsor | Meyer Children's Hospital IRCCS |
| Country | Italy |
| Industry | not industry |
| Blinding | unblinded |
| Center Type | multicenter RCT |
| Scope | national RCT |
| First Patient In | 2021-06-15 |
| Last Patient Out | 2026-12-01 |
| Publication | n |
| Gender % | ALL |
| Mean Age | 11 Years - 17 Years |
NCT05666921
Somatic Symptoms, Alexithymia and Styles of Attachment: a Cross-sectional Study
| Field |
GLM
glm-5.1 10449ms / 10784 tok |
CLAUDE
claude-sonnet-4-20250514 Thinking: claude-opus-4-20250514 5288ms / 12241 tok |
OPENAI
gpt-4o Thinking: o3 3035ms / 10567 tok |
Review |
|---|---|---|---|---|
| rct_type | N/A | N/A | N/A | OK |
| cancer_status | non-cancer | non-cancer | non-cancer | OK |
| non_cancer_spec | N/A | N/A | N/A | OK |
| setting_patient | outpatient | outpatient | outpatient | OK |
| setting_place |
other
hospital → other
shaky reasoning✓ Unanimous
Initial: hospital
Requery: other — The intervention (psychological assessment) is delivered to patients during an outpatient psychological consult or clinic visit at a hospital, not during an inpatient admission.
|
other
other → other
shaky reasoning✓ Unanimous
Initial: other
Requery: other — This is an observational study where pediatric patients and control group participants complete psychological assessments and questionnaires during outpatient psychological consultations at hospital clinics, not requiring hospitalization or admission.
|
other
other → other
shaky reasoning✓ Unanimous
Initial: other
Requery: other — The intervention consists of psychological assessments conducted during outpatient psychological consultations without specific mention of being conducted in a hospital inpatient setting or any other defined setting.
|
OK |
| feasibility | N/A | N/A | N/A | OK |
| intervention_pharmacologic | no | no | no | OK |
| intervention_chemo_immuno_radio | no | no | no | OK |
| intervention_complementary | no | no | no | OK |
| intervention_device | no | no | no | OK |
| intervention_psychological |
no
no → no
shaky reasoning✓ Unanimous
Initial: no
Requery: no — The study is an observational cross-sectional study involving only psychological assessments and questionnaires, without any structured therapeutic intervention.
|
no
yes → no
shaky reasoning✓ Unanimous
Initial: yes
Requery: no — This is an observational study conducting psychological assessments using various tests and questionnaires to measure psychological aspects, not implementing any structured psychological therapy intervention.
|
no
yes → no
shaky reasoning✓ Unanimous
Initial: yes
Requery: no — The study involves psychological assessment, not a structured psychological therapy or approach.
|
OK |
| intervention_complex | no | no | no | OK |
| intervention_acp | no | no | no | OK |
| intervention_music | no | no | no | OK |
| intervention_screening |
no
no → no
shaky reasoning✓ Unanimous
Initial: no
Requery: no — This observational study uses psychological assessments and questionnaires as outcome measures to evaluate correlations between variables, not to test a screening intervention.
|
no
yes → no
shaky reasoning✓ Unanimous
Initial: yes
Requery: no — This is an observational cross-sectional study that uses psychological assessment tools to evaluate relationships between emotional awareness, attachment style, and somatic symptoms, rather than testing a screening intervention.
|
no
no → no
shaky reasoning✓ Unanimous
Initial: no
Requery: no — The study involves psychological assessments using various tests, but these assessments are not the intervention being experimentally tested; rather, they are tools to measure psychological and emotional factors.
|
OK |
| intervention_palliative | no | no | no | OK |
| intervention_education | no | no | no | OK |
| intervention_digital | no | no | no | OK |
| intervention_other |
no
yes → no
shaky reasoning✓ Unanimous
Initial: yes
Requery: no — The intervention consists of psychological assessments (including questionnaires and tests to measure emotional awareness, attachment style, and reflective functioning), which categorizes it as a psychological intervention.
|
no
no → no → no
shaky reasoning✓ Unanimous
Initial: no
Requery: no — This is an observational study with only psychological assessment involving standardized questionnaires and tests, which fits the psychological intervention category.
Thinking: no — This is a psychological intervention involving psychological assessment and consultation with various psychological tests and questionnaires.
|
no
no → yes → no
shaky reasoning✓ Unanimous
Initial: no
Requery: yes — The intervention is a psychological assessment, which does not fit into the specified categories and is primarily observational, focusing on evaluating psychological aspects rather than providing a treatment or educational intervention.
Thinking: no — The study’s only intervention is a psychological assessment/testing battery, which falls under the predefined psychological category.
|
OK |
| outcome_symptom | yes | yes | yes | OK |
| outcome_qol |
no
yes
shaky reasoning✓ Unanimous
Initial: yes
|
no
no → no
shaky reasoning✓ Unanimous
Initial: no
Requery: no — This study focuses on psychological assessments (emotional awareness, attachment style, IQ) and symptom measures (pain scales) but does not include any validated quality of life instruments like EORTC QLQ-C30, FACT-G, EQ-5D, SF-36, or WHOQOL.
|
no
yes → no
shaky reasoning✓ Unanimous
Initial: yes
Requery: no — The clinical trial does not use any validated Quality of Life instruments listed, but focuses on assessing emotional awareness, attachment style, and related psychological aspects.
|
OK |
| outcome_dignity | no | no | no | OK |
| outcome_cost |
yes
yes → yes
shaky reasoning✓ Unanimous
Initial: yes
Requery: yes — The study explicitly states that one of its objectives is 'to quantify the health costs incurred in the diagnostic phase prior to the classification of the somatic symptom'.
|
yes
no → yes → yes
shaky reasoning✓ Unanimous
Initial: no
Requery: yes — The study explicitly aims to quantify health costs incurred in the diagnostic phase prior to classification of somatic symptoms as stated in the detailed description.
Thinking: yes — The study explicitly aims to quantify the health costs incurred in the diagnostic phase prior to the classification of the somatic symptom.
|
yes
yes → no → yes
shaky reasoning✓ Unanimous
Initial: yes
Requery: no — The trial focuses on somatic symptoms, emotional awareness, attachment styles, and psychological assessments without a direct cost framing or economic evaluation.
Thinking: yes — Study explicitly aims to quantify healthcare costs incurred in the diagnostic phase.
|
OK |
| outcome_other | yes | yes | yes | OK |
| pharmacologic_sub | N/A | N/A | N/A | OK |