NCT05666921

Somatic Symptoms, Alexithymia and Styles of Attachment: a Cross-sectional Study

Extracted Fields (from Registry)
Protocol IDNCT05666921
Registration Date2022-12-28
Statusrecruiting
SponsorMeyer Children's Hospital IRCCS
CountryItaly
Industrynot industry
Blindingunblinded
Center Typemulticenter RCT
Scopenational RCT
First Patient In2021-06-15
Last Patient Out2026-12-01
Publicationn
Gender %ALL
Mean Age11 Years - 17 Years
LLM Classifications (Side-by-Side)
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
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