| Protocol ID | NCT06121440 |
| Registration Date | 2023-11-08 |
| Status | completed |
| Sponsor | Gamze Akay |
| Country | Turkey (Türkiye) |
| Industry | not industry |
| Blinding | blinded |
| Center Type | singel-center RCT |
| Scope | national RCT |
| First Patient In | 2023-11-13 |
| Last Patient Out | 2023-12-08 |
| Publication | n |
| Gender % | ALL |
| Mean Age | 6 Months - 18 Years |
NCT06121440
The Effect of Musical-Animated Toys and Audio Books on Fear, and Pain in the Tracheostomy Care of Children in the Palliative Care
| Field |
CLAUDE
claude-sonnet-4-20250514 4784ms / 10114 tok |
GLM
glm-5.1 8648ms / 8895 tok |
OPENAI
gpt-4o Thinking: o3 2873ms / 8741 tok |
Review |
|---|---|---|---|---|
| rct_type | cross-over RCT | cross-over RCT | cross-over RCT | OK |
| cancer_status | non-cancer | non-cancer | non-cancer | OK |
| non_cancer_spec | N/A | N/A | N/A | OK |
| setting_patient | inpatient | inpatient | inpatient | OK |
| setting_place | hospital | hospital | hospital | OK |
| feasibility | feasibility RCT | feasibility RCT | feasibility RCT | 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 | OK |
| intervention_complex | no |
no
no → no
shaky reasoning✓ Unanimous
Initial: no
Requery: no — The study compares two single-modality psychological/behavioral interventions (audiobook vs. musical toy) used as distraction techniques during procedures, rather than combining them into a multi-component complex intervention.
|
no
yes → no
shaky reasoning✓ Unanimous
Initial: yes
Requery: no — The intervention involves two single components (audiobook and musical toy) tested separately, not combined as a multi-component intervention from different categories.
|
OK |
| intervention_acp | no | no | no | OK |
| intervention_music | yes | yes | yes | OK |
| intervention_screening | no | no | no | OK |
| intervention_palliative | no |
no
no
shaky reasoning✓ Unanimous
Initial: no
|
no
yes → no
shaky reasoning✓ Unanimous
Initial: yes
Requery: no — The intervention involves musical toys and audiobooks, not palliative care consultation or delivery.
|
OK |
| intervention_education | no | no | no | OK |
| intervention_digital | no |
no
no
shaky reasoning✗ No consensus
Initial: no
|
yes
yes → yes → yes
shaky reasoning✗ No consensus
Initial: yes
Requery: yes — The audiobook is delivered via tablet computers, making digital technology a primary delivery mechanism for the intervention.
Thinking: yes — The intervention relies on playing an audiobook to children via a tablet computer, making digital technology the primary means of delivering the therapeutic content.
|
|
| intervention_other | yes | no | no | – |
| outcome_symptom | yes | yes | yes | OK |
| outcome_qol | no | no | no | OK |
| outcome_dignity | no | no | no | OK |
| outcome_cost | no | no | no | OK |
| outcome_other | no |
no
yes → no
shaky reasoning✓ Unanimous
Initial: yes
Requery: no — All outcomes (pain, anxiety, fear, and vital signs) are symptom-related measurements.
|
no
no → no
shaky reasoning✓ Unanimous
Initial: no
Requery: no — All outcomes focus on measuring pain, anxiety, and fear, fitting within symptom categories.
|
OK |
| pharmacologic_sub | N/A | N/A | N/A | OK |