| Protocol ID | NCT06156540 |
| Registration Date | 2023-12-05 |
| Status | completed |
| Sponsor | Necmettin Erbakan University |
| Country | Turkey (Türkiye) |
| Industry | not industry |
| Blinding | blinded |
| Center Type | singel-center RCT |
| Scope | national RCT |
| First Patient In | 2023-06-15 |
| Last Patient Out | 2023-10-15 |
| Publication | n |
| Gender % | ALL |
| Mean Age | – |
NCT06156540
The Effect of Virtual Reality Glasses on the Psychological Well-Being and Care Burden of Patient Relatives Giving Care to Patients in the Palliative Care Clinic
| Field |
GLM
glm-5.1 6523ms / 8942 tok |
CLAUDE
claude-sonnet-4-20250514 Thinking: claude-opus-4-20250514 5282ms / 10191 tok |
OPENAI
gpt-4o Thinking: o3 3555ms / 8803 tok |
Review |
|---|---|---|---|---|
| rct_type | parallel RCT | parallel RCT | parallel RCT | OK |
| cancer_status | non-cancer | non-cancer | non-cancer | OK |
| non_cancer_spec |
N/A
N/A → N/A
shaky reasoning✓ Unanimous
Initial: N/A
Requery: N/A — The trial focuses on caregivers of a general, undifferentiated palliative care population without specifying any particular non-cancer disease or the timing of palliative care integration.
|
N/A
early palliative care → N/A
shaky reasoning✓ Unanimous
Initial: early palliative care
Requery: N/A — The study focuses on caregivers of patients in palliative care clinics with mixed/unspecified underlying conditions, making it too general to classify into a specific non-cancer category.
|
N/A
N/A → N/A
shaky reasoning✓ Unanimous
Initial: N/A
Requery: N/A — The study focuses on the psychological well-being and care burden of caregivers in a palliative care clinic without specifying a particular non-cancer diagnosis focus.
|
OK |
| setting_patient | inpatient | inpatient | inpatient | OK |
| setting_place | hospital | hospital | hospital | OK |
| feasibility |
fully powered RCT
feasibility RCT → feasibility RCT
shaky reasoning✓ Unanimous
Initial: feasibility RCT
Requery: feasibility RCT — The study has a small sample size of 44 participants, which is below the threshold for a fully powered clinical effectiveness trial, and it assesses clinical outcomes such as psychological well-being and care burden.
|
fully powered RCT
fully powered RCT → fully powered RCT → fully powered RCT
shaky reasoning✓ Unanimous
Initial: fully powered RCT
Requery: fully powered RCT — This appears to be a fully powered RCT with 44 participants (n=22 per group) designed to evaluate clinical effectiveness of virtual reality intervention on psychological well-being and care burden, with proper sample size and clinical outcomes.
Thinking: fully powered RCT — Primary outcomes are clinical (psychological well-being) not feasibility measures, and enrollment of 44 participants suggests adequate power for clinical outcomes.
|
fully powered RCT
feasibility RCT → feasibility RCT → fully powered RCT
shaky reasoning✓ Unanimous
Initial: feasibility RCT
Requery: feasibility RCT — The study has a small sample size (n=44) and focuses on assessing acceptability and effectiveness of an intervention, which indicates it is a pilot/feasibility RCT.
Thinking: fully powered RCT — Randomized trial targeting clinical effectiveness outcomes with n=44 and no mention of feasibility or recruitment metrics
|
OK |
| intervention_pharmacologic | no | no | no | OK |
| intervention_chemo_immuno_radio | no | no | no | OK |
| intervention_complementary | no | no | no | OK |
| intervention_device | yes | yes | yes | OK |
| intervention_psychological | no | no | no | OK |
| intervention_complex | no | no | no | OK |
| intervention_acp | no | no | no | OK |
| intervention_music | no | no | no | OK |
| intervention_screening | no | no | no | OK |
| intervention_palliative | no | no | no | OK |
| intervention_education | no | no | no | OK |
| intervention_digital | yes | yes | yes | OK |
| intervention_other | no | no | no | OK |
| outcome_symptom | no | no | no | OK |
| outcome_qol | no | no | no | OK |
| outcome_dignity |
no
no
shaky reasoning✓ Unanimous
Initial: no
|
no
no → no
shaky reasoning✓ Unanimous
Initial: no
Requery: no — The study measures general psychological well-being and caregiver burden, not existential/spiritual themes like dignity, meaning in life, or spiritual distress.
|
no
yes → no
shaky reasoning✓ Unanimous
Initial: yes
Requery: no — The trial measures psychological well-being and care burden without explicitly addressing existential or spiritual themes.
|
OK |
| outcome_cost | no | no | no | OK |
| outcome_other | yes | yes | yes | OK |
| pharmacologic_sub | N/A | N/A | N/A | OK |