| Protocol ID | NCT06132022 |
| Registration Date | 2023-11-15 |
| Status | completed |
| Sponsor | Bartın Unıversity |
| Country | Turkey (Türkiye) |
| Industry | not industry |
| Blinding | blinded |
| Center Type | singel-center RCT |
| Scope | national RCT |
| First Patient In | 2023-05-31 |
| Last Patient Out | 2024-02-15 |
| Publication | n |
| Gender % | ALL |
| Mean Age | 18 Years - |
NCT06132022
The Effect of Mandala Application on Anxiety Level and Caregiver Burden in Palliative Caregivers: A Randomized Controlled Trial
| Field |
GLM
glm-5.1 11594ms / 8936 tok |
CLAUDE
claude-sonnet-4-20250514 Thinking: claude-opus-4-20250514 4842ms / 10183 tok |
OPENAI
gpt-4o Thinking: o3 3658ms / 8793 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 | OK |
| setting_patient | outpatient | outpatient | outpatient | OK |
| setting_place | other | other | other | OK |
| feasibility | fully powered RCT | fully powered RCT | fully powered RCT | OK |
| intervention_pharmacologic | no | no | no | OK |
| intervention_chemo_immuno_radio | no | no | no | OK |
| intervention_complementary |
yes
yes → no
shaky reasoning✗ No consensus
Initial: yes
Requery: no — The intervention, Mandala coloring, is classified as an art therapy and psychological support tool rather than a complementary and alternative medicine (CAM) modality like acupuncture, yoga, or herbal remedies.
|
yes
yes → yes → no
shaky reasoning✗ No consensus
Initial: yes
Requery: yes — Mandala application involves coloring circular patterns as a non-pharmacological approach for stress reduction and psychological well-being, which falls under complementary and alternative medicine practices.
Thinking: no — Mandala coloring in this context is an art-based activity for stress reduction, not a traditional CAM modality like acupuncture, massage, or herbal remedies.
|
no
no → no → yes
shaky reasoning✗ No consensus
Initial: no
Requery: no — Mandala application is not considered a complementary and alternative medicine (CAM) modality like acupuncture, aromatherapy, or yoga.
Thinking: yes — Mandala coloring is an art-based mind–body complementary therapy akin to meditation practices.
|
|
| intervention_device | no | no | no | OK |
| intervention_psychological |
no
yes → no
shaky reasoning✓ Unanimous
Initial: yes
Requery: no — The intervention is a mandala art/coloring activity, which is an alternative or recreational activity rather than a named or structured psychological therapy like CBT or ACT.
|
no
no → no
shaky reasoning✓ Unanimous
Initial: no
Requery: no — Mandala coloring is an art-based activity rather than a structured psychological therapy like CBT or psychotherapy, and does not constitute a named therapeutic psychological intervention.
|
no
no → no
shaky reasoning✓ Unanimous
Initial: no
Requery: no — Mandala coloring is an art-based activity and does not qualify as a structured psychological therapy like CBT or other named therapies.
|
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 | no | no | no | OK |
| intervention_other |
no
yes → no
shaky reasoning✓ Unanimous
Initial: yes
Requery: no — The mandala coloring intervention is a non-pharmacological approach specifically designed to reduce anxiety, thereby fitting into the psychological category.
|
no
no → yes → no
shaky reasoning✓ Unanimous
Initial: no
Requery: yes — Mandala application (coloring circular patterns) is an art/creative therapy intervention that does not fit into any of the specified categories like pharmacologic, device, psychological therapy, or complementary medicine.
Thinking: no — Mandala coloring is a psychological intervention aimed at reducing anxiety and caregiver burden through art-based therapeutic activity.
|
no
yes → yes → no
shaky reasoning✓ Unanimous
Initial: yes
Requery: yes — Mandala application is an activity-based intervention not fitting the listed categories, such as pharmacologic or device, making it 'intervention_other'.
Thinking: no — The mandala coloring activity is an art-therapy style complementary/psychological intervention, so it falls within the listed categories rather than the residual “other” category.
|
OK |
| 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 | yes | yes | yes | OK |
| pharmacologic_sub | N/A | N/A | N/A | OK |