| Protocol ID | NCT05861934 |
| Registration Date | 2023-05-17 |
| Status | completed |
| Sponsor | Aksaray University Training and Research Hospital |
| Country | Turkey (Türkiye) |
| Industry | not industry |
| Blinding | blinded |
| Center Type | multicenter RCT |
| Scope | national RCT |
| First Patient In | 2022-11-20 |
| Last Patient Out | 2024-07-20 |
| Publication | n |
| Gender % | ALL |
| Mean Age | 18 Years - 90 Years |
NCT05861934
The Effect of Distant Reiki Application on Pain, Functional Status and Sleep Quality in Rheumatoid Arthritis Patients
| Field |
GLM
glm-5.1 5982ms / 8637 tok |
CLAUDE
claude-sonnet-4-20250514 Thinking: claude-opus-4-20250514 5034ms / 9859 tok |
OPENAI
gpt-4o Thinking: o3 3138ms / 8470 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 | outpatient | outpatient | outpatient | OK |
| setting_place | other | other | other | OK |
| feasibility |
fully powered RCT
feasibility RCT → feasibility RCT
shaky reasoning✓ Unanimous
Initial: feasibility RCT
Requery: feasibility RCT — The study has a small enrollment of 45 participants (n≤30 threshold applies given crossover design and lack of sample size justification) and focuses on clinical outcomes without explicit sample size calculation or pilot/feasibility labeling.
|
fully powered RCT
fully powered RCT → fully powered RCT → fully powered RCT
shaky reasoning✓ Unanimous
Initial: fully powered RCT
Requery: fully powered RCT — This is a crossover RCT with n=45 testing clinical effectiveness outcomes (pain, functional status, sleep quality) without any mention of pilot/feasibility objectives or recruitment/retention as primary outcomes.
Thinking: fully powered RCT — Primary outcomes are clinical effectiveness measures (pain, functional status, sleep quality) with n=45 participants, not feasibility/acceptability outcomes.
|
fully powered RCT
fully powered RCT → feasibility RCT → fully powered RCT
shaky reasoning✓ Unanimous
Initial: fully powered RCT
Requery: feasibility RCT — The primary outcomes focus on pain, functional status, and sleep quality rather than recruitment; however, the enrollment of 45 suggests it is not fully powered, likely serving as a pilot study.
Thinking: fully powered RCT — Randomized trial with clinical outcomes (pain, function, sleep) and no mention of pilot/feasibility aims or recruitment metrics
|
OK |
| intervention_pharmacologic | no | no | no | OK |
| intervention_chemo_immuno_radio | no | no | no | OK |
| intervention_complementary | yes | yes | yes | OK |
| intervention_device | no | no | no | 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 | no | no | no | OK |
| intervention_other | no | no | no | 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 |
no
yes → no
shaky reasoning✓ Unanimous
Initial: yes
Requery: no — All outcomes (pain, functional status, and sleep quality) are symptom-related measures.
|
no
yes → no
shaky reasoning✓ Unanimous
Initial: yes
Requery: no — All primary outcomes (pain level, functional status, and sleep quality) fall within the symptom/QoL categories for palliative care research.
|
no
no → no
shaky reasoning✓ Unanimous
Initial: no
Requery: no — The outcomes - pain, functional status, and sleep quality - are all related to symptoms and quality of life for rheumatoid arthritis patients.
|
OK |
| pharmacologic_sub | N/A | N/A | N/A | OK |