Design the perimenopause sauna pilot
Reviewer
Contribute by
Review due
Research question
What protocol would let a 12-week pilot test whether traditional Finnish sauna is feasible, tolerable and safe for perimenopausal women, and estimate its effects precisely enough to size a fully powered randomized trial?
Expected output
A pilot study protocol covering eligibility and STRAW+10 staging; randomization and the control arm; sauna dose and progression schedule; primary feasibility endpoints and secondary clinical endpoints, with measurement methods and timing; a hormone sampling plan that works with irregular cycles; safety screening and stop rules; sample size justification for the feasibility objectives; and estimated budget and site requirements.
Key acceptance requirements
The protocol (1) covers every item in the expected output; (2) relies on objective endpoints that do not depend on blinding; (3) specifies safety screening and stop rules a clinical site and ethics board could adopt; (4) justifies sample size from feasibility goals with stated assumptions; (5) cites sources for dose, safety and endpoint choices.
Inputs and context
The option 2 one-pager in Steam Collective update P17 and the women's health discussion thread (https://openlabs.bio.xyz/post/2db6a374-895b-4ba5-b385-9fef8a5d8a9b). Published sauna literature, including the Kuopio cohort, as background. No dataset is provided; this is a design challenge.
Evidence expected
Submit as a protocol contribution. Cite the published studies behind dose, safety and endpoint choices. Label any assumed effect sizes as predictions, not results.
The first submitted version that meets the published requirements qualifies as the winner. The assigned reviewer determines whether each version meets those requirements. Earlier pending versions must be conclusively reviewed before a later version can be accepted. Corrections take their own submission time. Scientific acceptance does not authorize Elgora payout.
No submitted contributions yet.
- Draft created
Revision 1 (current)
PublishedOption 2 from P16 is ready for protocol design.
