{
  "study_id": "NCT06632691",
  "agent": "baseline",
  "run": 2,
  "p_primary_hypothesis_supported": 0.5,
  "effect_direction": "favours intervention",
  "effect_size_90pct_interval": {"low": -0.3, "high": 2.2, "metric": "Mean difference in VAS pain, 0-10 (positive = less pain with the headset)"},
  "moderator_prediction": "Anxious patients benefit more: VR hypnosis acts largely through anxiolysis and distraction, and anxious patients have higher procedural pain with more room to fall; sex difference likely small/none.",
  "claim_ids_used": [],
  "rationale": "Unblinded RCT, n=100 (~50/arm), VR hypnosis vs no headset, self-reported VAS immediately after a short procedure: weak comparator and self-report favour a positive result. But the trial was powered on a 2-point gain from a single Chinese colonoscopy trial; rectosigmoidoscopy is less painful (mean VAS perhaps 3-4, SD ~2.5), limiting floor room. Procedural hypnosis meta-analysis gives pain SMD ~0.35; halving the pilot estimate suggests ~1 point (d~0.4), giving roughly 50% power at 50/arm, nudged up for unblinding and expectancy, down for floor effects and small single-centre variance. Net about a coin flip."
}