{
  "study_id": "NCT06632691",
  "agent": "baseline",
  "run": 4,
  "p_primary_hypothesis_supported": 0.45,
  "effect_direction": "favours intervention",
  "effect_size_90pct_interval": {"low": -0.3, "high": 2.0, "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 anxiety amplifies procedural pain; no reliable sex difference expected.",
  "claim_ids_used": [],
  "rationale": "Unblinded RCT, n=100 (~50/arm), self-reported procedural pain against a no-headset control, which favours a positive effect. But the trial was powered on a 2-point colonoscopy gain from one Chinese study; halving that and noting rectosigmoidoscopy is shorter and less painful (lower control means, floor effects) suggests ~0.8-1.0 points, SD ~2.5 (d~0.35-0.4). Procedural hypnosis meta-analysis gives pain SMD ~0.35. With 50/arm, power for d~0.35-0.45 is roughly 35-60%. Weak comparator and unblinding lift the chance somewhat. Net probability just under a coin flip."
}
