TIME POINT | Enrolment HD1 | 1 week | 1 week | 1 week | 1 week | ||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|
HD2 | HD3 | HD4 | HD5 | HD6 | HD7 | HD8 | HD9 | HD10 | HD11 | HD12 | HD13 | ||
ENROLMENT | |||||||||||||
 Eligibility screening | × |  |  |  |  |  |  |  |  |  |  |  |  |
 Informed consent | × |  |  |  |  |  |  |  |  |  |  |  |  |
 Allocation | × |  |  |  |  |  |  |  |  |  |  |  |  |
INTERVENTIONS | |||||||||||||
 Early-sequence | |||||||||||||
  No-sound |  | × | × | × |  |  |  | × | × | × |  |  |  |
  Music |  |  |  |  | × | × | × |  |  |  |  |  |  |
  White noise |  |  |  |  |  |  |  |  |  |  | × | × | × |
 Later-sequence | |||||||||||||
  No-sound |  | × | × | × |  |  |  | × | × | × |  |  |  |
  Music |  |  |  |  |  |  |  |  |  |  | × | × | × |
  White noise |  |  |  |  | × | × | × |  |  |  |  |  |  |
ASSESSMENTS | |||||||||||||
 Baseline information | × |  |  |  |  |  |  |  |  |  |  |  |  |
 VAS pain score |  | × | × | × | × | × | × | × | × | × | × | × | × |
 VAS anxiety score |  | × | × | × | × | × | × | × | × | × | × | × | × |
 STAI Y-1 |  |  |  | × |  |  | × |  |  | × |  |  | × |
 STAI Y-2 | × |  |  |  |  |  |  |  |  |  |  |  |  |
 BP and HR |  | × | × | × | × | × | × | × | × | × | × | × | × |
 S-AMY |  |  |  | × |  |  | × |  |  | × |  |  | × |
 Conditional information |  | × | × | × | × | × | × | × | × | × | × | × | × |
 Adverse events |  | × | × | × | × | × | × | × | × | × | × | × | × |