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. 2019 Nov 19;20:631. doi: 10.1186/s13063-019-3773-x

Table 1.

Summary of collected data at each time point according to SPIRIT 2013 guideline

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 × × × × × × × × × × × ×

Abbreviations: BP blood pressure, HD haemodialysis, HR heart rate, S-AMY salivary amylase activity, SPIRIT Standard Protocol Items: Recommendations for Interventional Trials, STAI State-Trait Anxiety Inventory, VAS Visual Analogue Scale