Table 1.
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