The SIESTA trial - a randomized Study Investigating the Efficacy, Safety and Tolerability of Acupressure versus sham therapy for improving sleep quality in patients with end-stage kidney disease on haemodialysis

Not Applicable

Completed

• Conditions: Renal and Urogenital - Kidney disease; sleep problem with patients on maintenance haemodialysis; end-stage kidney disease; Alternative and Complementary Medicine - Other alternative and complementary medicine

• Registration Number: ACTRN12615000989549
• Lead Sponsor: David Johnson

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-09-22
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Participants must meet ALL of the following inclusion criteria:
1.On maintenance HD for at least 3 months,
2.3 HD/HDF sessions per week
3.Aged over 18 years
4.No plans to change mode of renal replacement therapy within the study period (4 weeks)
5.Able to provide informed consent
6.Able to complete patient questionnaire in English independently
7.Self-reported history of poor sleep quality

Exclusion Criteria

Participants must not meet ANY of the following exclusion criteria:
1.History of amputation
2.Serious skin problems (e.g. dermatitis) near the location of the acupoints
3.Has background knowledge of Traditional Chinese medicine (TCM)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary objective of the Study is to determine whether the acupressure therapy delivered over 4 weeks during thrice weekly HD/HDF sessions can decrease the Pittsburgh Sleep Quality Index (PSQI) scores. [4 weeks after commencement of intervention]

Secondary Outcome Measures

Name	Time	Method
Patient acceptability assessed using visual analogue scale (VAS) questionnaire<br>[4 weeks after commencement of intervention];Quality of life assessed using (Short Form)-8 Health Survery<br>[4 weeks after commencement of intervention];Side effects (i.e, the local skin reaction from acupressure) will be recorded in Form AE (adverse event).[Any time during the 4 week therapy period]