Randomized control trial for effectiveness of Zolpidem versus acupressure on sleep in hemodialysis patients having chronic kidney disease (CKD) associated pruritus

Not Applicable

Completed

• Conditions: Sleep quality; CKD associated pruritus; Chronic Kidney disease; hemodialysis; Renal and Urogenital - Kidney disease

• Registration Number: ACTRN12618000001291
• Lead Sponsor: Monash University Malaysia

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-01-08
• Study Completion: 2018-05-31
• Last Update Posted: 15 July 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 58

Inclusion Criteria

Participants for this RCT must be Adult patients (above age of 18 years), diagnosed with end-stage kidney disease; having CKD associated pruritus affecting sleep quality; and receiving dialysis twice or thrice weekly.

Exclusion Criteria

Participants not having CKD associated pruritus, PSQI score less than 5, using any treatment to improve sleep, no willing to participate.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sleep quality assessed by Pittsburgh Sleep Quality Index (PSQI) scores among patients having chronic kidney disease associated pruritus[At baseline (0 week) , 4 weeks and 8 weeks (primary time point).]

Secondary Outcome Measures

Name	Time	Method
Patient acceptability to be assessed by Treatment Acceptability Questionnaire (TAQ).<br>[At baseline (0 week) , 4 weeks and 8 weeks (time point).];Quality of life (EQ5D-3L) will be measured.[At 6th weeks and 8th weeks (time point).];Adverse events will be monitored by Naranjo’s algorithm known to be a valid measure for reporting and authenticating drug-related events. [At 6th weeks and 8th weeks (time point).]