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

• Register: ANZCTR
• Last refreshed on: 15 July 2019
• Main ID: ACTRN12618000001291
• Date of registration: 08/01/2018
• Prospective Registration: Yes
• Primary sponsor: Monash University Malaysia
• Public title: Randomized control trial for effectiveness of Zolpidem versus acupressure on sleep in hemodialysis patients having chronic kidney disease (CKD) associated pruritus
• Scientific title: Randomized control trial for effectiveness of Zolpidem versus acupressure on sleep quality in hemodialysis patients having chronic kidney disease (CKD) associated pruritus
• Date of first enrolment: 08/03/2018
• Target sample size: 58
• Recruitment status: Completed
• URL: https://anzctr.org.au/ACTRN12618000001291.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Open (masking not used);Assignment: Parallel;Type of endpoint: Safety/efficacy;
• Phase: Not Applicable

Countries of recruitment

Pakistan

Contacts

• Name: Dr Tahir Mehmood Khan

• Name: Mr Inayat Ur Rehman

Key inclusion & exclusion criteria

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.

Age minimum: 18 Years
Age maximum: No limit
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Sleep quality;CKD associated pruritus;Chronic Kidney disease;hemodialysis;
Sleep quality
CKD associated pruritus
Chronic Kidney disease
hemodialysis

Renal and Urogenital - Kidney disease

Intervention(s)

Participants will be randomized 1:1 into two group in which one group patients will receive Zolpidem (oral tablet) 10 mg once daily and other group will receive acupressure therapy on acupressure points KI-1 points in both foots. The acupressure therapy will be delivered daily for 8 weeks. The therapy will be applied at acupoint KI-1 (Yongquan) in total 6 minutes with 3 minutes per foot and the applied intensity will be adjusted per patient’s level of tolerance for 8 weeks at North west General Hospital and Research Center Peshawar Pakistan and Institute of Kidney diseases Peshawar. At week 4 and week 8 from the baseline the participants in both groups control and intervention group will be required to fill the PSQI questionnaire to assess improvement in sleep quality and improvement in PSQI score and improvement in quality of life impaired due to poor sleep by EQ5D 3L. Naranjo’s algorithm known to be a valid measure for reporting and authenticating drug-related events will be required to fill All the patients completing 6 weeks of Zolpidem therapy and acupressure therapy will be questioned about any adverse events that they may have experienced after taking Zolpidem (oral tablet) 10 mg once daily. The information will be collected based on the patients experience and the list of the adverse events.

Primary Outcome(s)

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(s)

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).]

Patient acceptability to be assessed by "Treatment Acceptability Questionnaire (TAQ)".
[At baseline (0 week) , 4 weeks and 8 weeks (time point).]

Secondary ID(s)

None

Source(s) of Monetary Support

Monash University Malaysia

Secondary Sponsor(s)

North West General Hospital and Research Center Peshawar Pakistan

Ethics review

Status: Approved
Approval date:
Contact:

North West General Hospital and Resarch center Peshawar Pakistan

Results

• Results available: Yes
• Date Posted: 11/02/2019
• Date Completed: 31/05/2018