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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12618000001291
Enrollment
58
Registered
2018-01-08
Start date
2018-03-08
Completion date
2018-03-31
Last updated
2019-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This study aims to determine whether acupressure therapy will be able to improve sleep quality in patients having chronic kidney disease (CKD) associated pruritus on hemodialysis. Other outcomes include change in quality of life and patient acceptability acupressure application. previous study of acupressure on sleep quality among hemodialysis patients showed positive impact on improving the sleep quality.

Interventions

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 Genera

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.

Sponsors

Monash University Malaysia
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used) (Subject, Investigator)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

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.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026