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

INTERVENTION: 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. CONDITION: Chronic Kidney disease CKD associated pruritus hemodialysis Sleep quality PRIMARY OUTCOME: Sleep quality assessed by Pittsburgh Sleep Quality Index (PSQI) scores among patients having chronic kidney disease associated pruritus SECONDARY OUTCOME: Adverse events will be monitored by Naranjo’s algorithm known to be a valid measure for reporting and authenticating drug‐related events. Patient acceptability to be assessed by "Treatment Acceptability Questionnaire (TAQ)". ; Quality of life (EQ5D‐3L) will be measured. 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.