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. 2019 Jul 5;2019(7):CD012598. doi: 10.1002/14651858.CD012598.pub2

Rad 2017.

Methods
  • Study design: parallel RCT

  • Follow‐up period: 2 weeks

  • Duration of study: December 2014 to March 2015

Participants
  • Country: Iran

  • Setting: multicentre (dialysis centre of Imam Reza Hospital and dialysis centres affiliated to Imam Reza hospital (Bentolhoda and AL‐ Muhammad) of Mashhad city)

  • Inclusion criteria: consent for participation in the study; aged 18 to 65 years; suffering from vision, hearing loss (deafness and dumbness); not suffering from clear mental disorders and severe emotional mood disorders, which prevent effective communication; patients with chronic renal failure (patients who 3 months have passed since their dialysis); patients who have arteriovenous fistulas for HD; patients receiving dialysis treatment 3 times/week and each session for 4 hours; patients who over the past 2 months, have a history of itching during HD; not suffering from endocrine disorders (such as hypothyroidism, hyperparathyroidism; not suffering from febrile illnesses (pneumonia, colds); no history of pruritic skin diseases; no use of medications or foods, causing itching; lack of pregnancy and liver problems; patients with a KT / V ≥ 1; patients with Hb of 10 to 11 mg/dL

  • Number: treatment group (30); control group (30)

  • Mean age ± SD: treatment group (53.10 ± 10.02); control group (55.83 ± 8.45)

  • Sex (M/F): treatment group (17/13); control group (15/15)

  • Exclusion criteria: patients who develop acute complications during HD (disequilibrium syndrome, embolism, dysrhythmia, cardiac or respiratory arrest, coma); patients with skin disorders that feature itchiness (scabies, psoriasis); patients who discontinued their dialysis for any reason; patients who are referred for kidney transplants (patients who had kidney transplantations during the study); change in the frequency of HD, the patient's death, patients who cannot tolerate cold dialysis; female patients who become pregnant; HD with acetate; the incidence of fever; unwillingness to continue to participate in the study

Interventions Treatment group
  • Temperature of HD fluid is regulated at 35.5°C and type of filter, coefficient of ultra‐ filtration, blood flow rate are not changed


Control group
  • Temperature of HD fluid (dialysate) is regulated at 37°C. Type of filter, coefficient of ultra‐filtration, blood flow rate and type of apparatus are constant during the study

Outcomes
  • Dropout rate due to adverse events

Notes
  • Funding source: not reported

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk The random permuted block method was used, but there was no description how to generate the random sequence
Allocation concealment (selection bias) Unclear risk Insufficient information to permit judgement
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Blinding was not feasible because of the nature of the intervention
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk The assessors were blinded
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk Insufficient information to permit judgement: The only measured outcome was "dropouts due to adverse events" and no dropouts occurred
Selective reporting (reporting bias) High risk Insufficient information to permit judgement: The pruritus outcome was not measured by one of the pre‐specified measures
Other bias Low risk No concern about the baseline imbalance