| 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
Control group
|
| Outcomes |
|
| Notes |
|
| 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 |