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

Sajadi 2016.

Methods

  • Study design: cross‐over RCT

  • Follow‐up period: 2 months

  • Duration of study: August 2014 to 31 October 2014
Participants

  • Country: Iran

  • Setting: single centre

  • Inclusion criteria: aged > 18 years old; experiencing some degree of fatigue (mild, moderate, and severe); referring consistently and regularly 3 times/week for receiving HD, receiving HD for at least 6 months, having haemodynamic stability, being able to listen and speak, having an acceptable level of alertness for responding to questions, having no dependence on narcotics, and no chronic anaemia (Hb < 8 g/dL)

  • Enrolled: 46

  • Age: 58.46 ± 13.46 years

  • Sex (M/F): 25/21

  • Exclusion criteria: not reported
Interventions Treatment arm

  • 3 sessions of HD in the week (every other day) with a solution temperature of 35.5°C


Control arm

  • 3 sessions of HD in the week (every other day) with a 37°C solution
Outcomes

  • Discomfort rate defined as cold sensation, shivering, and related symptoms

  • Post‐HD fatigue
Notes

  • Funding source: Arak University of Medical Sciences

  • We requested further information but there was no response
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Study was described as randomised; method of randomisation was not reported
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 Unclear risk Insufficient information to permit judgement
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk Insufficient information to permit judgement: No description about the first phase data including missing values
Selective reporting (reporting bias) High risk Primary outcome was reported with multiple cut‐offs
Other bias High risk Carry‐over effects potentially existed. No description for the assessment of the baseline imbalance of first period of the cross‐over study