Sajadi 2016.

Study characteristics
Methods	Study design Cross‐over RCT Study dates Duration of follow‐up: 1 week Time frame: August to October 2014
Participants	Study characteristics Setting: single centre (HD unit of Vlieasr Hospital in Arak) Country: Iran Inclusion criteria: ≥ 18 years; afflicted to some degrees 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 Exclusion criteria: dependence on narcotics; chronic anaemia (Hb < 8 g/dL) Baseline characteristics Number (analysed/randomised): intervention group 1 (not reported/23); intervention group 2 (not reported/23) Mean age ± SD (years): overall (58.46 ± 13.46) Sex (M/F): intervention group 1 (9/14); intervention group 2 (16/7) Dialysis type: HD Mean dialysis vintage ± SD (years): overall (3.55 ± 3.90) Comorbidities CVD: not reported Diabetes: not reported Hypertension: not reported Depression (clinician diagnosis): not reported
Interventions	Intervention classification Pharmacological intervention Indication: study targeting fatigue Intervention group 1 Cold dialysis solution temperature of 35.5°C Intervention group 2 Dialysis solution temperature of 37°C (conventional temperature solution) Co‐interventions Each group received 3 sessions of HD, each time for 4 hours
Outcomes	Outcomes reported Fatigue outcome measures used: validation data available Fatigue PFS (Appendix 3): assessed at weeks 0 and 1 Behavioural Emotional Sensory Temperamental/cognitive Vital signs (BP, heartbeat) Digital arm‐fit stethoscope: assessed before, during, and after dialysis Armpit temperature Mercury‐filled thermometer: assessed before and after dialysis
Notes	Additional information Funding: This article is part of a Master’s of Science thesis approved by Arak University of Medical Sciences (project number, 2019); Arak University of Medical Sciences supporting the study by a research grant Conflicts of interest/disclosures: none Trial registration identification number: IRCT2014082518928N1 A priori published protocol was reported
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Quote: "The participants were allocated into 2 groups through simple random sampling method." Comment: Sequence generation methods were not reported in sufficient detail to permit judgement
Allocation concealment (selection bias)	Unclear risk	Method of allocation concealment was not reported in sufficient detail to permit judgement
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Quote: "In a double‐blinded cross‐over clinical trial, 46 participants were recruited from a haemodialysis unit in Iran." Comment: Although author reported that the study used a double‐blind design, information about blinding of participants and investigators were not clearly stated
Blinding of outcome assessment (detection bias) All outcomes	High risk	Quote: "A self‐reported questionnaire was used to collect data. [...] The researcher read and completed it for illiterate patients." Comment: The outcomes were assessed with an appropriate measure, without differences between groups. However, subjective measures were used, it was not stated whether outcomes were assessed without knowledge of treatment allocation, and knowledge of treatment assignment may have influenced reporting. Participant beliefs about the superiority/inferiority of either intervention could have influenced their assessment of the outcome, but there was no evidence that this was likely. Other objective outcomes were assessed
Incomplete outcome data (attrition bias) All outcomes	High risk	The number of patients who completed the study was not clearly stated for the first period. It was unclear if there was evidence that the results were not biased by missing outcome data
Selective reporting (reporting bias)	High risk	Information about the protocol and the statistical analysis plan were reported. It was not reported if multiple eligible outcome measurements (scales and time points) were pre‐specified. It was unclear if the reported approach to analysing this outcome was pre‐specified or influenced by the results. Fatigue at the end of treatment was not reported in a format that was extractable for meta‐analysis (cross‐over study: data related to the first period were not clearly reported). All outcomes that should be addressed (fatigue, cardiovascular disease, and death) were not reported
Other bias	Unclear risk	Baseline characteristics between groups were not reported in sufficient detail. Funding was unlikely to influence the data analysis and reporting and authors had no conflicts of interest