Roshanravan 2016.

Study characteristics
Methods	Study design Parallel RCT Study dates Duration of follow‐up: 4 weeks Time frame: 2013 (months were not reported)
Participants	Study characteristics Setting: multicentre (Imam‐Ali and Mehreiran clinic in Bojnurd) Country: Iran Inclusion criteria: ≥ 18 years; dialysis for at least 3 months; HD 3 times/week and 4 hours each time; no history of limb amputation or wounds in massage zone; no history of chronic or disabling disease (cancers, COPD, heart failure, rheumatoid arthritis and SLE); no physically handicapped and psychotic disorders that makes patients unable to cure themselves individually Exclusion criteria: kidney transplantation or PD; haemodynamic complication in most dialysis sessions; death or refusal to be in the study Baseline characteristics Number (analysed/randomised): intervention group (26/27); control group 1 (25/27); control group 2 (27/27) Mean age ± SD (years): overall (48.91 ± 15.46) Sex (M/F): intervention group (14/12); control group 1 (13/12); control group 2 (14/13) Dialysis type: HD Dialysis vintage (years) (mean ± SD): not reported Comorbidities CVD: not reported Diabetes: not reported Hypertension: not reported Depression (clinician diagnosis): not reported
Interventions	Intervention classification Non‐pharmacological intervention Indication: study targeting fatigue Intervention group Foot reflexology Control group 1 Sham foot reflexology without pressing certain parts of the foot Control group 2 Routine care (no intervention) Co‐interventions Not reported
Outcomes	Outcomes reported Fatigue outcome measures used: validation data available Fatigue PFS (Appendix 3): assessed before and after the treatment Behavioural/intensity Emotional Sensory Cognitive/mood Death: assessed until the end of treatment Hospitalisation: assessed until the end of treatment
Notes	Additional information Funding: this article is the result of a master's degree in intensive care thesis and a proposal approved by the Nursing Research Center. Thereby we thank Deputy of Research and technology of Golestan University of medical sciences for their financial support Conflicts of interest/disclosures: not reported Trial registration identification number: IRCT201307077821N5 A priori published protocol were reported. The study was approved by the Golestan medical university Ethics Committee (no clearly stated if this information was related to the protocol) Not English
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	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	High risk	Not reported. However, interventions were different and participants and/or investigators could be aware of the treatment assigned
Blinding of outcome assessment (detection bias) All outcomes	High risk	Quote: "Patients filled the questionnaire when their dialysis has been completed and have been disconnected from the dialysis machine." 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. However, objective and subjective outcomes were assessed
Incomplete outcome data (attrition bias) All outcomes	High risk	26/27 participants in the intervention group (foot reflexology), 25/27 participants in the control group 1 (sham) and 27/27 participants in the control group 2 (no treatment) completed the study (> 5% lost to follow‐up, with differences between groups). Reasons for discontinuations were not reported
Selective reporting (reporting bias)	High risk	Information about the protocol and the statistical analysis plan were reported. Fatigue was reported using multiple eligible outcome measurements (scales, time points). Fatigue was reported in a format that was extractable for meta‐analysis. All outcomes that should be addressed (fatigue, cardiovascular disease, and death) were not reported
Other bias	Low risk	There was no evidence of different baseline characteristics, or different non‐randomised co‐interventions between groups. Funding was unlikely to influence the data analysis and conflicts of interest were not reported