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. 2023 Aug 31;2023(8):CD013074. doi: 10.1002/14651858.CD013074.pub2

Habibzadeh 2020.

Study characteristics
Methods Study design
  • Parallel RCT


Study dates
  • Duration of follow‐up: 2 months

  • Time frame: June 2016 to April 2017

Participants Study characteristics
  • Country: Iran

  • Setting: multicentre (Taleghani and Imam Khomeini in Urmia, Iran)

  • Inclusion criteria: ESKD undergoing HD; willingness to participate in the study; at least 6 months on HD; no presence of infectious diseases (including all types of hepatitis); no recent severe psychological problem (e.g. psychosis or mania); lack of attendance in similar training courses (including massage courses); 18 and 85 years; male gender (due to the male being the interventionist to eliminate potential intervention biases and considering the cultural issues of Iran); attendance in dialysis sessions at least 3 times/week; at least elementary school education; no history of sensitivity, arthritis, rheumatoid arthritis or joint and orthopaedic problems; and lack of using sedative and analgesic and regenerative drugs

  • Exclusion criteria: unwillingness to continue participation in the study; kidney transplantation during the study; onset of other illnesses; withdrawal from the HD program


Baseline characteristics
  • Number (analysed/randomised): intervention group 1 (30/30); intervention group 2 (30/30); intervention group 3 (30/30); control group (30/30)

  • Mean age ± SD (years): overall (55.2 ± 12.7)

  • Sex (M/F): intervention group 1 (30/0); intervention group 2 (30/0); intervention group 3 (30/0); control group (30/0)

  • Dialysis type: HD

  • Mean dialysis vintage ± SD (years): overall (4.70 ± 2.53)

  • Comorbidities

    • CVD: not reported

    • Diabetes: not reported

    • Hypertension: not reported

    • Depression: not reported

Interventions Intervention classification
  • Non‐pharmacological intervention

  • Indication: study targeting fatigue


Intervention group 1
  • Foot massage with chamomile oil


Intervention group 2
  • Foot massage with almond oil


Intervention group 3
  • Foot massage with no oils


Control group
  • No intervention


Co‐interventions
  • Not reported

Outcomes Outcomes reported
  • Fatigue outcome measures used: validation data available

  • Fatigue

  • QoL aspects

  • KDQOL‐SF (Appendix 3)

Notes Additional information
  • Funding: Master degree thesis of Osman Wosoi Dalavan by Urmia University of Medical Sciences

  • Conflicts of interest/disclosures: none

  • Trial registration identification number: IRCT2016121731438N1

  • A priori published protocol was reported

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "Participants were randomly allocated into four groups (three intervention and one control group) by the first researcher. Numbers 1 through 120 were written on a small paper and placed in a basket; the participants were asked to take a number from the basket and classified based on this number (1 to 30 in the control group, 31 to 60 in the “Foot massage with chamomile oil group”, 61 to 90 in the “Foot massage with almond oil group” and 91 to the last in the “Foot massage without oil group”)."
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 Quote: "Both participants and researcher were blind to participant allocation; however, due to noticeable differences in the oils used in foot massage, it was not possible to blind the researcher who performed the foot massage intervention and participants."
Blinding of outcome assessment (detection bias)
All outcomes High risk It was not clear if fatigue was 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, other subjective outcome were reported
Incomplete outcome data (attrition bias)
All outcomes Low risk All participants completed the study and there were no lost to follow‐up
Selective reporting (reporting bias) High risk Protocol was published. Fatigue was reported in accordance with a pre‐specified analysis plan, 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 not involved in the design, execution, analysis, or reporting of the results of this study. The study seemed to be free from other source of bias