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

Shahdadi 2016.

Study characteristics
Methods Study design
  • Parallel RCT


Study dates
  • Duration of follow‐up: 3 weeks

  • Time frame: 2015 (months were not reported)

Participants Study characteristics
  • Setting: single centre (Imam Khomeini Hospital dialysis centre in the city of Zabolin)

  • Country: Iran

  • Inclusion criteria: ≥ 18 years; history of at least 6 months of dialysis; willingness to participate in research; being on the list of weekly dialysis and carrying out HD 3 times/week and 4 to 32 hours each time; no history of reflexology in the last 6 months; having full consciousness; listening and speaking acceptable ability to answer the questions; the lack of chronic pain and diabetes; having a degree of fatigue; a minimum score of fatigue between (10 to 39) based on questionnaires fatigue severity

  • Exclusion criteria: death of the patient; mental and sensory disorders; perform a kidney transplant during the study; patient revised in collaboration with researchers during the study and not to be pleased to be working


Baseline characteristics
  • Number (analysed/randomised): intervention group (26/26); control group (26/26)

  • Mean age ± SD (years): intervention group (47.42 ± 12.51); control group (47.04 ± 10.57)

  • Sex (M/F): intervention group (21/5); control group (15/11)

  • 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
  • Slow stroke back massage


Control group
  • No treatment


Co‐interventions
  • Not reported

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

  • Fatigue

Notes Additional information
  • Funding: not reported

  • Conflicts of interest/disclosures: not reported

  • Trial registration identification number: not reported

  • A priori published protocol: not reported

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: "The subjects were randomly divided into two groups."
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 High risk Not reported. However, interventions were different and investigators could be aware of the treatment assigned
Blinding of outcome assessment (detection bias)
All outcomes High risk Quote: "The data collecting tool was included Individual demography and fatigue severity questionnaire."
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
Incomplete outcome data (attrition bias)
All outcomes Unclear risk All participants completed the study. However, it was not stated if some patients discontinued
Selective reporting (reporting bias) High risk Information about the protocol and the statistical analysis plan were not 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 Unclear risk There was no evidence of different baseline characteristics, or different non‐randomised co‐interventions between groups. Funding and conflicts of interest were not reported