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

Ozdemir 2013.

Study characteristics
Methods Study design
  • Parallel RCT


Study dates
  • Duration of follow‐up: 1 week

  • Time frame: not reported

Participants Study characteristics
  • Setting: multicentre (HD units of two institutions in the city of Gaziantep located in the Southeastern Anatolia region of Turkey)

  • Country: Turkey

  • Inclusion criteria: ≥ 18 years; full consciousness and orientation; did not have any communication problems; HD 3 times/week for at least 6 months; marked level of severity of fatigue, pain and cramp as at least 1 in VAS; volunteered to participate in the research

  • Exclusion criteria: patients with open foot wound; suspicious fracture; burn; deep vein thrombosis; peripheral neuropathy


Baseline characteristics
  • Number (analysed/randomised): intervention group (not reported/40); control group (not reported/40)

  • Mean age ± SD (years): intervention group (43.1 ± 15.8); control group (54.0 ± 12.8)

  • Sex (M/F): intervention group (13/27); control group (17/23)

  • 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 for 30 minutes, 3 times/week for 1 week


Control group
  • No intervention


Co‐interventions
  • Not reported

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

  • Fatigue

    • PFS (Appendix 3) (assessed at baseline and after 1 week)

      • Behavioural/severity

      • Affective meaning

      • Sensory

      • Cognitive/mood

  • Pain

    • 10‐point VAS (Appendix 3): assessed at baseline and after 1 week

  • Cramps

    • 10‐point VAS (Appendix 3): assessed at baseline and after 1 week

  • Laboratory results (Hb, HCT, albumin, URR): assessed at baseline and after 1 week

  • Kt/V: assessed at baseline and after 1 week

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) Low risk Quote: "Randomization was performed by MedCalc software to give equal chance to each intervention group."
Comment: Computer‐generation is considered as low risk of bias. No imbalance between intervention groups was apparent
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: "The data of the intervention and control groups were collected by using the questionnaire, Piper Fatigue Scale and Visual Analogue Scale (VAS)."
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 The number of patients who completed the study was not clearly stated. 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 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