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

Jalalian 2015.

Study characteristics
Methods Study design
  • Parallel RCT


Study dates
  • Duration of follow‐up: 2 months

  • Time frame: not reported

Participants Study characteristics
  • Setting: single centre (hospital of Tehran University of Medical Science)

  • Country: Iran

  • Inclusion criteria: maintenance HD patients

  • Exclusion criteria: not reported


Baseline characteristics
  • Number (analysed/randomised): overall (not reported/64)

  • Mean age ± SD (years): not reported

  • Sex (M/F): not reported

  • 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
  • Lavender and sweet orange essence


Control group
  • No intervention


Co‐interventions
  • Not reported

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

  • Fatigue

    • Rhoten fatigue scale: assessed before and after the treatment

  • HRQoL

    • KDQOL‐SF: assessed before and after the treatment

Notes Additional information
  • Funding: not reported

  • Conflicts of interest/disclosures: not reported

  • Trial registration identification number: not reported

  • A priori published protocol: not reported

  • Abstract‐only publication

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: "Data were collected using demographic questionnaire, Rhoten Fatigue Scale and Kidney Disease Quality of Life Short Form (KDQOLSF)."
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, other subjective outcome were reported
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. 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. Information related to fatigue were not reported in sufficient detail to permit judgment. All outcomes that should be addressed (fatigue, cardiovascular disease, and death) were not reported
Other bias Unclear risk No data were available to assess the possible imbalance between groups. Funding and conflicts of interest were not reported