Skip to main content
. 2023 Aug 31;2023(8):CD013074. doi: 10.1002/14651858.CD013074.pub2

Balouchi 2016.

Study characteristics
Methods Study design
  • Cross‐over RCT


Study dates
  • Duration of follow‐up: 2 weeks (first phase)

  • Time frame: February 2015 to April 2016

Participants Study characteristics
  • Setting: single centre (centre of Imam Khomeini Hospital in Zabol)

  • Country: Iran

  • Inclusion criteria: patients undergoing HD 3 times/week; having a history of HD treatments > 6 months; informed consent for the study; lack of acute stressful event in the past 6 months (death of loved one sand having an accident); lack of history of allergy to aromas; lack of proven problem in sense of smell (healthy olfactory sense that was evaluated by a physician); AKI

  • Exclusion criteria: unwillingness to participate in the trial; kidney transplantation; hospitalisation in another ward except HD ward for other reasons (MI, CVC, dyspnoea)


Baseline characteristics
  • Number (analysed/randomised): intervention group 1 (not reported/15); intervention group 2 (not reported/15)

  • Mean age ± SD (years): overall (47 ± 14)

  • Sex (M/F): overall (20/10)

  • Dialysis type: HD

  • Mean dialysis vintage ± SD (years): overall (4 ± 2)

  • 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 1
  • Inhalation of lavender extract (essential oil) on even and odd days of the week


Intervention group 2
  • Inhalation of sweet orange extract (essential oil) on even and odd days of the week


Co‐interventions
  • Patients in both groups received routine care as well

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

  • Fatigue

    • MFI‐20: assessed at the beginning of the study, at the beginning of the second week and at the end of the second week (Appendix 3)

      • General fatigue

      • Physical fatigue

      • Mental fatigue

      • Decreased activity

      • Decreased motivation

Notes Additional information
  • Funding: this paper was obtained from student MSc thesis (number: Zbmu.1.Rec.1394.132), that approved in Zabol University of medical science

  • 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 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 a demographic questionnaire and the Multi‐dimensional Fatigue Inventory (MFI‐20)."
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 High risk The number of patients who completed the study was not clearly stated for the first phase. 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. Fatigue at the end of treatment was not reported in a format that was extractable for meta‐analysis (cross‐over study: data related to the first period were not reported). 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 was unlikely to influence the data analysis and conflicts of interest were not reported