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

Varaei 2020.

Study characteristics
Methods Study design
  • Parallel RCT


Study dates
  • Duration of follow‐up: 16 weeks

  • Time frame: not reported

Participants Study characteristics
  • Setting: multicentre (3 teaching hospitals affiliated to Tehran University of Medical Sciences, Tehran, Iran)

  • Country: Iran

  • Inclusion criteria: > 18 years; minimal HD history of 1 year; 3 HD sessions/week; healthy olfactory function and no history of allergic rhinitis or respiratory disorders; no allergy to aromatic herbs; no participation in aromatherapy or massage therapy programs during the last 6 months before the study; not to take any sleeping pill before aromatherapy and during the course of the study; no history of foot amputation or active skin lesion in the feet; no addiction to opioids; no affliction by debilitating chronic physical conditions such as cardiac, respiratory, liver, or mental disorders according to patients’ medical records

  • Exclusion criteria: death during the study; kidney transplantation during the study


Baseline characteristics
  • Number (analysed/randomised): intervention group 1 (32/32); intervention group 2 (32/32); control group (32/32)

  • 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 1
  • Inhalation aromatherapy with lavender essence oil


Intervention group 2
  • Massage aromatherapy with sweet orange essence oil


Control group
  • No intervention


Co‐interventions
  • Dialysis routine care

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

  • Fatigue

    • Rhoten fatigue 10‐point VAS scale: assessed at baseline, week 8 and 16

  • BP

Notes Additional information
  • Funding: The Tehran Faculty of Nursing and Midwifery and Tehran University of Medical Sciences, Tehran

  • Conflicts of interest/disclosures: none

  • Trial registration identification number: IRCT2014101819564N1

  • A priori published protocol was 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 Quote: "This was a three‐group single‐blind randomised controlled trial."
Comment: A single blind study is considered as high risk of bias
Blinding of outcome assessment (detection bias)
All outcomes Low risk Quote: "The biostatistician who analysed the study data was blind to the interventions."
Comment: Fatigue 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. Other subjective outcomes were assessed. However, the outcome assessment was blinded
Incomplete outcome data (attrition bias)
All outcomes Low risk All participants completed the study and there was no lost to follow‐up
Selective reporting (reporting bias) High risk Information about the protocol were 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 Baseline characteristics were not clearly reported. Funding was unlikely to influence the data analysis and authors had no conflicts of interest