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

Mohammadpourhodki 2021.

Study characteristics
Methods Study design
  • Parallel RCT


Study dates
  • Duration of follow‐up: 4 weeks

  • Time frame: April to July 2019

Participants Study characteristics
  • Setting: single‐centre (HD Unit)

  • Country: Iran

  • Inclusion criteria: ability to verbally communicate; 18 to 65 years; history of dialysis for at least 3 months; receiving 3 sessions of HD/week; no allergy to Lavender and Citrus Aurantium; no experience with massage or aromatherapy; not candidate for kidney transplantation at the time of the study; no history of substance abuse; no serious complication in the lower extremities such as diabetic foot ulcer, peripheral neuropathy, and vascular problems based on the physician’s examination

  • Exclusion criteria: withdrawal of dialysis during the study for any reason (such as travel, migration, kidney transplant, and patient death)


Baseline characteristics
  • Number (analysed/randomised): intervention group 1 (35/35); intervention group 2 (35/35); control group (35/35)

  • Mean age ± SD (years): intervention group 1 (50.58 ± 14.05); intervention group 2 (50.42 ± 17.44); control group (57.60 ± 16.40)

  • Sex (M/F): intervention group 1 (25/10); intervention group 2 (23/12); control group (20/15)

  • Dialysis type: HD

  • Mean dialysis vintage ± SD (years): overall (3.4 ± 2.0)

  • 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
  • Lavender essential oil


Intervention group 2
  • Citrus Aurantium essential oil


Control group
  • No intervention


Co‐interventions
  • Not reported

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

  • Fatigue

  • FSS (Appendix 3)

  • QoL

    • SF‐36 (Appendix 3)

      • Physical and social function

      • Emotional role

      • Bodily pain

      • General health

      • Vitality

      • Mental health

  • Sleep

    • PSQI

Notes Additional information
  • Funding: none

  • Conflicts of interest/disclosures: none

  • Trial registration identification number: IRCT20180711040432N2

  • A priori published protocol was reported

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: "Block randomisation."
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 Quote: "Not blinded."
Blinding of outcome assessment (detection bias)
All outcomes High risk Fatigue was 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/investigators 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 Low risk All participants completed the study. There were no lost to‐follow‐up
Selective reporting (reporting bias) High risk Protocol was published. 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 Low risk There was no evidence of different baseline characteristics, or different non‐randomised co‐interventions between groups. There was no source of funding or conflict of interests. No other source of bias were apparent