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

Bagheri‐Nesami 2016.

Study characteristics
Methods Study design

  • Parallel RCT


Study dates

  • Duration of follow‐up: 4 weeks

  • Time frame: not reported
Participants Study characteristics

  • Setting: multicentre (2 hospitals affiliated with the Mazandaran University of Medical Sciences, Sari)

  • Country: Iran

  • Inclusion criteria: be willing to participate in the study; be treated with dialysis three times a week; be undergoing dialysis for at least six months; ≥ 18 years old; be conscious; have the ability to verbally communicate; have an uncompromised sense of smell

  • Exclusion criteria: patients with a history of allergies and respiratory diseases; kidney transplant candidates; pregnant women; drug addicts


Baseline characteristics

  • Number (analysed/randomised): intervention group (29/30); control group (30/30)

  • Mean age ± SD (years): intervention group (62.31 ± 14.46); control group (59.33 ± 12.80)

  • Sex (M/F): intervention group (17/12); control group (21/9)

  • Dialysis type: HD

  • Mean dialysis vintage ± SD (years): intervention group (3.54 ± 3.00); control group (3.49 ± 2.31)

  • Comorbidities

    • CVD: not reported

    • Diabetes: intervention group (3/29); control group (4/30)

    • Hypertension: intervention group (8/29); control group (10/30)

    • Depression (clinician diagnosis): not reported
Interventions Intervention classification

  • Non‐pharmacological intervention

  • Indication: study targeting fatigue


Intervention group

  • Inhalation of lavender essence (5%) 3 times/week


Control group

  • Routine care


Co‐interventions

  • Not reported
Outcomes Outcomes reported

  • Fatigue outcome measures used: validation data available

  • Fatigue

    • FSS (Appendix 3)

      • Physical fatigue

      • Mental fatigue

      • Effect of fatigue on a person's social life
Notes Additional information

  • Funding: not reported

  • Conflicts of interest/disclosures: none

  • Trial registration identification number: IRCT201407077494N9

  • A priori published protocol was reported
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "The sample was randomly allocated in two groups using the Excel RANDBETWEEN function."
Comment: Sequence generation was performed using Excel RANDBETWEEN. 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 Low risk Quote: "Fatigue was measured using the Fatigue Severity Scale in both groups for a total of three times (before the intervention, and after the last intervention in the second and fourth weeks) by only one researcher who was blind to the treatment allocation."
Comment: The outcomes were assessed with an appropriate measure, without differences between groups. However, subjective measures were used, it was stated that the interviewer was blinded to the intervention. 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 Low risk Quote: "Only one patient from the experimental group was excluded because of an infection, resulting in 29 patients in the experimental group and 30 patients in the routine care group."
Comment: 29/30 participants in the intervention group and 30/30 participants in the control group completed the study (<5% lost to follow‐up). Reasons for discontinuations seemed to be not related to the treatment allocation
Selective reporting (reporting bias) High risk Protocol was provided. Fatigue was reported in accordance with a pre‐specified analysis plan, using multiple eligible outcome measurements (scales, time points). Fatigue at the end of treatment 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 was not reported and authors had no conflicts of interest