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

Karadag 2019.

Study characteristics
Methods Study design
  • Parallel RCT


Study dates
  • Duration of follow‐up: 30 days

  • Time frame: March and December 2017

Participants Study characteristics
  • Setting: multicentre (unit of Gaziantep University Sahinbey Research and Application Hospital located in a province in southeastern Turkey)

  • Country: Turkey

  • Inclusion criteria: receiving HD regularly for at least 6 months; being capable of communicating and having no problems of hearing and speech; 18 and 65 years; no smelling problem, no history of eczema, asthma, herbal allergy; no allergy to lavender; not diagnosed with psychiatric disorder; participating in the study voluntarily

  • Exclusion criteria: not reported


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

  • Mean age ± SD (years): intervention group (55.76 ± 13.23); control group (46.43 ± 14.23)

  • Sex (M/F): intervention group (13/17); control group (11/19)

  • Dialysis type: HD

  • Mean dialysis vintage ± SD (years): intervention group (4.5 ± 4.4); control group (3.7 ± 3.8)

  • 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 oil


Control group
  • No intervention


Co‐interventions
  • Not reported

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

  • Fatigue

  • Anxiety

Notes Additional information
  • Funding: not reported

  • Conflicts of interest/disclosures: none

  • 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 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 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 were included into the analysis. There were no lost to follow‐up
Selective reporting (reporting bias) High risk Information about the protocol and the statistical analysis plan were not 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 There was no evidence of different baseline characteristics, or different non‐randomised co‐interventions between groups. Funding was not reported