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

Muz 2017.

Study characteristics
Methods Study design
  • Parallel RCT


Study dates
  • Duration of follow‐up: 1 month

  • Time frame: August 2014 to February 2015

Participants Study characteristics
  • Setting: multicentre (5 HD centres settled in two provinces in Turkey)

  • Country: Turkey

  • Inclusion criteria: ≥ 18 years; no eye or hearing disabilities; voluntary participation in the study; HD for 3 months; continue dialysis in the same unit/centre, undergo HD treatment for 3 sessions/week; not to take any sleeping pill before aromatherapy and during the course of the study; have average or severe fatigue symptoms (VAS fatigue score should be 3 or more); have a score of 5 or more for PSQI; speak Turkish

  • Exclusion criteria: any respiratory system disease; any allergy to essential oils used; any obstacle to smell; use of other integrative medicine applications during treatment


Baseline characteristics
  • Number (analysed/randomised): intervention group (27/41); control group (35/39)

  • Mean age ± SD (years): intervention group (52.26 ± 14.50); control group (59.26 ± 12.43)

  • Sex (M/F): intervention group (18/9); control group (16/19)

  • Dialysis type: HD

  • Mean dialysis vintage ± SD (years): intervention group (6.29 ± 3.91); control group (6.24 ± 5.27)

  • 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


Treatment group
  • Inhalation of sweet orange and lavender oil every day


Control group
  • No intervention


Co‐interventions
  • Not reported

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

  • Sleep quality

    • PSQI (Appendix 3): assessed at baseline and after 1 month

      • Daytime sleepiness dysfunction

      • Subjective sleep quality

      • Sleep latency

      • Sleep duration

      • Habitual sleep efficiency

      • Sleep disturbance

      • Global sleep quality

  • Fatigue

    • 10‐point VAS: assessed at baseline, every week for 1 month

    • PFS (Appendix 3): assessed at baseline, every week for 1 month

  • Behavioural/severity

  • Affective meaning

  • Sensory

  • Cognitive mood

  • Laboratory results (Hb, HCT, albumin, urea, CrCl): assessed at baseline at the end of the study

  • Hospitalisation: assessed until the end of the treatment

Notes Additional information
  • Funding: supported in part by a grant from the Erciyes University Scientific Research Projects Coordination Unit (no. TDK‐2014‐5222)

  • 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 Quote: "Random selection of samples was performed."
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 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: "Visual Analogue Scale (VAS) score, Piper fatigue scale, and Pittsburgh Sleep Quality Index (PSQI) were determined via face‐to‐face interview and patient documents. In the first week (the first follow‐up), second week (second follow‐up), and third week (third follow‐up), Visual Analogue Scale (VAS) score and Piper fatigue scale were obtained by the researcher."
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/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 High risk Figure 1 reported the number of participants who did not complete the follow‐up. 27/41 participants in the intervention group and 35/39 participants in the control group completed the study (> 5% lost to follow‐up, with differences between groups)
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 Low risk There was no evidence of different baseline characteristics, or different non‐randomised co‐interventions between groups. Funding was unlikely to influence the data analysis and authors had no conflicts of interest. The study seemed to be free from other source of bias