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

Hadadian 2018.

Study characteristics
Methods Study design
  • Parallel RCT


Study dates
  • Duration of follow‐up: 1 month

  • Time frame: 2011 (months were not reported)

Participants Study characteristics
  • Setting: single centre (Imam Reza Hospital in Kermanshah)

  • Country: Iran

  • Inclusion criteria: receiving HD treatment for at least 6 months; willingness to participate in the study; ≥ 15 years; complete awareness of the situation; hearing and speaking ability as needed to learn the technique; and no psychological disease

  • Exclusion criteria: lack of willingness to learn relaxation technique; failure to attend the training course; hospitalization for whatever reason; encountering physical or mental problems during the study


Baseline characteristics
  • Number (analysed/randomised): intervention group (not reported/27); control group (not reported/38)

  • Mean age ± SD (years): overall (52.66 ± 2.007)

  • Sex (M/F): overall (28/37)

  • 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
  • Progressive muscle relaxation


Control group
  • No treatment


Co‐interventions
  • Not reported

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

  • Fatigue

Notes Additional information
  • Funding: Research and Technological department of the University

  • 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 It was not clear how fatigue was assessed, although an appropriate measure was used. 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
Incomplete outcome data (attrition bias)
All outcomes High risk Not reported in sufficient detail to perform adjudication
Selective reporting (reporting bias) High risk Information about the protocol and the statistical analysis plan were not reported. Fatigue was not clearly reported. Fatigue was reported in a format that was not 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