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

Cecen 2021.

Study characteristics
Methods Study design
  • Quasi‐RCT


Study dates
  • Duration of follow‐up: 4 weeks

  • Time frame: October 2018 to February 2019

Participants Study characteristics
  • Setting: single centre (public hospital)

  • Country: Turkey

  • Inclusion criteria: receiving HD in the dialysis unit of a public hospital in Turkey; written consent to participate in the study; > 18 years; open to communication; able to speak and understand Turkish; receiving HD 3 times/week for ≥ 6 months; no loss of sensation, mass, fracture or ingrown toenail (onyxis); lower extremities free from pathological and tumoral disease; no symptoms of phlebitis, embolism and no bleeding disorder related to amputation, fracture, infection, wound, skin disease in patients > 65 years: SMMT score ≥ 24

  • Exclusion criteria: not providing written consent to participate, < 18 years; HD twice/week for 6 months or less; loss of sensation, mass, fracture or ingrown toenail (onyxis) in patients > 65 years, SMMT score ≤ 23


Baseline characteristics
  • Number (analysed/randomised): intervention group 1 (27/28); intervention group 2 (27/28); control group (28/28)

  • Mean age ± SD (years): intervention group 1 (53.07 ± 18.13); intervention group 2 (59.96 ± 16.47); control group (55.36 ± 15.02)

  • Sex (M/F): intervention group 1 (17/10); intervention group 2 (9/18); control group (13/15)

  • Dialysis type: HD

  • Mean dialysis vintage ± SD (years): intervention group 1 (5.5 ± 5.6); intervention group 2 (4.4 ± 3.9); control group (6.3 ± 4.7)

  • Comorbidities

    • CVD: not reported

    • Diabetes: intervention group 1 (12/27); intervention group 2 (13/27); control group (7/28)

    • Hypertension: intervention group 1 (19/27); intervention group 2 (22/27); control group (19/28)

    • Depression (clinician diagnosis): not reported

Interventions Intervention classification
  • Non‐pharmacological intervention

  • Indication: study targeting fatigue


Intervention group 1
  • Hand massage


Intervention group 2
  • Foot massage


Control group
  • No intervention


Co‐interventions
  • Not reported

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

  • Fatigue

    • 10‐point VAS: baseline, weeks 2 and 4

  • Mental health

    • SMMT (Appendix 3)

      • Time and space orientation

      • Recording memory

      • Attention

      • Recall

      • Language

  • Hb

  • HCT

  • Ferritin

  • BUN

  • Creatinine

  • Energy

    • 10‐point VAS (baseline, weeks 2 and 4)

Notes Additional information
  • Funding: none

  • 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) High risk Since the study was a quasi‐experimental trial, no random element was used in generating the allocation sequence or the sequence was predictable
Allocation concealment (selection bias) High risk Method of allocation concealment was not reported in sufficient detail to permit judgement. However, since the study was a quasi‐experimental trial, there was a reason to suspect that the enrolling investigator or the participant had knowledge of the forthcoming allocation. No imbalance between intervention groups was apparent
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/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 Quote: "The patients involved in the preliminary application were included in the number of samples and new patients who met the criteria in each group of 28 patients were included in the groups by computerized randomisation and a total of 84 patients was reached. Since one patient from the hand massage group left the dialysis canter temporarily after the fifth massage session, and one patient from the foot massage group died after being taken to the intensive care prior to the fourth session, one patient from each group was excluded from the research. As a result, a total of 82 patients, including 27 patients in each of the hand massage and foot massage groups, and 28 patients in the control group, formed the sample of the research."
Comment: 54/56 participants in the intervention groups and 28/28 in the control group completed the study (< 5% loss to follow‐up). Differences between subgroups were reported. Reasons for discontinuation were reported
Selective reporting (reporting bias) High risk Information about the protocol and the statistical analysis plan was 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