Eroglu 2022.

Study characteristics
Methods	Study design Parallel RCT Study dates Duration of follow‐up: 10 weeks Time frame: May 2019 to October 2019
Participants	Study characteristics Setting: multicentre (2 dialysis clinics) Country: Turkey Inclusion criteria: ≥ 18 years; capable of communicating in Turkish; HD history of at least 3 months and actively receiving HD 2 or 3 times/week; reporting willingness to participate in this study Exclusion criteria: aggravated conditions who would not be able to continue with the study; other accompanying diseases that may directly affect the fatigue severity such as chronic obstructive pulmonary disease, advanced heart failure, asthma, and malignant tumours; diagnosed with anxiety or major depression by a psychiatrist; could not communicate in Turkish; used another complementary and integrative approach within the study period Baseline characteristics Number (analysed/randomised): intervention group (30/31); control group (31/31) Mean age ± SD (years): intervention group (52.0 ± 15.16); control group (58.68 ± 14.57) Sex (M/F): intervention group (15/15); control group (20/11) Dialysis type: HD Dialysis vintage (years) (mean ± SD): not reported Comorbidities CVD: not reported Diabetes: intervention group (6/30); control group (12/31) Hypertension: intervention group (17/30); control group (13/31) Depression (clinician diagnosis): not reported
Interventions	Intervention classification Non‐pharmacological intervention Indication: study targeting fatigue Intervention group Benson relaxation technique combined with music therapy for 8 weeks Control group No intervention for 8 weeks Co‐interventions Not reported
Outcomes	Outcomes reported Fatigue outcome measures used: validation data not available Fatigue PFS: assessed at baseline, weeks 4, 8, 10 Behavioural/severity Affective Sensory Cognitive/mood Anxiety HADS: assessed at baseline, weeks 4, 8, 10 (Appendix 3) Depression HADS: assessed at baseline, weeks 4, 8, 10
Notes	Additional information Funding: This study was a masters dissertation of H.E. and Z.G.M. was the advisor Conflicts of interest/disclosures: none Trial registration identification number: NCT04299256 A priori published protocol was 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	Quote: "A blinded study could not be conducted as per the limitations of blinding for non‐pharmacological tests."
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	Quote: "The second investigator randomly assigned all the participants to the intervention group (n = 31) and the control group (n = 31) in a 1:1 ratio using a random number table. After the allocation of all participants, 1 patient in the intervention group did not want to participate due to psychological/familial issues. Finally, the study was completed with a total of 61 patients, 30 in the intervention group and 31 in the control group." Comment: 30/31 participants in the intervention group and 31/31 participants in the control group completed the study (< 5% loss to follow‐up with slight differences between groups). Reasons for discontinuation were provided and they were not related to the intervention
Selective reporting (reporting bias)	High risk	Protocol was published. Fatigue was reported (Unruh 2013) in accordance with a pre‐specified analysis plan, using multiple eligible outcome measurements (scales, time points). 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	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. No other source of bias were apparent