Cetinkaya 2019.
Study characteristics | ||
Methods | Design: RCT Date of study: February and June 2018 Power calculation: no Inclusion criteria: the inclusion criteria for the study were 65 years of age or older, no complications during the 3 days of the postoperative period, and willingness to participate in the study. Exclusion criteria: the exclusion criteria were mental retardation that hinders communication, dementia (defined as a Mini‐Mental State Examination [MMSE] score of <23), age < 65 years, hearing problem, development of postoperative complications and unable to speak Turkish. |
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Participants | Sample size: 60 Country: Turkey Setting: orthopaedics clinic in an educational research hospital Age: Mean age 69.86 (± 7.59) Sex: male, 10 (33.3%) in Intervention group, male, 5 (16.7%) in control group Overall: male (15, 25%) Co‐morbidity: there were no differences between groups for the number of chronic diseases, previous surgery or regular use if medication. Dementia: not reported Frailty: not reported |
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Interventions | Intervention: patients were exposed to music for 3 postoperative days after hip or knee surgery. The patients listening to music were supplied with an Mp3 player in their room, in bed. A separate headset was used for each patient. The patients listened to Acemasiran‐type classical Turkish music. Acemasiran‐type music affects the human brain and provides a sense of creativity of people. Each patient in the intervention group listened to the music for 20‐minute sessions three times a day for 3 postoperative days. Control: routine nursing care – no other description provided. |
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Outcomes | Outcomes reported: ‐Incident delirium using The Neecham Confusion Scale Outcomes from study not reported: none Frequency of outcomes assessment: three days postoperatively |
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Notes | Funding source: not reported Declarations of interest: none reported by authors Delirium not excluded at enrolment |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Participants were randomly allocated into two groups by drawing lots using closed envelopes with numbers from 0 to 9. However, authors state – quote: "Those who selected single numbers were allocated to the control group, and those with double numbers formed the intervention group". Assumed to reflect typographical error in the paper. |
Allocation concealment (selection bias) | Unclear risk | Unclear how the allocation to groups was concealed based on method used to generate random allocation |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Patients receiving the intervention were supplied with an MP3 player in their room, blinding not possible. States nurses were blinded, although their role in study is unclear. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Those in the intervention group visited by the researcher. States statistician was blinded to assignment, but role of researcher and statistician not defined in terms of outcome assessment. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | All outcome data reported – no losses to follow‐up |
Selective reporting (reporting bias) | Unclear risk | No published protocol available for review |
Other bias | Low risk | No evidence of other bias |