Gilbert 1993.
Methods | RCT. | |
Participants | 60 residents of two aged care facilities in Australia. N = 27 patients in intervention group; N = 33 patients in control group. |
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Interventions | Intervention group: Relaxation training and sleep hygiene. Relaxation training consisted of eight 40 minute sessions over three weeks. A passive relaxation technique was used. Participants were given a recording of relaxation training to practice between sessions. Participants were given information about sleep, anxiety and medication use. They were encouraged to use the relaxation procedures as a means of controlling anxiety and helping with sleep; they were also encouraged to reduce their use of BZDs. Medical and support staff were alerted to be vigilant to withdrawal effects and instructed to offer support. Control group: TAU. |
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Outcomes | Prescribed dose of BZDs. Sleep satisfaction, cognitive functioning, health rating and mood rating. Measures were taken at baseline, 1 month and 3 months. | |
Notes | Author supplied disaggregated data for self‐reported measures. Funding source: South Australian Health Commission (Section 16 grant). Declaration of interest: Not reported. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "One setting was designated by a coin toss, as the intervention setting and the other as a comparison setting". |
Allocation concealment (selection bias) | Unclear risk | Method of allocation concealment not reported. |
Blinding (performance bias and detection bias) All outcomes | Low risk | No blinding reported but the primary outcome was the number of BZD tablets given to patients by staff. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | No blinding or incomplete blinding, and the outcome is likely to be influenced by lack of blinding. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | No blinding reported but the primary outcome was the number of BZD tablets given to patients by staff. |
Blinding of outcome assessor (detection bias) subjective outcomes | Unclear risk | These outcomes are beyond the scope of this review. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No missing data. |
Selective reporting (reporting bias) | Low risk | The study protocol is not available but the published reports include all expected outcomes, including those that were pre‐specified in the method section. |