| Methods |
Randomised controlled trial.
Randomisation method: not specified. |
| Participants |
14 caucasian male adults, affected by traumatic brain injury from road traffic accident, with GCS < = 8, consecutively admitted within 24 hours to the intensive care unit.
Experimental group: 7 subjects, mean age 27.7 (12.3), mean GCS: 4.8 (1.9)
Control group : 7 subjects, mean age 31.4 (11.2) mean GCS: 4.8 (1.4)
Patients with neurological or psychiatric disorders, alcohol or drug abuse, or previous head injuries were excluded. |
| Interventions |
Experimental group: stimulation of five senses for 20‐minute a day for all their stay in the ICU (median stay 8.1 days). Order of stimulus presentation was randomized.
Control group were not stimulated during the same period (stay medium 3.7 days). |
| Outcomes |
Glasgow Coma Scale (GCS), State of ventilation, Spontaneous eye movements, Oculocephalic response, Oculovestibular response, assessed daily.
Catecholamine levels, Serotonin level, Acetylcholinesterase level, 3‐methoxy,4‐hydroxyphenylglicol, skin conductance, heart rate, assessed 20 minutes pre‐ and post‐treatment period. |
| Notes |
Randomisation method not specified. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment? |
Unclear risk |
B ‐ Unclear |
