Clinical Study

The Interactive Relationship between Pain, Psychosis, and Agitation in People with Dementia: Results from a Cluster-Randomised Clinical Trial

Table 3

Efficacy of treating pain on psychosis and agitation in patients presenting one or more clinically significant symptoms at baseline (NPI-NH ≥ 4).

Baseline (SD)8 weeks (SD)

Control (n = 71)Intervention (n = 83)Control (n = 67)Intervention (n = 70) change
Psychosis cluster 10.5 (4.7)11.6 (5.9)0.3146.4 (5.3)5.6 (6.1)0.1480.034
Delusion 5.6 (4.2)6.9 (4.0)0.0433.2 (3.7)2.9 (3.6)0.7700.031
Hallucination 3.2 (3.8)3.3 (4.0)0.8132.1 (3.1)2.1 (3.3)0.9870.925
Euphoria 1.7 (2.9)1.4 (3.1)0.2111.0 (2.2)0.5 (1.9)0.0270.758

Control (n = 128)Intervention (n = 137)Control (n = 117)Intervention (n = 113)p change
Agitation cluster 17.4 (9.7)18.0 (9.6)0.42214.0 (11.0)8.8 (8.8)<0.001<0.001
Agitation/aggression4.7 (4.0)5.1 (4.2)0.4414.2 (4.0)2.5 (3.3)0.0010.004
Disinhibition3.9 (4.3)3.5 (4.0)0.6183.3 (4.2)1.9 (3.2)0.0080.211
Irritability4.8 (3.6)5.1 (4.1)0.6643.6 (3.6)2.6 (3.2)0.0230.183
Abb. motor behaviour4.0 (4.7)4.3 (4.9)0.6392.9 (3.9)1.8 (3.5)0.0080.007

Calculated by analyzing the difference between the intervention group and control group at each measurement point using the Mann-Whitney test.
Calculated by analyzing the difference in change of NPI-NH score in the intervention group versus the control group from baseline to Week 8 using the Mann-Whitney test.