Table 2.
Outcome measures across time between the intervention and control groups among those children aged between 3 and 7 years (n=107)
| Control (n=55) | Intervention (n=52) | P values | Effect size (95% CI)* | |
| VAS anxiety scale (range: 0–100) | ||||
| T1 (before CR procedure) | 34.0 (30.0) | 35.4 (32.7) | ||
| T3 (after CR procedure) | 46.3 (37.3) | 27.6 (28.6) | 0.010† | 0.50 (0.11 to 0.88)‡ |
| Children’s Emotional Manifestation Scale (range: 5–25) | ||||
| T2 (during CR procedure)§ | 10.6 (4.7) | 8.1 (2.9) | 0.002¶ | 0.62 (0.23 to 1.01) |
| Heart rate (per minute) | ||||
| T1 (before CR procedure) | 88.7 (14.9) | 88.6 (14.5) | ||
| T2 (during CR procedure) | 95.8 (17.7) | 89.8 (16.6) | 0.081† | 0.33 (−0.05 to 0.71)‡ |
| T3 (after CR procedure) | 97.2 (15.6) | 90.0 (17.2) | 0.051† | 0.37 (−0.01 to 0.75)‡ |
| Parent satisfaction score (range: 10–50) | ||||
| T3 (after CR procedure) | 42.5 (6.7) | 47.3 (3.3) | <0.001¶ | 0.89 (0.49 to 1.28) |
| CR technician satisfaction score (range: 8–40) | ||||
| T3 (after CR procedure) | 31.5 (5.0) | 33.9 (3.7) | 0.007¶ | 0.54 (0.15 to 0.92) |
| Duration of procedure (min) | 4.8 (2.2) | 4.2 (2.0) | 0.126¶ | 0.30 (−0.08 to 0.68) |
Data of variables marked with † are presented as median (IQR), otherwise as mean (SD).
*Cohen’s d effect size.
†P value testing for differential change of heart rate at the underlying time point with respect to T1 by using GEE model.
‡The Cohen’s d effect size corresponds to the standardised mean difference of the mean changes at the underlying time point with respect to T1 between the intervention and control groups.
§Nature log-transformed before subjected to independent t-test.
¶Independent t-test.
CR, cast-removal; GEE, generalised estimating equations; VAS, Visual Analogue Scale.